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1.
Ann Surg ; 2024 May 06.
Artículo en Inglés | MEDLINE | ID: mdl-38708888

RESUMEN

OBJECTIVE: To compare the effect of balanced multielectrolyte solutions(BMES) versus normal saline(NS) for intravenous fluid on chloride levels and clinical outcomes.in patients with predicted severe acute pancreatitis (pSAP). SUMMARY BACKGROUND DATA: Isotonic crystalloids are recommended for initial fluid therapy in acute pancreatitis, but whether the use of BMES in preference to NS confers clinical benefits is unknown. METHODS: In this multicenter, stepped-wedge, cluster-randomized trial, we enrolled patients with pSAP (APACHE II score ≥8 and C-reactive protein >150 mg/L) admitted within 72 hours of the advent of symptoms. The study sites were randomly assigned to staggered start dates for one-way crossover from the NS phase (NS for intravenous fluid) to the BMES phase(Sterofudin for intravenous fluid). The primary endpoint was the serum chloride concentration on trial day3. Secondary endpoints included a composite of clinical and laboratory measures. RESULTS: Overall, 259 patients were enrolled from eleven sites to receive NS(n=147) or BMES(n=112). On trial day3, the mean chloride level was significantly lower in patients who received BMES(101.8 mmol/L(SD4.8) versus 105.8 mmol/L(SD5.9), difference -4.3 mmol/L [95%CI -5.6 to -3.0 mmol/L];P<0.001). For secondary endpoints, patients who received BMES had less systemic inflammatory response syndrome(19/112,17.0% versus 43/147,29.3%, P=0.024) and increased organ failure-free days (3.9 d(SD2.7) versus 3.5days(SD2.7), P<0.001) by trial day7. They also spent more time alive and out of ICU(26.4 d(SD5.2) versus 25.0days(SD6.4), P=0.009) and hospital(19.8 d(SD6.1) versus16.3days(SD7.2), P<0.001) by trial day30. CONCLUSIONS: Among patients with pSAP, using BMES in preference to NS resulted in a significantly more physiological serum chloride level, which was associated with multiple clinical benefits(Trial registration number: ChiCTR2100044432).

2.
Ophthalmic Physiol Opt ; 44(1): 17-22, 2024 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-37921119

RESUMEN

PURPOSE: The accurate diagnosis of age-related macular degeneration (AMD) represents an important step in delaying and preventing vision loss and achieving optimal patient care. Therefore, this pilot study aimed to estimate the diagnostic accuracy of community optometrists for identifying AMD using colour fundus photographs (CFPs) to support sample size calculations for subsequent definitive studies. METHODS: Five practising community optometrists were invited to classify a total of 1023 CFPs for the (1) presence of AMD, and, if applicable, (2) stage of AMD (early/intermediate/late geographic atrophy/late neovascular AMD). Diagnosis by referral centre clinicians formed the reference standard. Diagnostic accuracy was assessed by the area under the receiver operating characteristic curve (aROC). Sensitivity, specificity, positive and negative predictive values were also calculated. RESULTS: Of the 1023 CFPs included in the study, 226 images were of AMD and 797 images were of other ocular conditions or no abnormal findings. Participating community optometrists had a mean (SD) age of 30.2 (8.9) years, 60.0% (3/5) were female and the mean number of years practising in primary eye care was 5.4 (5.4) years. Community optometrists demonstrated excellent performance for diagnosing AMD, with an aROC of 0.86 (95% CI 0.83 to 0.89), sensitivity of 84.5% (95% CI 79.1 to 89.0) and specificity of 88.0% (95% CI 85.5 to 90.1). The aROC (95% CI) for diagnosing early, intermediate, late geographic atrophy and late neovascular AMD was 0.82 (0.73 to 0.91), 0.76 (0.72 to 0.81), 0.69 (0.49 to 0.90) and 0.55 (0.34 to 0.75), respectively. CONCLUSIONS: These results justify the need for an appropriately powered definitive study to assess community clinicians' diagnostic accuracy for AMD.


