Timing of onset of gastrointestinal bleeding in the ICU: Protocol for a preplanned observational study

Granholm, Anders; Lange, Theis; Anthon, Carl Thomas; Marker, Søren; Krag, Mette; Meyhoff, Tine Sylvest; Wise, Matt P.; Borthwick, Mark; Bendel, Stepani; Keus, Frederik; Guttormsen, Anne Berit; Schefold, Joerg C.; Wetterslev, Jørn; Perner, Anders; Møller, Morten Hylander

doi:10.1111/aas.13144

Cited by 6 publications

(14 citation statements)

References 23 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…This pre‐planned, exploratory substudy of the SUP‐ICU randomized clinical trial (RCT) was conducted according to a protocol and statistical analysis plan finalized before the closure of the trial database on 21 March 2018 and subsequently published . The manuscript was prepared according to the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement .…”

Section: Methodsmentioning

confidence: 99%

“…Earlier and later CIB were defined according to the distribution of CIB onset times in the SUP‐ICU inception cohort study . Additional variable definitions can be found in the supplement or the SUP‐ICU publications …”

Section: Methodsmentioning

confidence: 99%

“…Due to the limited number of CIB events, we conducted a number of different Cox models. In the first model, the association between allocation to pantoprazole (vs placebo) and CIB onset was assessed, while additional models assessed the effect of each additional baseline variable and CIB in turn . Models were adjusted for treatment allocation and severity of illness using the Simplified Acute Physiology Score (SAPS) II; the two models assessing these variables were only adjusted for the other variable.…”

Section: Methodsmentioning

confidence: 99%

“…The sample size was fixed, as per the SUP‐ICU trial, and we expected approximately 100‐120 patients with CIB …”

Section: Methodsmentioning

confidence: 99%

“…Two‐tailed P ‐values <.05 and 95% confidence intervals (CIs) not including 1.00 were considered statistically significant. We performed no corrections for multiple testing as all analyses presented in this study should be considered exploratory and hypothesis‐generating . All analyses were conducted using R version 3.5.3 (R Core Team, R Foundation for Statistical Computing, Vienna, Austria).…”

Section: Methodsmentioning

confidence: 99%

See 4 more Smart Citations

Time to onset of gastrointestinal bleeding in the SUP‐ICU trial: A pre‐planned substudy

Granholm

Lange

Anthon

et al. 2019

Acta Anaesthesiol Scand

Self Cite

View full text Add to dashboard Cite

Background:The aetiology and risk factors for clinically important gastrointestinal bleeding (CIB) in adult ICU patients may differ according to the onset of CIB, which could affect the balance between benefits and harms of stress ulcer prophylaxis (SUP). Methods: We assessed the time to CIB in the Stress Ulcer Prophylaxis in the IntensiveCare Unit (SUP-ICU) trial. We assessed if associations between baseline characteristics including allocation to SUP and CIB changed during time in the ICU, specifically in the later (after day 2) compared to the earlier (first 2 days) period, using Cox models adjusted for SAPS II and allocation to SUP. Additionally, we described baseline characteristics and CIB episodes stratified by earlier/later/no CIB and 90-day mortality status. Results:Clinically important gastrointestinal bleeding occurred in 110/3291 (3.3%) patients after a median of 6 (interquartile range 2-13) days; 25.5% of the episodes occurred early. Higher SAPS II was consistently associated with increased risk of CIB (hazard ratio (HR) 1.03, 95% confidence interval (CI) 1.01-1.05 in the earlier period vs HR 1.02, 95% CI 1.01-1.03 in the later period; P = .37); university hospital admission was associated with decreased risk of earlier CIB (HR 0.30, 95% CI 0.14-0.63); | 1347 GRANHOLM et AL.

show abstract

Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

“…The sample size was fixed, as per the SUP‐ICU trial, and we expected approximately 100‐120 patients with CIB …”

Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

See 3 more Smart Citations

Time to onset of gastrointestinal bleeding in the SUP‐ICU trial: A pre‐planned substudy

Granholm

Lange

Anthon

et al. 2019

Acta Anaesthesiol Scand

Self Cite

View full text Add to dashboard Cite

show abstract

Prevention of gastrointestinal bleeding in critically ill patients

Al‐Dorzi

Arabi

2020

Current Opinion in Critical Care

View full text Add to dashboard Cite

Purpose of review This review focuses on the current literature on the epidemiology and prevention of stress-induced clinically important gastrointestinal bleeding in ICU patients. Recent findings The incidence of stress-induced clinically important gastrointestinal bleeding in critically ill patients seems to be decreasing. Observational studies and an exploratory randomized controlled trial suggest that early enteral nutrition may be effective in preventing gastrointestinal bleeding in patients who are not at high risk. Recent systemic reviews and meta-analyses indicate that proton pump inhibitors and H2 receptor antagonists are more effective than placebo in preventing clinically important gastrointestinal bleeding, especially in high-risk and very high-risk patients, but do not reduce mortality. Although observational data suggested an association of proton pump inhibitors and H2 receptor antagonists with Clostridium difficile infection and pneumonia, this association was not confirmed in randomized controlled trials. Summary The incidence of stress-induced clinically important gastrointestinal bleeding in critically ill patients seems to have decreased over time. Even though stress ulcer prophylaxis in critically ill patients has been a research focus for decades, many questions remain unanswered, such as which groups of patients are likely to benefit and what pharmacologic agent is associated with the best benefit-to-harm ratio.

show abstract

Is Gastrointestinal Bleeding a Problem for COVID-19 Intensive Care Unit Patients?

Negro

Villa

Cardinali

et al. 2023

Gastroenterology Nursing

View full text Add to dashboard Cite

Gastrointestinal bleeding (GIB) caused by stress ulceration is a recognized condition that can affect intensive care unit (ICU) patients, and increases mortality and morbidity rates (Cook et al., 2001;Negro, Villa, Rolandi, Lucchini, & Bambi, 2022). Overt GIB is defined as visual evidence of gastrointestinal (GI) bleeding with hemodynamics and hemoglobin levels being affected or requiring transfusion (Granholm et al., 2019). Risk factors associated with overt GIB are coagulopathy, shock, sepsis, acute hepatic failure, chronic liver disease, acute kidney injury, male gender, and acute myocardial infarction (Granholm et al., 2019). Critically ill patients affected by coronavirus disease-2019 (COVID)-19 need prophylactic anticoagulation therapy to reduce the complications caused by immobilization and thromboembolic risks (Thachil et al., 2020). although this treatment will protect from a thromboembolic event, it can increase the risk of bleeding.

show abstract

Timing of onset of gastrointestinal bleeding in the ICU: Protocol for a preplanned observational study

Cited by 6 publications

References 23 publications

Time to onset of gastrointestinal bleeding in the SUP‐ICU trial: A pre‐planned substudy

Time to onset of gastrointestinal bleeding in the SUP‐ICU trial: A pre‐planned substudy

Prevention of gastrointestinal bleeding in critically ill patients

Is Gastrointestinal Bleeding a Problem for COVID-19 Intensive Care Unit Patients?

Contact Info

Product

Resources

About