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1.
Acta Anaesthesiol Scand ; 68(10): 1601-1606, 2024 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-39350471

RESUMO

BACKGROUND: Feeding intolerance is common in critically ill patients and can lead to malnutrition. Prokinetic agents may be used to enhance the uptake of nutrition. However, the evidence on the effectiveness and safety of prokinetic agents is sparse, and there is a lack of data on their use in intensive care units (ICU). METHODS: We will conduct an international 14-day inception cohort study of 1000 acutely admitted adult ICU patients. Data will be collected from ICU admission and daily during ICU stay for up to 90 days. The primary outcome will be the proportion of ICU patients who receive prokinetic agents. Secondary outcomes include mortality, days alive without life support, days alive out of ICU, days alive out of hospital (all within 90 days) and the number of patients with one or more serious adverse events. RESULTS: We will present data on the use of prokinetic agents descriptively and use Cox regressions with death and ICU discharge as competing events to evaluate the association between patient characteristics and the use of prokinetic agents. We will use extended Cox models with time-varying covariates and linear regression models to assess the associations between the use of prokinetic agents and the secondary outcomes. CONCLUSION: The outlined international cohort study will provide valuable epidemiological data on the use of prokinetic agents in adult, acutely admitted ICU patients.


Assuntos
Fármacos Gastrointestinais , Unidades de Terapia Intensiva , Humanos , Estudos de Coortes , Adulto , Fármacos Gastrointestinais/uso terapêutico , Estado Terminal , Cuidados Críticos/métodos
2.
Acta Anaesthesiol Scand ; 68(10): 1549-1555, 2024 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-38981497

RESUMO

BACKGROUND: Nosocomial infections contribute significantly to mortality and morbidity in burn patients. Selective decontamination of the digestive tract is an infection prevention measure that has been shown to improve survival in mechanically ventilated intensive care unit (ICU) patients. It has been hypothesized that burn patients may benefit from selective decontamination of the digestive tract. METHODS/DESIGN: We will conduct a systematic review with meta-analysis and trial sequential analysis of randomized clinical trials (RCTs) assessing the patient-important effects of selective decontamination of the digestive tract in burn patients, as compared with placebo or no intervention/standard of care. The primary outcome will be 30-day mortality. Secondary outcomes include serious adverse events, anti-microbial resistance, pneumonia, blood stream infections, ICU- and hospital-free days and 90-day mortality. We will search the following databases: CENTRAL, MEDLINE, EMBASE, BIOSIS, Web of Science and CINAHL and follow the recommendations provided by the Cochrane Collaboration and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. The certainty of evidence will be assessed according to the GRADE approach: Grading of Recommendations Assessment, Development and Evaluation. DISCUSSION: There is clinical equipoise about the use of selective decontamination of the digestive tract in burn patients. In the outlined systematic review and meta-analysis, we will assess the desirable and undesirable effects of selective decontamination of the digestive tract in burn patients.


Assuntos
Queimaduras , Descontaminação , Trato Gastrointestinal , Revisões Sistemáticas como Assunto , Humanos , Queimaduras/complicações , Descontaminação/métodos , Trato Gastrointestinal/microbiologia , Ensaios Clínicos Controlados Aleatórios como Assunto , Infecção Hospitalar/prevenção & controle
3.
Artigo em Inglês | MEDLINE | ID: mdl-38965670

RESUMO

BACKGROUND: Perioperative hypotension is common and associated with adverse patient outcomes. Vasoactive agents are often used to manage hypotension, but the ideal drug, dose and duration of treatment has not been established. With this scoping review, we aim to provide an overview of the current body of evidence regarding the vasoactive agents used to treat perioperative hypotension in non-cardiac surgery. METHODS: We included all studies describing the use of vasoactive agents for the treatment of perioperative hypotension in non-cardiac surgery. We excluded literature reviews, case studies, and studies on animals and healthy subjects. We posed the following research questions: (1) in which surgical populations have vasoactive agents been studied? (2) which agents have been studied? (3) what doses have been assessed? (4) what is the duration of treatment? and (5) which desirable and undesirable outcomes have been assessed? RESULTS: We included 124 studies representing 10 surgical specialties. Eighteen different agents were evaluated, predominantly phenylephrine, ephedrine, and noradrenaline. The agents were administered through six different routes, and numerous comparisons between agents, dosages and routes were included. Then, 88 distinct outcome measures were assessed, of which 54 were judged to be non-patient-centred. CONCLUSIONS: We found that studies concerning vasoactive agents for the treatment of perioperative hypotension varied considerably in all aspects. Populations were heterogeneous, interventions and exposures included multiple agents compared against themselves, each other, fluids or placebo, and studies reported primarily non-patient-centred outcomes.

