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1.
Trials ; 25(1): 699, 2024 Oct 21.
Artículo en Inglés | MEDLINE | ID: mdl-39434191

RESUMEN

BACKGROUND: Some evidence suggests that fluid resuscitation with lactated Ringer's solution (LR) may have an anti-inflammatory effect on acute pancreatitis (AP) when compared to normal saline (NS) and may be associated with a decrease in severity, but existing single-center randomized controlled trials showed conflicting results. The WATERLAND trial aims to investigate the efficacy and safety of fluid resuscitation using LR compared to NS in patients with AP. METHODS: The WATERLAND trial is an international multicenter, open-label, parallel-group, randomized, controlled, superiority trial. Patients will be randomly assigned in a 1:1 ratio to receive LR versus NS-based fluid resuscitation for at least 48 h. The primary outcome will be moderately severe or severe AP, according to the revision of the Atlanta classification. The secondary objectives of the WATERLAND trial are to determine the effect of LR versus NS fluid resuscitation on several efficacy and safety outcomes in patients with AP. A total sample of 720 patients, 360 in the LR group and 360 in the NS group, will achieve 90% power to detect a difference between the group proportions of 10%, assuming that the frequency of moderately severe or severe AP in the LR group will be 17%. A loss to follow-up of 10% of patients is expected, so the total sample size will be 396 patients in each treatment arm (792 patients overall). The test statistic used is the two-sided Z test with pooled variance set at a 0.05 significance level. DISCUSSION: The WATERLAND study aims to improve the early management of AP. Fluid resuscitation is an inexpensive treatment available in any hospital center worldwide. If a better evolution of pancreatitis is demonstrated in one of the treatment arms, it would have important repercussions in the management of this frequent disease. TRIAL REGISTRATION: ClinicalTrials.gov, NCT05781243. Registration date on January 4, 2023. EudraCT number 2023-000010-18, first posted March 23, 2023.


Asunto(s)
Fluidoterapia , Estudios Multicéntricos como Asunto , Pancreatitis , Lactato de Ringer , Solución Salina , Humanos , Lactato de Ringer/administración & dosificación , Lactato de Ringer/efectos adversos , Pancreatitis/terapia , Fluidoterapia/métodos , Fluidoterapia/efectos adversos , Solución Salina/administración & dosificación , Solución Salina/efectos adversos , Resultado del Tratamiento , Resucitación/métodos , Resucitación/efectos adversos , Enfermedad Aguda , Estudios de Equivalencia como Asunto , Adulto , Masculino , Ensayos Clínicos Controlados Aleatorios como Asunto , Femenino , Persona de Mediana Edad , Factores de Tiempo
2.
J Trauma Acute Care Surg ; 92(1): 12-20, 2022 01 01.
Artículo en Inglés | MEDLINE | ID: mdl-34932039

RESUMEN

BACKGROUND: The combined injury of traumatic brain injury and hemorrhagic shock has been shown to worsen coagulopathy and systemic inflammation, thereby increasing posttraumatic morbidity and mortality. Aeromedical evacuation to definitive care may exacerbate postinjury morbidity because of the inherent hypobaric hypoxic environment. We hypothesized that blood product resuscitation may mitigate the adverse physiologic effects of postinjury flight. METHODS: An established porcine model of controlled cortical injury was used to induce traumatic brain injury. Intracerebral monitors were placed to record intracranial pressure, brain tissue oxygenation, and cerebral perfusion. Each of the 42 pigs was hemorrhaged to a goal mean arterial pressure of 40 ± 5 mm Hg for 1 hour. Pigs were grouped according to resuscitation strategy used-Lactated Ringer's (LR) or shed whole blood (WB)-then placed in an altitude chamber for 2 hours at ground, 8,000 ft, or 22,000 ft, and then observed for 4 hours. Hourly blood samples were analyzed for proinflammatory cytokines and lactate. Internal jugular vein blood flow was monitored continuously for microbubble formation with altitude changes. RESULTS: Cerebral perfusion, tissue oxygenation, and intracranial pressure were unchanged among the six study groups. Venous microbubbles were not observed even with differing altitude or resuscitation strategy. Serum lactate levels from hour 2 of flight to the end of observation were significantly elevated in 22,000 + LR compared with 8,000 + LR and 22,000 + WB. Serum IL-6 levels were significantly elevated in 22,000 + LR compared with 22,000 + WB, 8,000 + LR and ground+LR at hour 1 of observation. Serum tumor necrosis factor-α was significantly elevated at hour 2 of flight in 8,000 + LR versus ground+LR, and in 22,000 + LR vs. 22,000 + WB at hour 1 of observation. Serum IL-1ß was significantly elevated hour 1 of flight between 8,000 + LR and ground+LR. CONCLUSION: Crystalloid resuscitation during aeromedical transport may cause a prolonged lactic acidosis and proinflammatory response that can predispose multiple-injury patients to secondary cellular injury. This physiologic insult may be prevented by using blood product resuscitation strategies.