Asunto(s)
Atrofia Geográfica , Optometristas , Degeneración Macular Húmeda , Humanos , Femenino , Adulto , Masculino , Proyectos Piloto , Atrofia Geográfica/diagnóstico , Inhibidores de la Angiogénesis , Color , Agudeza Visual , Factor A de Crecimiento Endotelial Vascular
4.
BMC Pulm Med ; 23(1): 343, 2023 Sep 13.
Artículo en Inglés | MEDLINE | ID: mdl-37700263

RESUMEN

BACKGROUND: Diaphragmatic dysfunction is known to be associated with difficulties weaning from invasive mechanical ventilation and is related to worse patient outcomes yet our understanding of how to prevent diaphragmatic dysfunction remains incomplete. We examined potentially modifiable risk factors for diaphragmatic dysfunction and attempted to estimate benefits attributable to altering these modifiable risk factors. METHODS: This prospective multicenter observational study was undertaken in the general ICUs of two tertiary care teaching hospitals. Critically ill adults expected to receive invasive mechanical ventilation for at least 48 h were enrolled. Diaphragm function was assessed by ultrasound each study day, with dysfunction defined as thickening fraction less than 20%. RESULTS: From January to December 2019, 856 patients were screened and 126 patients were enrolled. Overall, 40.5% (51/126) of patients experienced diaphragmatic dysfunction during invasive mechanical ventilation. Patients with diaphragmatic dysfunction were more likely to develop ventilator associated pneumonia (risk difference [RD] + 12.9%, 95% Confidence Interval [CI] 1.4 to 24.4%, P = 0.028), were more likely to experience extubation failure (RD + 8.5%, 95% CI 0.4 to 16.6%, P = 0.039) and required a longer duration of invasive mechanical ventilation (RD + 1.3 days, 95% CI 0.1 to 2.5 days, P = 0.035). They also required a longer hospital stay (RD + 1.2 days, 95% CI 0.04 to 2.4 days, P = 0.041) and were more likely to die before hospital discharge (RD + 18.1%, 95% CI 3.7 to 32.5%, P = 0.014). Multivariable analysis considered the impact of age, sex, pre-existing nutritional status, caloric intake, amino acid intake, acute disease severity, modes of mechanical ventilation, measures of respiratory status, sedation, pain control and baseline diaphragm thickness. Only SOFA score (P = 0.008) and early amino acid intake (P = 0.001) remained significant independent risk factors for the onset of diaphragmatic dysfunction. Causal path modeling suggested early amino acid intake may significantly reduce diaphragmatic dysfunction (RRR 29%, 95% CI 10% to 48%, P = 0.003) and may also reduce mortality (RRR 49%, 95% CI 25% to 73%, P < 0.0001). CONCLUSIONS: Amino acid intake during the first 24 h of ICU stay may represent an important, modifiable risk factor for diaphragmatic dysfunction and may have a direct causal effect on mortality. We recommend additional research on this topic.


Asunto(s)
Diafragma , Ventiladores Mecánicos , Adulto , Humanos , Diafragma/diagnóstico por imagen , Estudios Prospectivos , Factores de Riesgo , Aminoácidos
5.
Eye (Lond) ; 37(1): 21-29, 2023 01.
Artículo en Inglés | MEDLINE | ID: mdl-36456704