4.
Acta Anaesthesiol Scand ; 68(8): 1018-1030, 2024 09.
Artigo em Inglês | MEDLINE | ID: mdl-38840310

RESUMO

BACKGROUND: Platelet transfusions are frequently used in the intensive care unit (ICU), but current practices including used product types, volumes, doses and effects are unknown. STUDY DESIGN AND METHODS: Sub-study of the inception cohort study 'Thrombocytopenia and Platelet Transfusions in the ICU (PLOT-ICU)', including acutely admitted, adult ICU patients with thrombocytopenia (platelet count <150 × 109/L). The primary outcome was the number of patients receiving platelet transfusion in ICU by product type. Secondary outcomes included platelet transfusion details, platelet increments, bleeding, other transfusions and mortality. RESULTS: Amongst 504 patients with thrombocytopenia from 43 hospitals in 10 countries in Europe and the United States, 20.8% received 565 platelet transfusions; 61.0% received pooled products, 21.9% received apheresis products and 17.1% received both with a median of 2 (interquartile range 1-4) days from admission to first transfusion. The median volume per transfusion was 253 mL (180-308 mL) and pooled products accounted for 59.1% of transfusions, however, this varied across countries. Most centres (73.8%) used fixed dosing (medians ranging from 2.0 to 3.5 × 1011 platelets/transfusion) whilst some (mainly in France) used weight-based dosing (ranging from 0.5 to 0.7 × 1011 platelets per 10 kg body weight). The median platelet count increment for a single prophylactic platelet transfusion was 2 (-1 to 8) × 109/L. Outcomes of patients with thrombocytopenia who did and did not receive platelet transfusions varied. CONCLUSIONS: Among acutely admitted, adult ICU patients with thrombocytopenia, 20.8% received platelet transfusions in ICU of whom most received pooled products, but considerable variation was observed in product type, volumes and doses across countries. Prophylactic platelet transfusions were associated with limited increases in platelet counts.


Assuntos
Unidades de Terapia Intensiva , Transfusão de Plaquetas , Trombocitopenia , Humanos , Transfusão de Plaquetas/estatística & dados numéricos , Trombocitopenia/terapia , Feminino , Masculino , Estudos de Coortes , Pessoa de Meia-Idade , Idoso , Europa (Continente) , Adulto , Cuidados Críticos/métodos
5.
Artigo em Inglês | MEDLINE | ID: mdl-38867404

RESUMO

BACKGROUND: Enteral nutrition may affect risks of gastrointestinal bleeding, pneumonia and mortality in critically ill patients and may also modify the effects of pharmacological stress ulcer prophylaxis. We undertook post hoc analyses of the stress ulcer prophylaxis in the intensive care unit trial to assess for any associations and interactions between enteral nutrition and pantoprazole. METHODS: Extended Cox models with time-varying co-variates and competing events were used to assess potential associations, adjusted for baseline severity of illness. Potential interactions between daily enteral nutrition and allocation to pantoprazole on outcomes were similarly assessed. RESULTS: Enteral nutrition was associated with lower risk of clinically important gastrointestinal bleeding (cause-specific hazard ratio [HR]: 0.29, 95% confidence interval: [CI] 0.19-0.44, p < .001), higher risk of pneumonia (HR: 1.44, 95% CI: 1.14-1.82, p = .003), and lower risk of all-cause mortality (HR: 0.22, 95% CI: 0.18-0.27, p < .001). Enteral nutrition with allocation to pantoprazole was associated with a lower risk of mortality (HR: 0.27, 95% CI: 0.21-0.35, p < .001), similar to enteral nutrition with allocation to placebo (HR: 0.17, 95% CI: 0.13-0.23, p < .001). Allocation to pantoprazole with no enteral nutrition had little effect on mortality (HR: 0.83, 95% CI: 0.63-1.09, p = .179), whilst allocation to pantoprazole and receipt of enteral nutrition was mostly compatible with increased all-cause mortality (HR: 1.27, 95% CI: 0.99-1.64, p = .061). The test of interaction between enteral nutrition and pantoprazole treatment allocation for all-cause mortality was statistically significant (p = .024). CONCLUSIONS: Enteral nutrition was associated with an increased risk of pneumonia and a reduced risk of gastrointestinal bleeding. The interaction between pantoprazole and enteral nutrition suggesting an increased risk of mortality requires further study.