Asunto(s)
Ambulancias Aéreas , Transfusión Sanguínea/métodos , Lesiones Traumáticas del Encéfalo , Soluciones Cristaloides , Resucitación/métodos , Lactato de Ringer , Choque Hemorrágico , Animales , Lesiones Traumáticas del Encéfalo/complicaciones , Lesiones Traumáticas del Encéfalo/fisiopatología , Lesiones Traumáticas del Encéfalo/terapia , Circulación Cerebrovascular/efectos de los fármacos , Circulación Cerebrovascular/fisiología , Soluciones Cristaloides/administración & dosificación , Soluciones Cristaloides/efectos adversos , Modelos Animales de Enfermedad , Presión Intracraneal/efectos de los fármacos , Presión Intracraneal/fisiología , Traumatismo Múltiple/fisiopatología , Traumatismo Múltiple/terapia , Monitorización Neurofisiológica/métodos , Consumo de Oxígeno/efectos de los fármacos , Consumo de Oxígeno/fisiología , Lactato de Ringer/administración & dosificación , Lactato de Ringer/efectos adversos , Choque Hemorrágico/complicaciones , Choque Hemorrágico/fisiopatología , Choque Hemorrágico/terapia , Porcinos , Resultado del Tratamiento
3.
Pancreas ; 50(2): 189-195, 2021 02 01.
Artículo en Inglés | MEDLINE | ID: mdl-33565794

RESUMEN

OBJECTIVES: Early intravenous fluid (IVF) resuscitation is crucial in the management of acute pancreatitis; variation in IVF prescription practice had been demonstrated. This pilot study aims to assess whether the implementation of an Acute Pancreatitis Care Pathway (APCP) produces a change toward a more adequate IVF regimen in the first 24 hours. METHODS: Patients with confirmed diagnosis of acute pancreatitis, from July 2015 to February 2016 (group 1) and from September 2017 to March 2018 (group 2), were considered. The APCP was developed between March 2016 and August 2017. Median IVF rate, volume, and type infused in the first 24 hours, were compared between groups. Nonparametric data were analyzed with the Mann-Whitney U test, differences in frequencies with the McNemar test; significance was set at P < 0.05. RESULTS: Seventy-two patients were included, 36 in each group. In the first 24 hours, the median IVF rate was 177 mL/h vs 225 mL/h (P = 0.004); Ringer lactate infusion was 30% vs 77.8% (P = 0.0003). The median total IVF volume did not differ between groups. CONCLUSIONS: The implementation of the APCP has the potential to lead to a successful change in early IVF resuscitation practice.


Asunto(s)
Vías Clínicas , Fluidoterapia , Pancreatitis/terapia , Resucitación , Lactato de Ringer/administración & dosificación , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Femenino , Fluidoterapia/efectos adversos , Humanos , Infusiones Intravenosas , Masculino , Persona de Mediana Edad , Pancreatitis/diagnóstico , Pancreatitis/fisiopatología , Admisión del Paciente , Proyectos Piloto , Evaluación de Programas y Proyectos de Salud , Mejoramiento de la Calidad , Indicadores de Calidad de la Atención de Salud , Lactato de Ringer/efectos adversos , Factores de Tiempo , Resultado del Tratamiento , Adulto Joven
4.
Anesth Analg ; 133(2): 413-422, 2021 08 01.
Artículo en Inglés | MEDLINE | ID: mdl-32947291

RESUMEN

BACKGROUND: The intraoperative effect of 20% albumin on plasma volume during surgery involving major blood loss has not been explored extensively due to methodological difficulties. Crystalloids poorly expand the plasma volume, and using a colloid might then be a way to avoid fluid overload. As doubts have been raised about synthetic colloids, albumin solutions are currently used more extensively. This study presents a methodological development showing how plasma volume expansion can be studied in surgical settings with the coinfusion of 20% albumin and lactated Ringer's solution. METHODS: In this single-arm, single-center feasibility study, an intravenous (i.v.) infusion of 3 mL·kg·BW-1 of 20% albumin was administered over 30 minutes to 23 cystectomy patients during the bleeding phase in addition to lactated Ringer's solution to correct blood loss. Blood samples were measured at regular intervals over a period of 300 minutes to estimate the blood volume expansion resulting from simultaneous infusions of lactated Ringer's and 20% albumin solutions, using a regression equation and the area under the volume-time curve method. RESULTS: Mean hemorrhage was 974 mL (standard deviation [SD] ± 381). The regression method showed strong correlation (r2 = 0.58) between blood loss minus blood volume expansion and the independent effects of the infused volume of lactated Ringer's and 20% albumin solutions. The mean plasma volume expansion attributable to the infusion of lactated Ringer's solution amounted to 0.38 (95% confidence interval [CI], 0.31-0.49) of the infused volume; for the 20% albumin, it was 1.94 mL/mL (95% CI, 1.41-2.46 mL/mL) over 5 hours on average (regression method). The mean within-patient change was 0.20 mL/mL (± 0.06 mL/mL) for the lactated Ringer's solution and 2.20 mL/mL (±1.31 mL/mL) for the 20% albumin using the area under the volume-time curve method. CONCLUSIONS: Blood volume expansion averaged 1.9-2.2 times the infused volume of 20% albumin during surgery associated with hemorrhage of around 1000 mL. This effect was long standing and approximately 5 times stronger than for the lactated Ringer's solution. Twenty percent albumin boosts the plasma volume expansion of lactated Ringer's solution to as high as 40% of the infused volume on the average, which is an effect that lasts at least 5 hours.