RESUMEN

BACKGROUND/OBJECTIVES: The purpose of this project was to systematically review and meta-analyse studies assessing the diagnostic accuracy of optical coherence tomography angiography (OCTA) and optical coherence tomography (OCT) for myopic choroidal neovascularisation (mCNV). Fluorescein angiography (FA) was accepted as the reference standard. METHODS: PUBMED and EMBASE were searched from inception to March 2021 for studies evaluating the test accuracy of OCTA and/or OCT for diagnosing mCNV. The Preferred Reporting Items for Systematic Reviews and Meta-analyses of Diagnostic Test Accuracy Studies guideline was followed, and the Grading of Recommendations, Assessment, Development and Evaluation approach was used to frame clinical recommendations. Pooled estimates of test accuracy were obtained using a bivariate model. RESULTS: Of 410 studies assessed for eligibility, 3 studies were identified that compared OCTA to FA and 3 studies were identified that compared spectral domain (SD) OCT to FA. All studies had at least one major methodological flaw leading to an overall high risk of bias. On meta-analysis, the pooled sensitivity of OCTA was 0.89 (95% CI 0.78-0.94) and pooled specificity was 0.93 (95% CI 0.79-0.98). The pooled sensitivity of SD-OCT was 0.99 (95% CI 0.91-1.00). Due to uncertainty in individual studies, the pooled specificity of SD-OCT could not be estimated. CONCLUSIONS: OCTA can reliably diagnose mCNV in clinically suspected patients, however, SD-OCT may not reliably establish a positive diagnosis of mCNV. Future large, prospective studies with improvements in conduct and reporting are needed to strengthen these clinical recommendations.


Asunto(s)
Neovascularización Coroidal , Tomografía de Coherencia Óptica , Humanos , Tomografía de Coherencia Óptica/métodos , Estudios Prospectivos , Neovascularización Coroidal/diagnóstico , Angiografía con Fluoresceína/métodos
6.
Ophthalmic Physiol Opt ; 42(6): 1170-1179, 2022 11.
Artículo en Inglés | MEDLINE | ID: mdl-35924658

RESUMEN

PURPOSE: Artificial intelligence (AI)-based systems have demonstrated great potential in improving the diagnostic accuracy of retinal disease but are yet to achieve widespread acceptance in routine clinical practice. Clinician attitudes are known to influence implementation. Therefore, this study aimed to identify optometrists' attitudes towards the use of AI to assist in diagnosing retinal disease. METHODS: A paper-based survey was designed to assess general attitudes towards AI in diagnosing retinal disease and motivators/barriers for future use. Two clinical scenarios for using AI were evaluated: (1) at the point of care to obtain a diagnostic recommendation, versus (2) after the consultation to provide a second opinion. Relationships between participant characteristics and attitudes towards AI were explored. The survey was mailed to 252 randomly selected practising optometrists across Australia, with repeat mail-outs to non-respondents. RESULTS: The response rate was 53% (133/252). Respondents' mean (SD) age was 42.7 (13.3) years, and 44.4% (59/133) identified as female, whilst 1.5% (2/133) identified as gender diverse. The mean number of years practising in primary eye care was 18.8 (13.2) years with 64.7% (86/133) working in an independently owned practice. On average, responding optometrists reported positive attitudes (mean score 4.0 out of 5, SD 0.8) towards using AI as a tool to aid the diagnosis of retinal disease, and would be more likely to use AI if it is proven to increase patient access to healthcare (mean score 4.4 out of 5, SD 0.6). Furthermore, optometrists expressed a statistically significant preference for using AI after the consultation to provide a second opinion rather than during the consultation, at the point-of-care (+0.12, p = 0.01). CONCLUSIONS: Optometrists have positive attitudes towards the future use of AI as an aid to diagnose retinal disease. Understanding clinician attitudes and preferences for using AI may help maximise its clinical potential and ensure its successful translation into practice.


