To assess the benefits and harms of SUP with PPI in adult, critically ill patients in the ICU.
ID
Source
Brief title
Condition
- Gastrointestinal vascular conditions
- Respiratory tract infections
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome: Mortality 90 days after randomization.
Secondary outcome
Secondary outcomes: proportion of patients with clinically important GI
bleeding, pneumonia, Clostridium difficile infection and myocardial ischemia,
proportion of patients with clinically important GI bleeding, proportion of
patients with pneumonia or clostridium difficile infections, 1 year mortality
post-randomization, days alive without organ support in the 90-day period,
serious adverse reactions and a health economic analysis.
Background summary
Critically ill patients in the intensive care unit (ICU) are at risk of stress
related gastrointestinal (GI) bleeding, and stress ulcer prophylaxis (SUP) is
recommended. However, the evidence on SUP is of low quantity and quality, and
studies have shown that proton pump inhibitors (PPI) may increase the risk of a
number of serious adverse events.
Study objective
To assess the benefits and harms of SUP with PPI in adult, critically ill
patients in the ICU.
Study design
An investigator-initiated, pragmatic, international, multicentre, randomized,
blinded, parallel-group trial of SUP with PPI versus placebo.
Intervention
Experimental intervention is intravenous pantoprazole 40 mg daily. Control
intervention is matching placebo (saline).
Study burden and risks
Since PPI is a well-established drug and thousands of patients are treated with
it every day, there will be no additional risk to patients receiving PPI. The
risk will be limited to the known adverse effects, including intolerance,
abdominal pain and headache (appendix 2)
From the available evidence we do not know whether there will be a higher risk
of GI bleeding, pneumonia, CDI, cardiovascular events or mortality in the PPI
or placebo groups [31].
Hanzeplein 1
Groningen 9700 RB
NL
Hanzeplein 1
Groningen 9700 RB
NL
Listed location countries
Age
Inclusion criteria
Adult patients admitted to the ICU with one or more of the following acute conditions: shock, renal replacement therapy, mechanical ventilation expected to last > 24 hours, any kind of coagulopathy, treatment with anticoagulant drugs or liver disease.
Exclusion criteria
contraindications to PPI, daily treatment with PPI and/or histamine-2-receptor antagonist, GI bleeding of any origin or known peptic ulcer during current hospital admission, organ transplant, withdrawal from active therapy or brain death, positive urine human chorionic gonadotropin (hCG) or plasma hCG or consent according to national regulations not obtainable
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2015-000318-24-NL |
| ClinicalTrials.gov | NCT02467621 |
| CCMO | NL54425.042.15 |