Asunto(s)
Albúminas/administración & dosificación , Pérdida de Sangre Quirúrgica/prevención & control , Cistectomía/efectos adversos , Fluidoterapia , Sustitutos del Plasma/administración & dosificación , Volumen Plasmático , Lactato de Ringer/administración & dosificación , Anciano , Albúminas/efectos adversos , Estudios de Factibilidad , Femenino , Fluidoterapia/efectos adversos , Humanos , Infusiones Intravenosas , Cuidados Intraoperatorios , Masculino , Persona de Mediana Edad , Sustitutos del Plasma/efectos adversos , Estudios Prospectivos , Lactato de Ringer/efectos adversos , Suiza , Factores de Tiempo , Resultado del Tratamiento
6.
Repert. med. cir ; 30(1): 43-47, 2021. tab.
Artículo en Inglés, Español | LILACS, COLNAL | ID: biblio-1284478

RESUMEN

Introducción: los cristaloides son medicamentos usados en pacientes críticamente enfermos, con resultados ambiguos cuando se utilizan soluciones balanceadas versus solución salina normal. Objetivo: conocer si existen diferencias al usar solución salina 0.9% vs. lactato de Ringer en pacientes críticamente enfermos con sepsis y choque séptico o hipovolémico, en cuanto a mortalidad, lesión renal aguda y tiempo de estancia hospitalaria. Métodos: estudio observacional de tipo cohorte retrospectiva en mayores de 18 años con diagnóstico de sepsis, choque séptico o hipovolémico. Se excluyeron aquellos con enfermedad renal crónica en diálisis, las hospitalizadas por ginecología/obstetricia y aquellos con diagnóstico de muerte encefálica o donantes de órganos. Se evaluaron los desenlaces primarios de mortalidad, lesión renal aguda y estancia hospitalaria. Resultados y discusión: se incluyeron 314 pacientes, 158 en el grupo expuesto a solución salina al 0.9% y 156 con lactato de Ringer. Se presentó lesión renal aguda en 22.7% con solución salina y 25.8% con lactato de Ringer (OR 1.18 IC 95%:0.7-2). La mortalidad con solución salina fue de 49%, y en lactato 49% (OR 1.01 IC 95%:0.63-1.63). Los factores de riesgo identificados para mortalidad fueron uso de soporte vasopresor (OR 35 IC 95% 12-83) y lesión renal aguda (1.3 IC 95% 1.01-1.69). Conclusiones: en el paciente críticamente enfermo con sepsis, choque séptico o hipovolémico el uso desolución salina 0.9% no representa diferencias al compararlo con lactato de Ringer en cuanto a mortalidad, lesión renal aguda o estancia hospitalaria. La elección de un cristaloide debe ser individualizada, teniendo en cuenta las comorbilidades, la presencia de hipercloremia o hiperpotasemia.


Objective: crystalloids are drugs used in critically ill patients, with ambiguous results when balanced solutions versus normal saline solution (NS) are used. The objective of this study is to determine if there are differences when NS (0.9%) vs. lactated Ringer ́s (LR) solution are given to critically ill patients in sepsis or septic or hypovolemic shock, in terms of mortality, acute renal injury and length of hospital stay. Methods: a retrospective observational cohort study in patients over 18 years old with sepsis or septic or hypovolemic shock. Patients with chronic renal disease on dialysis, those hospitalized by gynecology/obstetrics and those diagnosed with brain death or organ donors were excluded. The primary mortality outcomes, acute renal injury and hospital stay were evaluated. Results: 314 patients were included, 158 in the NS group and 156 in the LR group. Acute renal injury occurred in 22.7% in the NS group and 25.8% in the LR group (OR 1.18 IC 95%:0.7-2). Mortality rate was 49% in the NS group and 49% in the LR group (OR 1.01 95%: CI 0.63-1.63). Mortality risk factors included the use of vasopressor support (OR 35 95% CI 12-83) and acute renal injury (1.3 95% CI 1.01-1.69). Conclusions: no difference was found with the use of NS in critically ill patients with sepsis or septic or hypovolemic shock when compared with LR in terms of mortality, acute renal injury or hospital stay. The choice of which crystalloid to administer should be individualized, based on the comorbidities and the presence of hyperchloremia or hyperkalemia.