Asunto(s)
Optometristas , Optometría , Enfermedades de la Retina , Adulto , Inteligencia Artificial , Estudios Transversales , Femenino , Humanos , Masculino , Persona de Mediana Edad , Servicios Postales , Enfermedades de la Retina/diagnóstico
7.
Intensive Care Med ; 48(7): 899-909, 2022 07.
Artículo en Inglés | MEDLINE | ID: mdl-35713670

RESUMEN

PURPOSE: Infected pancreatic necrosis (IPN) is a highly morbid complication of acute necrotising pancreatitis (ANP). Since there is evidence of early-onset immunosuppression in acute pancreatitis, immune enhancement may be a therapeutic option. This trial aimed to evaluate whether early immune-enhancing Thymosin alpha 1 (Tα1) treatment reduces the incidence of IPN in patients with predicted severe ANP. METHODS: We conducted a multicentre, double-blind, randomised, placebo-controlled trial involving ANP patients with an Acute Physiology and Chronic Health Evaluation II (APACHE II) score ≥ 8 and a computed tomography (CT) severity score ≥ 5 admitted within 7 days of the advent of symptoms. Enrolled patients were assigned to receive a subcutaneous injection of Tα1 1.6 mg every 12 h for the first 7 days and 1.6 mg once a day for the subsequent 7 days or matching placebos (normal saline). The primary outcome was the development of IPN during the index admission. RESULTS: A total of 508 patients were randomised, of whom 254 were assigned to receive Tα1 and 254 placebo. The vast majority of the participants required admission to the intensive care unit (ICU) (479/508, 94.3%). During the index admission, 40/254(15.7%) patients in the Tα1 group developed IPN compared with 46/254 patients (18.1%) in the placebo group (difference -2.4% [95% CI - 7.4 to 5.1%]; p = 0.48). The results were similar across four predefined subgroups. There was no difference in other major complications, including new-onset organ failure (10.6% vs. 15%), bleeding (6.3% vs. 3.5%), and gastrointestinal fistula (2% vs. 2.4%). CONCLUSION: The immune-enhancing Tα1 treatment of patients with predicted severe ANP did not reduce the incidence of IPN during the index admission.


Asunto(s)
Pancreatitis Aguda Necrotizante , Humanos , Enfermedad Aguda , Método Doble Ciego , Pancreatitis Aguda Necrotizante/complicaciones , Pancreatitis Aguda Necrotizante/diagnóstico por imagen , Resultado del Tratamiento
9.
Crit Care ; 26(1): 46, 2022 02 16.
Artículo en Inglés | MEDLINE | ID: mdl-35172856

RESUMEN

BACKGROUND: Previous cluster-randomized controlled trials evaluating the impact of implementing evidence-based guidelines for nutrition therapy in critical illness do not consistently demonstrate patient benefits. A large-scale, sufficiently powered study is therefore warranted to ascertain the effects of guideline implementation on patient-centered outcomes. METHODS: We conducted a multicenter, cluster-randomized, parallel-controlled trial in intensive care units (ICUs) across China. We developed an evidence-based feeding guideline. ICUs randomly allocated to the guideline group formed a local "intervention team", which actively implemented the guideline using standardized educational materials, a graphical feeding protocol, and live online education outreach meetings conducted by members of the study management committee. ICUs assigned to the control group remained unaware of the guideline content. All ICUs enrolled patients who were expected to stay in the ICU longer than seven days. The primary outcome was all-cause mortality within 28 days of enrollment. RESULTS: Forty-eight ICUs were randomized to the guideline group and 49 to the control group. From March 2018 to July 2019, the guideline ICUs enrolled 1399 patients, and the control ICUs enrolled 1373 patients. Implementation of the guideline resulted in significantly earlier EN initiation (1.20 vs. 1.55 mean days to initiation of EN; difference - 0.40 [95% CI - 0.71 to - 0.09]; P = 0.01) and delayed PN initiation (1.29 vs. 0.80 mean days to start of PN; difference 1.06 [95% CI 0.44 to 1.67]; P = 0.001). There was no significant difference in 28-day mortality (14.2% vs. 15.2%; difference - 1.6% [95% CI - 4.3% to 1.2%]; P = 0.42) between groups. CONCLUSIONS: In this large-scale, multicenter trial, active implementation of an evidence-based feeding guideline reduced the time to commencement of EN and overall PN use but did not translate to a reduction in mortality from critical illness. TRIAL REGISTRATION: ISRCTN, ISRCTN12233792 . Registered November 20th, 2017.