6.
NEJM Evid ; 3(7): EVIDoa2400134, 2024 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-38874580

RESUMO

BACKGROUND: The goal of this systematic review was to examine the efficacy and safety of proton-pump inhibitors for stress ulcer prophylaxis in critically ill patients. METHODS: We included randomized trials comparing proton-pump inhibitors versus placebo or no prophylaxis in critically ill adults, performed meta-analyses, and assessed certainty of evidence using the Grading of Recommendations, Assessment, Development, and Evaluations approach. To explore the effect of proton-pump inhibitors on mortality based on disease severity, a subgroup analysis was conducted combining within-trial subgroup data from the two largest trials and assessed credibility using the Instrument for Assessing the Credibility of Effect Modification Analyses. RESULTS: Twelve trials that enrolled 9533 patients were included. Proton-pump inhibitors were associated with a reduced incidence of clinically important upper gastrointestinal bleeding (relative risk [RR], 0.51 [95% confidence interval (CI), 0.34 to 0.76]; high certainty evidence). Proton-pump inhibitors may have little or no effect on mortality (RR, 0.99 [95% CI, 0.93 to 1.05]; low certainty). Within-trial subgroup analysis with intermediate credibility suggested that the effect of proton-pump inhibitors on mortality may differ based on disease severity. Subgroup results raise the possibility that proton-pump inhibitors may decrease 90-day mortality in less severely ill patients (RR, 0.89; 95% CI, 0.80 to 0.98) and may increase mortality in more severely ill patients (RR, 1.08; 95% CI, 0.96 to 1.20]. Proton-pump inhibitors may have no effect on pneumonia and little or no effect on Clostridioides difficile infection (low certainty). CONCLUSIONS: High certainty evidence supports the association of proton-pump inhibitors with decreased upper gastrointestinal bleeding. Proton-pump inhibitors may have little or no effect on mortality, although a decrease in mortality in less severely ill patients and an increase in mortality in more severely ill patients remain possible. (PROSPERO number CRD42023461695.).


Assuntos
Estado Terminal , Hemorragia Gastrointestinal , Inibidores da Bomba de Prótons , Humanos , Inibidores da Bomba de Prótons/uso terapêutico , Inibidores da Bomba de Prótons/efeitos adversos , Inibidores da Bomba de Prótons/administração & dosagem , Hemorragia Gastrointestinal/prevenção & controle , Hemorragia Gastrointestinal/induzido quimicamente , Ensaios Clínicos Controlados Aleatórios como Assunto
7.
Acta Anaesthesiol Scand ; 68(7): 983-988, 2024 08.
Artigo em Inglês | MEDLINE | ID: mdl-38581102

RESUMO

BACKGROUND: Proton pump inhibitors (PPIs) are the most commonly prescribed drugs for preventing upper gastrointestinal bleeding in critically ill patients. However, concerns have arisen about the possible harms of using PPIs, including potentially increased risk of pneumonia, Clostridioides difficile infection, and more seriously, an increased risk of death in the most severely ill patients. Triggered by the REVISE trial, which is a forthcoming large randomized trial comparing pantoprazole to placebo in invasively mechanically ventilated patients, we will conduct this systematic review to evaluate the efficacy and safety of PPIs versus no prophylaxis for critically ill patients. METHODS: We will systematically search randomized trials that compared gastrointestinal bleeding prophylaxis with PPIs versus placebo or no prophylaxis in adults in the intensive care unit (ICU). Pairs of reviewers will independently screen the literature, and for those eligible trials, extract data and assess risk of bias. We will perform meta-analyses using a random-effects model, and calculate relative risks for dichotomous outcomes and mean differences for continuous outcomes, and the associated 95% confidence intervals. We will conduct subgroup analysis to explore whether the impact of PPIs on mortality differs in more and less severely ill patients. We will assess certainty of evidence using the GRADE approach. DISCUSSION: This systematic review will provide the most up-to-date evidence regarding the merits and limitations of stress ulcer prophylaxis with PPIs in critically ill patients in contemporary practice.