Asunto(s)
Humanos , Masculino , Femenino , Adulto , Persona de Mediana Edad , Anciano , Anciano de 80 o más Años , Choque/terapia , Sepsis/terapia , Lactato de Ringer/uso terapéutico , Solución Salina/uso terapéutico , Choque/mortalidad , Choque Séptico/mortalidad , Choque Séptico/terapia , Análisis Multivariante , Estudios Retrospectivos , Resultado del Tratamiento , Sepsis/mortalidad , Lesión Renal Aguda/inducido químicamente , Lactato de Ringer/efectos adversos , Solución Salina/efectos adversos , Tiempo de Internación
7.
Pancreas ; 49(3): 375-380, 2020 03.
Artículo en Inglés | MEDLINE | ID: mdl-32132512

RESUMEN

OBJECTIVE: The aim of the study was to evaluate lactated ringers (LR) versus normal saline (NS) in pediatric acute pancreatitis (AP). METHODS: This retrospective study used Pediatric Health Information System database of primary AP patients, 2013 to 2017. RESULTS: The study included 1581 first time AP patients with exclusive use of a single fluid (111 LR, 1470 NS) for the first 48 hours. The LR cohort had a significantly shorter length of stay (P < 0.001) compared with NS. A multivariable logistic regression analysis suggests use of NS in the first 48 hours (after controlling for total parenteral nutrition, operation, and infection during the admission) had a significantly increased likelihood of requiring a hospitalization for 4 days or more compared with the LR group (odds ratio, 3.31; 95% confidence interval, 1.95-5.62). The overall cost was significantly less in the LR group. There was no statistical difference observed in risk factors for AP, intensive care transfer, organ dysfunction, or mortality. CONCLUSIONS: This represents the first large data set analysis of LR versus NS in pediatric AP. The use of LR was associated with a shorter length of stay and reduced cost compared with NS. Future randomized trials will help determine the ideal fluid choice for pediatric AP.


Asunto(s)
Fluidoterapia , Tiempo de Internación , Pancreatitis/terapia , Lactato de Ringer/administración & dosificación , Solución Salina/administración & dosificación , Adolescente , Factores de Edad , Niño , Ahorro de Costo , Análisis Costo-Beneficio , Bases de Datos Factuales , Femenino , Fluidoterapia/efectos adversos , Fluidoterapia/economía , Costos de Hospital , Humanos , Masculino , Pancreatitis/diagnóstico , Pancreatitis/economía , Estudios Retrospectivos , Lactato de Ringer/efectos adversos , Lactato de Ringer/economía , Solución Salina/efectos adversos , Solución Salina/economía , Factores de Tiempo , Resultado del Tratamiento , Estados Unidos
10.
Anesthesiology ; 132(4): 614-624, 2020 04.
Artículo en Inglés | MEDLINE | ID: mdl-31977517

RESUMEN

BACKGROUND: Both saline and lactated Ringer's solutions are commonly given to surgical patients. However, hyperchloremic acidosis consequent to saline administration may provoke complications. The authors therefore tested the primary hypothesis that a composite of in-hospital mortality and major postoperative complications is less common in patients given lactated Ringer's solution than normal saline. METHODS: The authors conducted an alternating cohort controlled trial in which adults having colorectal and orthopedic surgery were given either lactated Ringer's solution or normal saline in 2-week blocks between September 2015 and August 2018. The primary outcome was a composite of in-hospital mortality and major postoperative renal, respiratory, infectious, and hemorrhagic complications. The secondary outcome was postoperative acute kidney injury. RESULTS: Among 8,616 qualifying patients, 4,187 (49%) were assigned to lactated Ringer's solution, and 4,429 (51%) were assigned to saline. Each group received a median 1.9 l of fluid. The primary composite of major complications was observed in 5.8% of lactated Ringer's versus 6.1% of normal saline patients, with estimated average relative risk across the components of the composite of 1.16 (95% CI, 0.89 to 1.52; P = 0.261). The secondary outcome, postoperative acute kidney injury, Acute Kidney Injury Network stage I-III versus 0, occurred in 6.6% of lactated Ringer's patients versus 6.2% of normal saline patients, with an estimated relative risk of 1.18 (99.3% CI, 0.99 to 1.41; P = 0.009, significance criterion of 0.007). Absolute differences between the treatment groups for each outcome were less than 0.5%, an amount that is not clinically meaningful. CONCLUSIONS: In elective orthopedic and colorectal surgery patients, there was no clinically meaningful difference in postoperative complications with lactated Ringer's or saline volume replacement. Clinicians can reasonably use either solution intraoperatively.