Asunto(s)
Enfermedad Crítica , Apoyo Nutricional , China , Enfermedad Crítica/terapia , Humanos , Unidades de Cuidados Intensivos , Factores de Tiempo
10.
Front Med (Lausanne) ; 8: 731955, 2021.
Artículo en Inglés | MEDLINE | ID: mdl-34671619

RESUMEN

Introduction/aim: The supraphysiologic chloride concentration of normal saline may contribute to acute kidney injury (AKI). Balanced crystalloids can decrease chloride concentration and AKI in critically ill patients. We aim to test the hypothesis that, in patients with predicted severe acute pancreatitis (pSAP), compared with saline, fluid therapy with balanced crystalloids will decrease plasma chloride concentration. Methods/Design: This is a multicenter, stepped-wedge, cluster-randomized, controlled trial. All eligible patients presenting to the 11 participating sites across China during the study period will be recruited. All sites will use saline for the first month and sequentially change to balanced crystalloids at the pre-determined and randomly allocated time point. The primary endpoint is the plasma chloride concentration on day 3 of enrollment. Secondary endpoints will include major adverse kidney events on hospital discharge or day 30 (MAKE 30) and free and alive days to day 30 for intensive care admission, invasive ventilation, vasopressors, and renal replacement therapy. Additional endpoints include daily serum chloride and sequential organ failure assessment (SOFA) score over the first seven days of enrollment. Discussion: This study will provide data to define the impact of normal saline vs. balanced crystalloids on plasma chloride concentration and clinical outcomes in pSAP patients. It will also provide the necessary data to power future large-scale randomized trials relating to fluid therapy. Ethics and Dissemination: This study was approved by the ethics committee of Jinling Hospital, Nanjing University (2020NZKY-015-01) and all the participating sites. The results of this trial will be disseminated in peer-reviewed journals and at scientific conferences. Trial registration: The trial has been registered at the Chinese Clinical Trials Registry (ChiCTR2100044432).

12.
Perioper Med (Lond) ; 10(1): 10, 2021 Mar 23.
Artículo en Inglés | MEDLINE | ID: mdl-33752757

RESUMEN

BACKGROUND: Although current guidelines make consensus recommendations for the early resumption of oral intake after surgery, a recent comprehensive meta-analysis failed to identify any patient-centered benefits. We hypothesized this finding was attributable to pooling studies providing effective protein-containing diets with ineffective non-protein liquid diets. Therefore, the aim of this paper was to investigate the safety and efficacy of early oral protein-containing diets versus later (traditional) feeding after elective lower gastrointestinal tract surgery in adults. METHODS: PubMed, Embase, and the China National Knowledge Infrastructure databases were searched from inception until 1 August 2019. Reference lists of retrieved studies were hand searched to identify randomized clinical trials reporting mortality. No language restrictions were applied. Study selection, risk of bias appraisal and data abstraction were undertaken independently by two authors. Disagreements were settled by obtaining an opinion of a third author. Majority decisions prevailed. After assessment of underlying assumptions, a fixed-effects method was used for analysis. The primary outcome was mortality. Secondary outcomes included surgical site infections, postoperative nausea and vomiting, serious postoperative complications and other key measures of safety and efficacy. RESULTS: Eight randomized clinical trials recruiting 657 patients were included. Compared with later (traditional) feeding, commencing an early oral protein-containing diet resulted in a statistically significant reduction in mortality (odds ratio [OR] 0.31, P = 0.02, I2 = 0%). An early oral protein-containing diet also significantly reduced surgical site infections (OR 0.39, P = 0.002, I2 = 32%), postoperative nausea and vomiting (OR 0.62, P = 0.04, I2 = 37%), serious postoperative complications (OR 0.60, P = 0.01, I2 = 25%), and significantly improved other major outcomes. No harms attributable to an early oral protein-containing diet were identified. CONCLUSIONS: The results of this systematic review can be used to upgrade current guideline statements to a grade A recommendation supporting an oral protein-containing diet commenced before the end of postoperative day 1 after elective lower gastrointestinal surgery in adults.

