CompletedPhase 3

Re-Evaluating the Inhibition of Stress Erosions: Gastrointestinal Bleeding Prophylaxis In ICU

Australia, Canada91 participantsStarted 2015-05

Plain-language summary

The purpose of the this Pilot Trial is to determine the feasibility of conducting a large randomized controlled trial (RCT), that aims to examine the efficacy and safety of using pantoprazole compared to placebo for stress ulcer prophylaxis in critically ill mechanically ventilated patients in the ICU.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Adults ≥ 18 years
✓. Anticipated invasive mechanical ventilation of ≥48 hours, determined by the intensivist

Exclusion criteria

✕. Invasive mechanical ventilation \>72 hours before randomization.
✕. Patients who must receive PPI due to active bleeding or increased bleeding risk (e.g., patients with acute GI bleeding, recent severe esophagitis, Zollinger Ellison syndrome, Barrett's esophagus, peptic ulcer bleeding within 8 weeks \[mild dyspepsia or mild gastroesophageal reflex disease will not be excluded\])
✕. Receiving dual antiplatelet therapy aspirin and clopidogrel prior to randomization
✕. Palliative care or decision to withdraw advanced life support (patients with a decision to forgo cardiopulmonary resuscitation will not be excluded)
✕. Previous enrolment in this or a related trial
✕. Pregnancy
✕. Physician, patient, or substitute decision maker (SDM) declines
✕. Two or more 'daily doses' of prophylaxis with H2RA or PPI (one day of a single PPI dose is not an exclusion criterion if once daily dosing of PPI prophylaxis was administered; one day of bid \[twice daily\] dosing of an H2RA is not an exclusion criterion if twice daily H2RA prophylaxis was administered; one day of tid \[thrice daily\] dosing of an H2RA is not an exclusion criterion if thrice daily H2RA prophylaxis was administered).

What they're measuring

Consent Rate

Timeframe: 12 months

Recruitment Rate

Timeframe: 12 months

Protocol Adherence

Timeframe: 12 months

Trial details

NCT IDNCT02290327

SponsorMcMaster University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-01

View on ClinicalTrials.gov More Stress Ulcer Prophylaxis trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Adults ≥ 18 years
✓. Anticipated invasive mechanical ventilation of ≥48 hours, determined by the intensivist

Exclusion criteria

✕. Invasive mechanical ventilation \>72 hours before randomization.
✕. Patients who must receive PPI due to active bleeding or increased bleeding risk (e.g., patients with acute GI bleeding, recent severe esophagitis, Zollinger Ellison syndrome, Barrett's esophagus, peptic ulcer bleeding within 8 weeks \[mild dyspepsia or mild gastroesophageal reflex disease will not be excluded\])
✕. Receiving dual antiplatelet therapy aspirin and clopidogrel prior to randomization
✕. Palliative care or decision to withdraw advanced life support (patients with a decision to forgo cardiopulmonary resuscitation will not be excluded)
✕. Previous enrolment in this or a related trial
✕. Pregnancy
✕. Physician, patient, or substitute decision maker (SDM) declines
✕. Two or more 'daily doses' of prophylaxis with H2RA or PPI (one day of a single PPI dose is not an exclusion criterion if once daily dosing of PPI prophylaxis was administered; one day of bid \[twice daily\] dosing of an H2RA is not an exclusion criterion if twice daily H2RA prophylaxis was administered; one day of tid \[thrice daily\] dosing of an H2RA is not an exclusion criterion if thrice daily H2RA prophylaxis was administered).