Assuntos
Estado Terminal , Hemorragia Gastrointestinal , Inibidores da Bomba de Prótons , Revisões Sistemáticas como Assunto , Humanos , Inibidores da Bomba de Prótons/uso terapêutico , Hemorragia Gastrointestinal/prevenção & controle , Hemorragia Gastrointestinal/induzido quimicamente , Ensaios Clínicos Controlados Aleatórios como Assunto
9.
Intensive Care Med ; 49(11): 1327-1338, 2023 11.
Artigo em Inglês | MEDLINE | ID: mdl-37812225

RESUMO

PURPOSE: Thrombocytopenia (platelet count < 150 × 109/L) is common in intensive care unit (ICU) patients and is likely associated with worse outcomes. In this study we present international contemporary data on thrombocytopenia in ICU patients. METHODS: We conducted a prospective cohort study in adult ICU patients in 52 ICUs across 10 countries. We assessed frequencies of thrombocytopenia, use of platelet transfusions and clinical outcomes including mortality. We evaluated pre-selected potential risk factors for the development of thrombocytopenia during ICU stay and associations between thrombocytopenia at ICU admission and 90-day mortality using pre-specified logistic regression analyses. RESULTS: We analysed 1166 ICU patients; the median age was 63 years and 39.5% were female. Overall, 43.2% (95% confidence interval (CI) 40.4-46.1) had thrombocytopenia; 23.4% (20-26) had thrombocytopenia at ICU admission, and 19.8% (17.6-22.2) developed thrombocytopenia during their ICU stay. Absence of acquired immune deficiency syndrome (AIDS), non-cancer-related immune deficiency, liver failure, male sex, septic shock, and bleeding at ICU admission were associated with the development of thrombocytopenia during ICU stay. Among patients with thrombocytopenia, 22.6% received platelet transfusion(s), and 64.3% of in-ICU transfusions were prophylactic. Patients with thrombocytopenia had higher occurrences of bleeding and death, fewer days alive without the use of life-support, and fewer days alive and out of hospital. Thrombocytopenia at ICU admission was associated with 90-day mortality (adjusted odds ratio 1.7; 95% CI 1.19-2.42). CONCLUSION: Thrombocytopenia occurred in 43% of critically ill patients and was associated with worse outcomes including increased mortality. Platelet transfusions were given to 23% of patients with thrombocytopenia and most were prophylactic.


Assuntos
Transfusão de Plaquetas , Trombocitopenia , Adulto , Humanos , Masculino , Feminino , Pessoa de Meia-Idade , Transfusão de Plaquetas/efeitos adversos , Estudos de Coortes , Estudos Prospectivos , Trombocitopenia/epidemiologia , Trombocitopenia/etiologia , Unidades de Terapia Intensiva , Hemorragia/etiologia , Estudos Retrospectivos
10.
Acta Anaesthesiol Scand ; 67(10): 1383-1394, 2023 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-37737652

RESUMO

BACKGROUND: When caring for mechanically ventilated adults with acute hypoxaemic respiratory failure (AHRF), clinicians are faced with an uncertain choice between ventilator modes allowing for spontaneous breaths or ventilation fully controlled by the ventilator. The preferences of clinicians managing such patients, and what motivates their choice of ventilator mode, are largely unknown. To better understand how clinicians' preferences may impact the choice of ventilatory support for patients with AHRF, we issued a survey to an international network of intensive care unit (ICU) researchers. METHODS: We distributed an online survey with 32 broadly similar and interlinked questions on how clinicians prioritise spontaneous or controlled ventilation in invasively ventilated patients with AHRF of different severity, and which factors determine their choice. RESULTS: The survey was distributed to 1337 recipients in 12 countries. Of these, 415 (31%) completed the survey either fully (52%) or partially (48%). Most respondents were identified as medical specialists (87%) or physicians in training (11%). Modes allowing for spontaneous ventilation were considered preferable in mild AHRF, with controlled ventilation considered as progressively more important in moderate and severe AHRF. Among respondents there was strong support (90%) for a randomised clinical trial comparing spontaneous with controlled ventilation in patients with moderate AHRF. CONCLUSIONS: The responses from this international survey suggest that there is clinical equipoise for the preferred ventilator mode in patients with AHRF of moderate severity. We found strong support for a randomised trial comparing modes of ventilation in patients with moderate AHRF.