13.
Asia Pac J Clin Nutr ; 30(1): 15-21, 2021.
Artículo en Inglés | MEDLINE | ID: mdl-33787036

RESUMEN

BACKGROUND AND OBJECTIVES: The novel coronavirus disease (COVID-19) epidemic is spreading all over the world. With the number of cases increasing rapidly, the epidemiological data on the nutritional practice is scarce. In this study, we aim to describe the clinical characteristics and nutritional practice in a cohort of critically ill COVID-19 patients. METHODS AND STUDY DESIGN: This is a multicenter, ambidirectional cohort study conducted at 11 hospitals in Hubei Province, China. All eligible critical COVID-19 patients in the study hospital intensive care units at 00:00, March 6th, 2020, were included. Data collection was performed via written case report forms. RESULTS: A total of 44 patients were identified and enrolled, of whom eight died during the 28-day outcome follow- up period. The median interval between hospital admission and the study day was 24 (interquartile range, 13- 26) days and 52.2% (23 of 44) of patients were on invasive mechanical ventilation. The median nutrition risk in critically ill (mNUTRIC) score was 3 (interquartile range, 2-5) on the study day. During the enrolment day, 68.2% (30 of 44) of patients received enteral nutrition (EN), while 6.8% (3 of 44) received parenteral nutrition (PN) alone. Nausea and aspiration were uncommon, with a prevalence of 11.4% (5 of 44) and 6.8% (3 of 44), respectively. As for energy delivery, 69.7% (23 of 33) of patients receiving EN and/or PN were achieving their prescribed targets. CONCLUSIONS: The study showed that EN was frequently applied in critical COVID-19 patients. Energy delivery may be suboptimal in this study requiring more attention.


Asunto(s)
COVID-19/epidemiología , COVID-19/terapia , Enfermedad Crítica/epidemiología , Estado Nutricional , Apoyo Nutricional , Anciano , China/epidemiología , Estudios de Cohortes , Nutrición Enteral/estadística & datos numéricos , Femenino , Hospitalización , Humanos , Unidades de Cuidados Intensivos , Masculino , Persona de Mediana Edad , Nutrición Parenteral/estadística & datos numéricos , SARS-CoV-2
14.
J Hepatobiliary Pancreat Sci ; 28(4): 387-396, 2021 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-33595879

RESUMEN

BACKGROUND/PURPOSE: The current standard care for acute pancreatitis with acute necrotic collections (ANC) is to postpone invasive intervention for 4 weeks when indicated. However, in patients with persistent organ failure (POF), this delayed approach may prolong organ failure. In this study, we aimed to assess the feasibility and safety of earlier drainage for acute pancreatitis patients with ANC and POF. METHODS: A single-center, randomized controlled trial was conducted. Eligible patients were randomly assigned to either the early on-demand (EOD) group or the standard management (SM) group. Within 21 days of randomization, early drainage was triggered by unremitted or worsening organ failure in the EOD group. The primary endpoint was a composite of major complications/death during 90-days follow-up. RESULTS: Thirty patients were randomized. Within 21 days of randomization, eight of the 15 patients (53%) in the EOD group underwent percutaneous drainage compared to four of the 15 patients (27%) in the SM group (P = 0.26). The primary outcome occurred in three of the 15 (20%) patients in the EOD group and seven of the 15(46.7%) in the controls (P = 0.25, relative risk 0.43, 95%CI 0.14 to 1.35). CONCLUSIONS: Although the EOD approach did not result in significant differences between groups, the primary outcome assessed in this trial demonstrated the potential for clinical benefits favoring early drainage.