Asunto(s)
Mortalidad Hospitalaria/tendencias , Cuidados Intraoperatorios/métodos , Complicaciones Posoperatorias/mortalidad , Lactato de Ringer/administración & dosificación , Solución Salina/administración & dosificación , Adulto , Anciano , Femenino , Humanos , Infusiones Intravenosas , Cuidados Intraoperatorios/efectos adversos , Masculino , Persona de Mediana Edad , Complicaciones Posoperatorias/inducido químicamente , Complicaciones Posoperatorias/diagnóstico , Lactato de Ringer/efectos adversos , Solución Salina/efectos adversos
11.
Acta Anaesthesiol Scand ; 64(4): 538-545, 2020 04.
Artículo en Inglés | MEDLINE | ID: mdl-31738447

RESUMEN

BACKGROUND: Fluid-induced hypervolemia may stimulate the release of natriuretic peptides and cause degradation (shedding) of the endothelial glycocalyx layer. Sevoflurane is believed to protect the glycocalyx, but the importance of using sevoflurane to prevent shedding during routine surgery is unclear. METHODS: The plasma concentrations of brain natriuretic peptide and two biomarkers of glycocalyx shedding, syndecan-1, and heparan sulfate, were measured in 26 patients randomized to receive general anesthesia with sevoflurane or propofol during open abdominal hysterectomy. The fluid therapy consisted of 25 mL/kg (approximately 2 L) of Ringer´s lactate over 30 minutes. Blood hemoglobin and plasma albumin were used to indicate plasma volume expansion and capillary leakage. RESULTS: The plasma concentrations of brain natriuretic peptide and shedding products showed low levels throughout the surgery (median brain natriuretic peptide, 21 ng/L; syndecan-1, 12.9 ng/mL; and heparan sulfate, 6.5 µg/mL), but the heparan sulfate concentration increased 2 hours post-operatively (to 17.3 µg/mL, P < .005). No differences were noted between the propofol and sevoflurane groups in any of the measured parameters. Albumin was apparently recruited to the bloodstream during the first 20 minutes, when the intravascular retention of infused fluid was almost 100%. The urine flow was <1 mL/min, despite the vigorous volume loading. CONCLUSIONS: No relevant elevations of brain natriuretic peptide or degradation products of the glycocalyx layer were observed when hypervolemia was induced during open abdominal hysterectomy performed with sevoflurane or propofol anesthesia. Plasma volume expansion from Ringer´s lactate was pronounced.


Asunto(s)
Endotelio Vascular/metabolismo , Fluidoterapia/efectos adversos , Glicocálix/metabolismo , Histerectomía , Propofol/farmacología , Sevoflurano/farmacología , Adulto , Anestésicos por Inhalación/farmacología , Anestésicos Intravenosos/farmacología , Femenino , Fluidoterapia/métodos , Glicocálix/efectos de los fármacos , Heparitina Sulfato/sangre , Humanos , Letonia , Masculino , Persona de Mediana Edad , Péptido Natriurético Encefálico/sangre , Péptido Natriurético Encefálico/efectos de los fármacos , Lactato de Ringer/efectos adversos , Sindecano-1/sangre , Desequilibrio Hidroelectrolítico/complicaciones
12.
Crit Care ; 23(1): 159, 2019 05 06.
Artículo en Inglés | MEDLINE | ID: mdl-31060591

RESUMEN

BACKGROUND: Recent evidence suggests that acetate-buffered infusions result in better hemodynamic stabilization than 0.9% saline in patients undergoing major surgery. The choice of buffer in balanced crystalloid solutions may modify their hemodynamic effects. We therefore compared the inopressor requirements of Ringer's acetate and lactate for perioperative fluid management in patients undergoing cardiac surgery. METHODS: Using a randomized controlled double-blind design, we compared Ringer's acetate (RA) to Ringer's lactate (RL) with respect to the average rate of inopressor administered until postoperative hemodynamic stabilization was achieved. Secondary outcomes were the cumulative dose of inopressors, the duration of inopressor administration, the total fluid volume administered, and the changes in acid-base homeostasis. Patients undergoing elective valvular cardiac surgery were included. Patients with severe cardiac, renal, or liver disease were excluded from the study. RESULTS: Seventy-five patients were randomly allocated to the RA arm, 73 to the RL. The hemodynamic profiles were comparable between the groups. The groups did not differ with respect to the average rate of inopressors (RA 2.1 mcg/kg/h, IQR 0.5-8.1 vs. RL 1.7 mcg/kg/h, IQR 0.7-8.2, p = 0.989). Cumulative doses of inopressors and time on individual and combined inopressors did not differ between the groups. No differences were found in acid-base parameters and their evolution over time. CONCLUSION: In this study, hemodynamic profiles of patients receiving Ringer's lactate and Ringer's acetate were comparable, and the evolution of acid-base parameters was similar. These study findings should be evaluated in larger, multi-center studies. TRIAL REGISTRATION: Clinicaltrials.gov NCT02895659 . Registered 16 September 2016.