Assuntos
Insuficiência Respiratória , Adulto , Humanos , Insuficiência Respiratória/terapia , Respiração Artificial , Pulmão , Unidades de Terapia Intensiva , Respiração
11.
Intensive Care Med ; 49(7): 820-830, 2023 07.
Artigo em Inglês | MEDLINE | ID: mdl-37330928

RESUMO

PURPOSE: To assess long-term outcomes of restrictive versus standard intravenous (IV) fluid therapy in adult intensive care unit (ICU) patients with septic shock included in the European Conservative versus Liberal Approach to Fluid Therapy in Septic Shock in Intensive Care (CLASSIC) trial. METHODS: We conducted the pre-planned analyses of mortality, health-related quality of life (HRQoL) using EuroQol (EQ)-5D-5L index values and EQ visual analogue scale (VAS), and cognitive function using Mini Montreal Cognitive Assessment (Mini MoCA) test at 1 year. Deceased patients were assigned numerical zero for HRQoL as a state equal to death and zero for cognitive function outcomes as worst possible score, and we used multiple imputation for missing data on HRQoL and cognitive function. RESULTS: Among 1554 randomized patients, we obtained 1-year data on mortality in 97.9% of patients, HRQoL in 91.3%, and cognitive function in 86.3%. One-year mortality was 385/746 (51.3%) in the restrictive-fluid group versus 383/767 (49.9%) in the standard-fluid group, absolute risk difference 1.5%-points [99% confidence interval (CI) - 4.8 to 7.8]. Mean differences were 0.00 (99% CI - 0.06 to 0.05) for EQ-5D-5L index values, - 0.65 for EQ VAS (- 5.40 to 4.08), and - 0.14 for Mini MoCA (- 1.59 to 1.14) for the restrictive-fluid group versus the standard-fluid group. The results for survivors only were similar in both groups. CONCLUSIONS: Among adult ICU patients with septic shock, restrictive versus standard IV fluid therapy resulted in similar survival, HRQoL, and cognitive function at 1 year, but clinically important differences could not be ruled out.


Assuntos
Choque Séptico , Humanos , Adulto , Choque Séptico/terapia , Qualidade de Vida , Unidades de Terapia Intensiva , Cuidados Críticos , Sobreviventes
12.
Acta Anaesthesiol Scand ; 67(5): 588-598, 2023 05.
Artigo em Inglês | MEDLINE | ID: mdl-36847067

RESUMO

BACKGROUND: Gastrointestinal motility is important for adequate uptake of fluids and nutrition but is often impaired in hospitalised patients. Prokinetic agents enhance gastrointestinal motility and are prescribed for many hospitalised patients. In this scoping review, we aimed to systematically describe the body of evidence on the use of prokinetic agents in hospitalised patients. We hypothesised, that the body of evidence would be limited and derive from heterogeneous populations. METHODS: We conducted this scoping review in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews statement. We searched Medline, Embase, Epistemonikos and the Cochrane Library for studies assessing the use of prokinetic agents on any indication and outcome in adult hospitalised patients. We used a modified version of the Grading of Recommendations Assessment, Development and Evaluation (GRADE) to assess the certainty of evidence. RESULTS: We included 102 studies with a total of 8830 patients. Eighty-six studies were clinical trials (84%), and 52 (60%) of these were conducted in the intensive care unit, with feeding intolerance as the main indication. In the non-intensive care setting the indications were wider; most studies assessed use of prokinetic agents before gastroscopy to improve visualisation. The most studied prokinetic agent was metoclopramide (49% of studies) followed by erythromycin (31%). In total 147 outcomes were assessed with only 67% of the included studies assessing patient-centred outcomes, and with gastric emptying as the most frequently reported outcome. Overall, the data provided no firm evidence on the balance between the desirable and undesirable effects of prokinetic agents. CONCLUSIONS: In this scoping review, we found that the studies addressing prokinetic agents in hospitalised adults had considerable variations in indications, drugs and outcomes assessed, and that the certainty of evidence was judged to be low to very low.