Asunto(s)
Pancreatitis Aguda Necrotizante , Enfermedad Aguda , Drenaje , Humanos , Pancreatitis Aguda Necrotizante/terapia , Proyectos Piloto , Resultado del Tratamiento
15.
Lancet Respir Med ; 9(4): 360-372, 2021 04.
Artículo en Inglés | MEDLINE | ID: mdl-33493448

RESUMEN

BACKGROUND: Mechanical ventilation in intensive care for 48 h or longer is associated with the acute respiratory distress syndrome (ARDS), which might be present at the time ventilatory support is instituted or develop afterwards, predominantly during the first 5 days. Survivors of prolonged mechanical ventilation and ARDS are at risk of considerably impaired physical function that can persist for years. An early pathogenic mechanism of lung injury in mechanically ventilated, critically ill patients is inflammation-induced pulmonary fibrin deposition, leading to thrombosis of the microvasculature and hyaline membrane formation in the air sacs. The main aim of this study was to determine if nebulised heparin, which targets fibrin deposition, would limit lung injury and thereby accelerate recovery of physical function in patients with or at risk of ARDS. METHODS: The Can Heparin Administration Reduce Lung Injury (CHARLI) study was an investigator-initiated, multicentre, double-blind, randomised phase 3 trial across nine hospitals in Australia. Adult intensive care patients on invasive ventilation, with impaired oxygenation defined by a PaO2/FiO2 ratio of less than 300, and with the expectation of invasive ventilation beyond the next calendar day were recruited. Key exclusion criteria were heparin allergy, pulmonary bleeding, and platelet count less than 50 X 109/L. Patients were randomly assigned 1:1, with stratification by site and using blocks of variable size and random seed, via a web-based system, to either unfractionated heparin sodium 25 000 IU in 5 mL or identical placebo (sodium chloride 0·9% 5 mL), administered using a vibrating mesh membrane nebuliser every 6 h to day 10 while invasively ventilated. Patients, clinicians, and investigators were masked to treatment allocation. The primary outcome was the Short Form 36 Health Survey Physical Function Score (out of 100) of survivors at day 60. Prespecified secondary outcomes, which are exploratory, included development of ARDS to day 5 among at-risk patients, deterioration of the Murray Lung Injury Score (MLIS) to day 5, mortality at day 60, residence of survivors at day 60, and serious adverse events. Analyses followed the intention-to-treat principle. There was no imputation of missing data. The trial is registered with the Australian and New Zealand Clinical Trials Register, number ACTRN12612000418875 . FINDINGS: Between Sept 4, 2012, and Aug 23, 2018, 256 patients were randomised. Final follow-up was on Feb 25, 2019. We excluded three patients who revoked consent and one ineligible participant who received no intervention. Of 252 patients included in data analysis, the mean age was 58 years (SD 15), 157 (62%) were men, and 118 (47%) had ARDS. 128 (51%) patients were assigned to the heparin group and 124 (49%) to the placebo group, all of whom received their assigned intervention. Survivors in the heparin group (n=97) had similar SF-36 Physical Function Scores at day 60 compared to the placebo group (n=94; mean 53·6 [SD 31·6] vs 48·7 [35·7]; difference 4·9 [95% CI -4·8 to 14·5]; p=0·32). Compared with the placebo group, the heparin group had fewer cases of ARDS develop to day 5 among the at-risk patients (nine [15%] of 62 patients vs 21 [30%] of 71 patients; hazard ratio 0·46 [95% CI 0·22 to 0·98]; p=0·0431), less deterioration of the MLIS to day 5 (difference -0·14 [-0·26 to -0·02]; p=0·0215), similar day 60 mortality (23 [18%] of 127 patients vs 18 [15%] of 123 patients; odds ratio [OR] 1·29 [95% CI 0·66 to 2·53]; p=0·46), and more day 60 survivors at home (86 [87%] of 99 patients vs 73 [73%] of 100 patients; OR 2·45 [1·18 to 5·08]; p=0·0165). A similar number of serious adverse events occurred in each group (seven [5%] of 128 patients in the heparin group vs three [2%] of 124 patients in the placebo group; OR 2·33 [0·59 to 9·24]; p=0·23), which were a transient increase in airway pressure during nebulisation (n=3 in the heparin group), major non-pulmonary bleeding (n=2 in each group), haemoptysis (n=1 in the heparin group), tracheotomy site bleeding (n=1 in the heparin group), and hypoxaemia during nebulisation (n=1 in the placebo group). INTERPRETATION: In patients with or at risk of ARDS, nebulised heparin did not improve self-reported performance of daily physical activities, but was well tolerated and exploratory outcomes suggest less progression of lung injury and earlier return home. Further research is justified to establish if nebulised heparin accelerates recovery in those who have or are at risk of ARDS. FUNDING: Rowe Family Foundation, TR and RB Ditchfield Medical Research Endowment Fund, Patricia Madigan Charitable Trust, and The J and R McGauran Trust Fund.