Asunto(s)
Fluidoterapia/normas , Hemodinámica/efectos de los fármacos , Soluciones Isotónicas/farmacología , Lactato de Ringer/farmacología , Anciano , Análisis de los Gases de la Sangre , Tampones (Química) , Procedimientos Quirúrgicos Cardíacos/métodos , Procedimientos Quirúrgicos Cardíacos/normas , Método Doble Ciego , Femenino , Fluidoterapia/métodos , Humanos , Soluciones Isotónicas/efectos adversos , Soluciones Isotónicas/uso terapéutico , Modelos Lineales , Masculino , Persona de Mediana Edad , Monitoreo Fisiológico/métodos , Monitoreo Fisiológico/estadística & datos numéricos , Lactato de Ringer/efectos adversos , Lactato de Ringer/uso terapéutico , Factores de Tiempo
13.
Microvasc Res ; 123: 14-18, 2019 05.
Artículo en Inglés | MEDLINE | ID: mdl-30448399

RESUMEN

BACKGROUND: Clinical evaluation of the effects of fluid therapy remains cumbersome and strategies are based on the assumption that normalization of macrohemodynamic variables will result in parallel improvement in organ perfusion. Recently, we and others suggested the use of direct in-vivo observation of the microcirculation to evaluate the effects of fluid therapy. METHODS: A single-centre observational study, using in-vivo microscopy to assess total vessel density (TVD) in two subsets of ICU patients. RESULTS: After fluid resuscitation TVD showed no difference between sepsis patients (N = 47) and cardiac surgery patients (N = 52): 18.4[16.8-20.8] vs 18.7[16.8-20.9] mm/mm2, p = 0.59. In cardiac surgery patients there was a significant correlation between the amount of fluids administered and TVD, with an optimum in the third quartile. However, such correlation was absent in septic patients. CONCLUSIONS: TVD after fluid administration is not different between 2 subtypes of intensive care patients. However, only in septic patients we observed a lack of coherence between the amount of fluids administered and TVD. Further research is needed to determine if TVD may serve as potential endpoint for fluid administration.


Asunto(s)
Capilares/fisiopatología , Procedimientos Quirúrgicos Cardíacos , Fluidoterapia/métodos , Hemodinámica , Microcirculación , Resucitación/métodos , Lactato de Ringer/administración & dosificación , Sepsis/terapia , Anciano , Edema/diagnóstico , Edema/etiología , Edema/fisiopatología , Femenino , Fluidoterapia/efectos adversos , Humanos , Unidades de Cuidados Intensivos , Masculino , Microscopía/métodos , Persona de Mediana Edad , Resucitación/efectos adversos , Lactato de Ringer/efectos adversos , Sepsis/diagnóstico , Sepsis/fisiopatología , Resultado del Tratamiento
14.
Ned Tijdschr Geneeskd ; 1622018 Jun 07.
Artículo en Holandés | MEDLINE | ID: mdl-30040329

RESUMEN

We previously suggested that choosing balanced solutions over normal saline for fluid therapy might benefit patients. After all, administration of NaCl 0.9% invokes metabolic acidosis and hyperchloraemia which was linked to renal failure and mortality in retrospective studies. Two large randomized controlled clinical trials now confirm this signal. Both in intensive care patients and in the setting of emergency medicine, balanced solutions were shown to reduce the incidence of MAKE30, a composite end point of hospital mortality and indices of renal failure. In addition, predefined subgroup analysis revealed increased mortality for normal saline in intensive care patients with sepsis. Even though the effect size is small in both studies, this evidence against normal saline is hard to ignore, given the immense number of patients who receive NaCl 0.9% worldwide. Therefore, clinical medicine may shortly witness the quiet disappearance of normal saline.


Asunto(s)
Solución Salina/efectos adversos , Cuidados Críticos , Electrólitos/administración & dosificación , Electrólitos/efectos adversos , Fluidoterapia/efectos adversos , Fluidoterapia/métodos , Mortalidad Hospitalaria , Humanos , Ensayos Clínicos Controlados Aleatorios como Asunto , Estudios Retrospectivos , Lactato de Ringer/administración & dosificación , Lactato de Ringer/efectos adversos , Solución Salina/administración & dosificación , Sepsis/terapia
15.
Trials ; 19(1): 207, 2018 Apr 02.
Artículo en Inglés | MEDLINE | ID: mdl-29606135

RESUMEN

BACKGROUND: Post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP) is the most common complication of ERCP and may run a severe course. Evidence suggests that vigorous periprocedural hydration can prevent PEP, but studies to date have significant methodological drawbacks. Importantly, evidence for its added value in patients already receiving prophylactic rectal non-steroidal anti-inflammatory drugs (NSAIDs) is lacking and the cost-effectiveness of the approach has not been investigated. We hypothesize that combination therapy of rectal NSAIDs and periprocedural hydration would significantly lower the incidence of post-ERCP pancreatitis compared to rectal NSAIDs alone in moderate- to high-risk patients undergoing ERCP. METHODS: The FLUYT trial is a multicenter, parallel group, open label, superiority randomized controlled trial. A total of 826 moderate- to high-risk patients undergoing ERCP that receive prophylactic rectal NSAIDs will be randomized to a control group (no fluids or normal saline with a maximum of 1.5 mL/kg/h and 3 L/24 h) or intervention group (lactated Ringer's solution with 20 mL/kg over 60 min at start of ERCP, followed by 3 mL/kg/h for 8 h thereafter). The primary endpoint is the incidence of post-ERCP pancreatitis. Secondary endpoints include PEP severity, hydration-related complications, and cost-effectiveness. DISCUSSION: The FLUYT trial design, including hydration schedule, fluid type, and sample size, maximize its power of identifying a potential difference in post-ERCP pancreatitis incidence in patients receiving prophylactic rectal NSAIDs. TRIAL REGISTRATION: EudraCT: 2015-000829-37 . Registered on 18 February 2015. ISRCTN: 13659155 . Registered on 18 May 2015.