Assuntos
Eritromicina , Metoclopramida , Adulto , Humanos , Eritromicina/uso terapêutico , Eritromicina/farmacologia , Esvaziamento Gástrico , Unidades de Terapia Intensiva , Metoclopramida/uso terapêutico , Metoclopramida/farmacologia
13.
Acta Anaesthesiol Scand ; 67(4): 481-486, 2023 04.
Artigo em Inglês | MEDLINE | ID: mdl-36636785

RESUMO

Critically ill patients are at risk of gastrointestinal (GI) bleeding. Counter measures to minimise this risk include the use of pharmacological stress ulcer prophylaxis (SUP). The effect of enteral nutrition as SUP on GI bleeding event rates is unknown. There are conflicting data describing the effect of co-administration of enteral nutrition with pharmacological SUP, and there is substantial variation in practice. We aim to conduct an exploratory post hoc analysis to evaluate the association of enteral nutrition with clinically important GI bleed rates in ICU patients included in the SUP-ICU trial, and to explore any interactions between enteral nutrition and pharmacologic SUP on patient outcomes. The SUP-ICU trial dataset will be used to assess if enteral nutrition is associated with the outcomes of interest. Extended Cox models will be used considering relevant competing events, including treatment allocation (SUP or placebo) and enteral nutrition as a daily time-varying covariate, with additional adjustment for severity of illness (SAPS II). Results will be presented as adjusted hazard ratios for treatment allocation and enteral nutrition, and for treatment allocation and enteral nutrition considering potential interactions with the other variable, all with 95% confidence intervals and p-values for the tests of interaction. All results will be considered as exploratory only. This post hoc analysis may yield important insights to guide practice and inform the design of future randomised clinical trial investigating the effect of enteral nutrition on GI bleeding.


Assuntos
Úlcera Péptica , Úlcera Gástrica , Humanos , Estado Terminal/terapia , Nutrição Enteral/métodos , Hemorragia Gastrointestinal/prevenção & controle , Unidades de Terapia Intensiva , Úlcera Péptica/prevenção & controle , Úlcera
15.
Acta Anaesthesiol Scand ; 67(1): 120-122, 2023 01.
Artigo em Inglês | MEDLINE | ID: mdl-36181393

RESUMO

BACKGROUND: An increasing number of patients undergo surgical procedures worldwide each year, and despite advances in quality and care, morbidity and mortality rates remain high. Perioperative hypotension is a well-described condition, and is associated with adverse outcomes. Both fluids and vasoactive agents are commonly used to treat hypotension, however, whether one vasoactive agent is preferable over another has yet to be explored. METHODS: In accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR) statement, we plan to conduct a scoping review of studies assessing the use of vasoactive agents in patients undergoing non-cardiac surgery. We will provide an overview of indications, agents used and outcomes assessed. We will assess and report the certainty of evidence according to the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. RESULTS: We will provide descriptive analyses of the included studies accompanied by tabulated results. CONCLUSION: The outlined scoping review will provide a summary of the body of evidence on the use of vasoactive agents in the non-cardiac surgical population.


Assuntos
Hipotensão , Humanos , Hipotensão/tratamento farmacológico , Revisões Sistemáticas como Assunto , Literatura de Revisão como Assunto
16.
Acta Anaesthesiol Scand ; 66(8): 1024-1026, 2022 09.
Artigo em Inglês | MEDLINE | ID: mdl-35675417

RESUMO

BACKGROUND: Gastrointestinal motility is an important contributor to the effective uptake of water and nutrition. However, it is often impaired in acutely ill hospitalised patients. Amongst other indications, prokinetic agents are used to improve GI motility, but the body of evidence is not well described. Accordingly, we aim to systematically describe and explore the body of evidence on the use of prokinetic agents in hospitalised adults. METHODS: In accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews statement, we plan to conduct a scoping review of studies assessing the use of prokinetic agents, for any indication, in hospitalised adults. We plan to assess study design, population, agents, indications and outcomes across included studies. When applicable, we plan to assess the certainty of evidence using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. RESULTS: We plan to provide descriptive analyses of the included studies accompanied by tabulated results and characterise knowledge gaps. CONCLUSION: The outlined scoping review will provide a summary of the body of evidence on the use, indications, effects and side effects of prokinetic agents in hospitalised adults.