Asunto(s)
Cuidados Críticos/métodos , Heparina/administración & dosificación , Respiración Artificial/efectos adversos , Síndrome de Dificultad Respiratoria/epidemiología , Actividades Cotidianas , Administración por Inhalación , Adulto , Anciano , Australia/epidemiología , Método Doble Ciego , Femenino , Hemoptisis/inducido químicamente , Hemoptisis/epidemiología , Heparina/efectos adversos , Mortalidad Hospitalaria , Humanos , Hipoxia/inducido químicamente , Hipoxia/epidemiología , Incidencia , Masculino , Persona de Mediana Edad , Nebulizadores y Vaporizadores , Placebos/administración & dosificación , Placebos/efectos adversos , Síndrome de Dificultad Respiratoria/diagnóstico , Síndrome de Dificultad Respiratoria/etiología , Síndrome de Dificultad Respiratoria/prevención & control , Autoinforme/estadística & datos numéricos , Índice de Severidad de la Enfermedad , Sobrevivientes/estadística & datos numéricos , Factores de Tiempo , Resultado del Tratamiento
19.
J Crit Care ; 55: 9-15, 2020 02.
Artículo en Inglés | MEDLINE | ID: mdl-31670150

RESUMEN

PURPOSE: Evidence summary resources are popular with clinicians but it is unknown whether they can influence clinical decision making. We evaluated whether an extremely condensed and explicit evidence summary tool could influence clinical decision making. MATERIALS AND METHODS: An evidence summary tool was developed using a formal mapping exercise and graphic design principles. An invitation to participate was sent to subscribers of a critical care e-mail discussion list. Participants received a study package (evidence summary tool précising prone positioning in severe ARDS; case-based scenario describing a patient with severe ARDS plus evaluation questionnaire). Influence on clinical decisions was captured regarding six competing interventions, with Belief in benefit measured before and after reading the summary tool. RESULTS: Among 93 participants, 87% were male with a mean age of 49.6(SD9.3) years. Mean ICU experience was 20.0(SD9.9) years. The evidence summary tool significantly influenced clinical decision making: belief in benefit of prone positioning increased (P < .001), belief in benefit of higher PEEP decreased (P = .002) and belief in benefit in ECMO decreased (P = .07). CONCLUSIONS: Using a before-after evaluation, we demonstrated an extremely condensed and explicit information format can influence clinical decision making. Evidence summary tools may be a useful adjunct to support closing evidence-practice gaps.


Asunto(s)
Toma de Decisiones Clínicas , Cuidados Críticos , Síndrome de Dificultad Respiratoria/terapia , Medicina Basada en la Evidencia , Femenino , Humanos , Unidades de Cuidados Intensivos , Masculino , Persona de Mediana Edad , Encuestas y Cuestionarios
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