Asunto(s)
Antiinflamatorios no Esteroideos/administración & dosificación , Pancreatitis/prevención & control , Ensayos Clínicos Controlados Aleatorios como Asunto , Lactato de Ringer/administración & dosificación , Administración Rectal , Adulto , Anciano , Anciano de 80 o más Años , Antiinflamatorios no Esteroideos/efectos adversos , Colangiopancreatografia Retrógrada Endoscópica/efectos adversos , Recolección de Datos , Humanos , Persona de Mediana Edad , Estudios Multicéntricos como Asunto , Lactato de Ringer/efectos adversos , Tamaño de la Muestra
16.
Trials ; 19(1): 170, 2018 Mar 07.
Artículo en Inglés | MEDLINE | ID: mdl-29514697

RESUMEN

BACKGROUND: Patients with liver cirrhosis undergoing liver transplantation have a hyperdynamic circulation which persists into the early postoperative period making accurate assessment of fluid requirements challenging. Goal-directed fluid therapy (GDFT) has been shown to reduce morbidity and mortality in a number of surgery settings. The impact of GDFT in patients undergoing liver transplantation is unknown. A feasibility trial was designed to determine patient and clinician support for recruitment into a randomised controlled trial of GDFT following liver transplantation, adherence to a GDFT protocol, participant withdrawal, and to determine appropriate endpoints for a subsequent larger trial to evaluate the efficacy of GDFT in patients undergoing liver transplantation. METHODS: The Cardiac output Optimisation following Liver Transplant (COLT) trial is designed as a prospective, single-centre, randomised controlled study to assess the feasibility and safety of GDFT in liver transplantation for patients with cirrhosis. Consenting adults (aged between 18 and 80 years) with biopsy-proven liver cirrhosis who have been selected to undergo a first liver transplantation will be included in the trial and randomised into GDFT or standard care starting immediately after surgery and continuing for the first 12 h thereafter. Both groups will have cardiac output and stroke volume monitored using the FloTrac (EV1000) device. The intervention will consist of a protocolised GDFT approach to patient management, using stroke volume optimisation. The control group will receive standard care, without stroke volume and cardiac output measurement. After 12 h the patient's fluid management will revert to standard of care. The primary endpoint of this study is feasibility. Secondary endpoints will include a safety assessment of the intervention, graft and patient survival, liver function, postoperative complications graded by Clavien-Dindo criteria, length of intensive care and hospital stay and quality of life across the intervention and control groups. DISCUSSION: There is a growing body of evidence that the use of perioperative GDFT in surgical patients can improve outcomes; however, signals of harm have also been detected. Patients with liver cirrhosis undergoing liver transplantation have markedly different cardiovascular physiology than general surgical patients. If GDFT is proven to be feasible and safe in this patient group, then a multicentre trial to demonstrate efficacy and cost-effectiveness will be required. TRIAL REGISTRATION: International Standard Randomised Controlled Trial Registry, ID: ISRCTN10329248. Registered on 4 April 2016.


Asunto(s)
Gasto Cardíaco , Fluidoterapia/métodos , Cirrosis Hepática/cirugía , Trasplante de Hígado , Atención Perioperativa/métodos , Lactato de Ringer/administración & dosificación , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Biopsia , Estudios de Factibilidad , Femenino , Fluidoterapia/efectos adversos , Humanos , Infusiones Intravenosas , Cirrosis Hepática/diagnóstico , Cirrosis Hepática/fisiopatología , Trasplante de Hígado/efectos adversos , Londres , Masculino , Persona de Mediana Edad , Atención Perioperativa/efectos adversos , Estudios Prospectivos , Ensayos Clínicos Controlados Aleatorios como Asunto , Recuperación de la Función , Lactato de Ringer/efectos adversos , Factores de Riesgo , Factores de Tiempo , Resultado del Tratamiento , Adulto Joven
17.
Afr J Paediatr Surg ; 15(2): 69-72, 2018.
Artículo en Inglés | MEDLINE | ID: mdl-31290466