Assuntos
Projetos de Pesquisa , Adulto , Humanos , Revisões Sistemáticas como Assunto
17.
Intensive Care Med ; 48(4): 426-434, 2022 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-35122105

RESUMO

PURPOSE: Patients in intensive care units (ICUs) are at risk of stress-related gastrointestinal (GI) bleeding and stress ulcer prophylaxis (SUP), including proton pump inhibitors, is widely used in the attempt to prevent this. In this secondary analysis of Stress Ulcer Prophylaxis in Intensive Care Unit (SUP-ICU) trial, we assessed 1-year outcomes in the pantoprazole vs. placebo groups. METHODS: In the SUP-ICU trial, 3298 acutely admitted ICU patients at risk of GI bleeding were randomly allocated, stratified for site, to pantoprazole or placebo. In this secondary analysis, we assessed clinically important GI bleedings in ICU and 1-year mortality, health care resource use (e.g. readmission with GI bleeding, use of home care and general practitioner), health care costs, and employment status for the Danish participants using registry data. RESULTS: Among the 2099 Danish participants, 2092 had data in the registries; 1045 allocated to pantoprazole and 1047 to placebo. The number of clinically important GI bleedings in ICU was 1.9 percentage points [95% CI 0.3-3.5] lower in the pantoprazole group vs. the placebo group, but none of the 1-year outcomes differed statistically significantly between groups, including total health care costs (€1954 [- 2992 to 6899]), readmission with GI bleeding (- 0.005 admissions [- 0.016 to 0.005]), 1-year mortality (- 0.013 percentage points [- 0.051 to 0.026]), and employment (- 0.178 weeks [- 0.390 to 0.034]). CONCLUSION: Among ICU patients at risk of GI bleeding, pantoprazole reduced clinically important GI bleeding in ICU, but this did not translate into a reduction in 1-year mortality, health care resource use or improvements in employment status.


Assuntos
Úlcera Péptica , Emprego , Hemorragia Gastrointestinal/tratamento farmacológico , Hemorragia Gastrointestinal/prevenção & controle , Humanos , Unidades de Terapia Intensiva , Pantoprazol/uso terapêutico , Úlcera Péptica/tratamento farmacológico , Úlcera Péptica/prevenção & controle , Inibidores da Bomba de Prótons/uso terapêutico
18.
Acta Anaesthesiol Scand ; 66(1): 156-162, 2022 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-34606090

RESUMO

BACKGROUND: Intensive care unit (ICU) patients receive numerous interventions, but knowledge about potential interactions between these interventions is limited. Co-enrolment in randomized clinical trials represents a unique opportunity to investigate any such interactions. We aim to assess interactions in four randomized clinical trials with overlap in inclusion periods and patient populations. METHODS: This protocol and statistical analysis plan describes a secondary explorative analysis of interactions in four international ICU trials on pantoprazole, oxygenations targets, haloperidol and intravenous fluids, respectively. The primary outcome will be 90-day all-cause mortality. The secondary outcome will be days alive and out of hospital in 90 days after randomization. All patients included in the intention-to-treat populations of the four trials will be included. Four co-primary analyses will be conducted, one with each of the included trials as reference using a logistic regression model adjusted for the reference trial's stratification variables and for the co-interventions with interactions terms. The primary analytical measure of interest will be the analyses' tests of interaction. A p-value below .05 will be considered statically significant. The stratification variable- and co-intervention-adjusted effect estimates will be reported with 95% confidence intervals without adjustments for multiplicity. CONCLUSION: This exploratory analysis will investigate the presence of any interactions between pantoprazole, oxygenation targets, haloperidol and amount of intravenous fluids in four international ICU trials using co-enrolment. Assessment of possible interactions represents valuable information to guide the design, statistical powering and conduct of future trials.


Assuntos
Cuidados Críticos , Haloperidol , Humanos , Unidades de Terapia Intensiva , Pantoprazol , Resultado do Tratamento
19.
Acta Anaesthesiol Scand ; 65(6): 792-800, 2021 07.
Artigo em Inglês | MEDLINE | ID: mdl-33635540

RESUMO

BACKGROUND: In previous studies of predictors of gastrointestinal (GI) bleeding in the intensive care unit (ICU), most patients received pharmacological stress ulcer prophylaxis (SUP). We aimed to assess associations between potential predictors of clinically important GI bleeding (CIB) and overt GI bleeding in adult ICU patients, while considering the effect and potential interaction with use of SUP. METHODS: We included 3291 acutely admitted adult ICU patients with risk factors for GI bleeding randomized to SUP (pantoprazole) or placebo in the SUP-ICU trial. We used logistic regression models adjusted for allocation to SUP to estimate associations between 23 potential predictors and CIB (primary outcome) and overt GI bleeding (secondary outcome). Furthermore, we assessed associations between potential predictors and both outcomes in each allocation group and assessed potential interaction with allocation to SUP. RESULTS: Increasing SAPS II and SOFA scores, use of circulatory support and renal replacement therapy were associated with increased risk of CIB and overt GI bleeding; chronic lung disease was associated with increased risk of overt GI bleeding. Results for the remaining potential predictors were compatible with both no difference or increased and decreased risks. We found no strong evidence for any interaction between treatment allocation and any potential predictors. CONCLUSION: In adult ICU patients at risk of GI bleeding, severity of illness, use of circulatory support and renal replacement therapy were associated with higher odds of CIB, with no strong evidence of interaction with SUP.


Assuntos
Úlcera Péptica , Adulto , Hemorragia Gastrointestinal/epidemiologia , Hemorragia Gastrointestinal/etiologia , Humanos , Unidades de Terapia Intensiva , Pantoprazol , Escore Fisiológico Agudo Simplificado
20.
Acta Anaesthesiol Scand ; 64(6): 714-728, 2020 07.
Artigo em Inglês | MEDLINE | ID: mdl-32060905

RESUMO

BACKGROUND: Acutely ill patients are at risk of stress-related gastrointestinal (GI) bleeding and prophylactic acid suppressants are frequently used. In this systematic review, we assessed the effects of stress ulcer prophylaxis (SUP) with proton pump inhibitors (PPIs) or histamine-2 receptor antagonists (H2RAs) versus placebo or no prophylaxis in acutely ill hospitalised patients. METHODS: We conducted the review according to the PRISMA statement, the Cochrane Handbook and GRADE, using conventional meta-analysis and trial sequential analysis (TSA). The primary outcomes were all-cause mortality, clinically important GI bleeding and serious adverse events (SAEs). The primary analyses included overall low risk of bias trials. RESULTS: We included 65 comparisons from 62 trials (n = 9713); 43 comparisons were from intensive care units. Only three trials (n = 3596) had overall low risk of bias. We did not find an effect on all-cause mortality (RR 1.03, 95% CI 0.94 to 1.14; TSA-adjusted CI 0.90 to 1.18; high certainty). The rate of clinically important GI bleeding was lower with SUP (RR 0.62, 95% CI 0.43 to 0.89; TSA-adjusted CI 0.14 to 2.81; moderate certainty). We did not find a difference in pneumonia rates (moderate certainty). Effects on SAEs, Clostridium difficile enteritis, myocardial ischaemia and health-related quality of life (HRQoL) were inconclusive due to sparse data. Analyses of all trials regardless of risk of bias were consistent with the primary analyses. CONCLUSIONS: We did not observe a difference in all-cause mortality or pneumonia with SUP. The incidence of clinically important GI bleeding was reduced with SUP, whereas any effects on SAEs, myocardial ischaemia, Clostridium difficile enteritis and HRQoL were inconclusive. STUDY REGISTRATION: PROSPERO registration number CRD42017055676; published study protocol: Marker, et al 2017 in Systematic Reviews.


Assuntos
Antiulcerosos/uso terapêutico , Cuidados Críticos/métodos , Hemorragia Gastrointestinal/prevenção & controle , Antagonistas dos Receptores H2 da Histamina/uso terapêutico , Pacientes Internados , Inibidores da Bomba de Prótons/uso terapêutico , Adulto , Estado Terminal , Hospitalização , Humanos
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