RESUMEN

BACKGROUND: It is a common practice to administer 4.3% dextrose in 0.18% saline peri-operatively and for routine fluid maintenance in the paediatric age group. Concerns have been expressed about the risk of hyponatraemia associated with the administration of hypotonic intravenous fluids, hence the need to re-evaluate our practice. This study aims to evaluate the relative incidence of intra-operative hyponatraemia following the use of isotonic and hyopotonic intravenous fluids. PATIENTS AND METHODS: This randomised double-blind clinical trial recruited consecutive American Society of Anaesthesiologists physical status Class I and II children aged between 6 months and 17 years scheduled for various minor elective surgical procedures. The patients received one of 3 intravenous infusions for intra-operative fluid management. Group I received 4.3% dextrose in 0.18 saline (n = 25), Group II received normal saline (n = 20) and Group III received Ringer's lactate (n = 20). Blood samples were collected before the surgery and at the end of surgery for serum electrolytes. RESULTS: One patient in each group developed moderate hyponatraemia intraoperatively. This constituted a 4% (1/25) incidence of intra-operative hyponatraemia among patients who had hypotonic maintenance fluid and a 5% (2/40) incidence in the isotonic maintenance groups. The incidence of hyponatraemia was therefore comparable between patients who had hypotonic and isotonic intra-operative maintenance fluids (P = 1.000). CONCLUSION: We conclude that healthy children who have intraoperative hypotonic maintenance fluids during minor elective surgeries are not exposed to the additional risk of hyponatraemia compared to those who have isotonic fluids. The study of a larger sample size is recommended to further validate our findings.


Asunto(s)
Fluidoterapia/efectos adversos , Hiponatremia/epidemiología , Soluciones Hipotónicas/efectos adversos , Soluciones Isotónicas/efectos adversos , Lactato de Ringer/efectos adversos , Sodio/sangre , Procedimientos Quirúrgicos Operativos , Adolescente , Niño , Preescolar , Método Doble Ciego , Femenino , Humanos , Hiponatremia/sangre , Hiponatremia/inducido químicamente , Soluciones Hipotónicas/administración & dosificación , Incidencia , Lactante , Infusiones Intravenosas , Periodo Intraoperatorio , Soluciones Isotónicas/administración & dosificación , Masculino , Nigeria/epidemiología , Lactato de Ringer/administración & dosificación
18.
Catheter Cardiovasc Interv ; 91(2): 234-241, 2018 02 01.
Artículo en Inglés | MEDLINE | ID: mdl-28636165

RESUMEN

OBJECTIVES: We designed a pilot study to evaluate safety and feasibility of an inexpensive and simple approach to intracoronary hemodilution during primary angioplasty (PPCI) to reduce reperfusion injury. INTRODUCTION: Early revascularization in acute myocardial infarction decreases infarct size and improves outcomes. However, abrupt restoration of coronary flow results in myocardial reperfusion injury and increased final infarct size. Dilution of coronary blood during revascularization may help reduce this damage. If proved effective, such an approach would need to be simple and suitable for widespread adoption. METHODS: Ten patients presenting with STEMI underwent intracoronary dilution with room temperature Hartmann's solution delivered through the guiding catheter during primary angioplasty (PPCI). Infusion of perfusate began prior to crossing the occluded artery with the guidewire, continuing until 10 min after completion of the balloon and stenting procedure. Infusion was briefly interrupted for contrast injection and pressure monitoring. The outcome measures were safety, including intracoronary temperature reduction and volume of intracoronary perfusate infused, and technical feasibility. RESULTS: There were no significant symptomatic, hemodynamic, ECG ST/T segment or rhythm changes observed during perfusate administration. The median (interquartile range) volume of perfusate administered was 550 mL (350-725 mL) and the median intracoronary temperature reduction observed was 3.4°Celsius. Myocardial salvage was 0.54 (0.43-0.65). CONCLUSIONS: Transcatheter intracoronary hemodilution with room temperature perfusate during PPCI is feasible and appears safe. Such a strategy is simple and inexpensive, with potential to be widely applied. Further mechanistic and subsequent outcome powered studies are required to evaluate whether this strategy can reduce reperfusion injury in STEMI.


Asunto(s)
Angioplastia Coronaria con Balón , Hemodilución/métodos , Daño por Reperfusión Miocárdica/prevención & control , Lactato de Ringer/administración & dosificación , Infarto del Miocardio con Elevación del ST/terapia , Angioplastia Coronaria con Balón/efectos adversos , Angioplastia Coronaria con Balón/instrumentación , Circulación Coronaria , Electrocardiografía , Estudios de Factibilidad , Femenino , Hemodilución/efectos adversos , Humanos , Imagen por Resonancia Cinemagnética , Masculino , Persona de Mediana Edad , Daño por Reperfusión Miocárdica/diagnóstico por imagen , Daño por Reperfusión Miocárdica/etiología , Proyectos Piloto , Estudios Prospectivos , Lactato de Ringer/efectos adversos , Factores de Riesgo , Infarto del Miocardio con Elevación del ST/diagnóstico por imagen , Infarto del Miocardio con Elevación del ST/fisiopatología , Stents , Factores de Tiempo , Resultado del Tratamiento
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