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

NCT02290327 | Completed Phase 3

• 1 other identifier: REV-06MAR14
• Study Type: interventional
• Target: 91
• Locations: 3 countries
• Sites: 10

Brief 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.

Conditions

Stress Ulcer Prophylaxis

Keywords

Stress ulcer bleeding; proton pump inhibitors; pneumonia; clostridium difficile infection

Outcome Measures

Primary Outcomes (3)

• Consent Rate

  This will be calculated as the overall proportion of consented patients of those substitute decision makers (SDMs) approached (with 95% CI). A successful consent rate will be defined as ≥70% of SDMs approached to consent.

  12 months

• Recruitment Rate

  A successful recruitment rate will be defined as achieving enrolment of 90 patients, conventionally expressed as 2 patients per center per month over 12 months.

  12 months

• Protocol Adherence

  This will be calculated as doses of study drug administered as a proportion of doses prescribed and associated 95% confidence intervals. A successful adherence will be defined as ≥80% of prescribed drugs being administered.

  12 months

Secondary Outcomes (4)

• Clinically important upper gastrointestinal bleeding

  During ICU stay (expected average is 10 days)

• Ventilator associated pneumonia

  During ICU stay (expected average is 10 days)

• Mortality

  During ICU and hospital stay (expected average ICU stay is 10 days, expected average hospital stay is 30 days)

• Clostridium Difficile infection

  During ICU stay (expected average ICU stay is 10 days)

Study Arms (2)

Placebo

PLACEBO COMPARATOR

50 ml of 0.9% Normal Saline Intravenously once daily

Drug: Placebo

Pantoprazole

ACTIVE COMPARATOR

Pantoprazole 40 mg in 50 ml 0.9% Normal Saline Intravenously once daily

Drug: Pantoprazole

Interventions

Pantoprazole DRUG

Proton pump inhibitor

Pantoprazole

Placebo DRUG

50 ml of 0.9% normal saline

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• McMaster University: lead
• The Physicians' Services Incorporated Foundation: collaborator

Study Sites (10)

Royal Adelaide

Adelaide, Australia

Location

Queen Elizabeth II

Halifax, Nova Scotia, Canada

Location

St. Joseph's HealthCare Hospital

Hamilton, Ontario, L9K 1N3, Canada

Location

Jurvinski Hospital

Hamilton, Ontario, Canada

Location

Kingston General Hospital

Kingston, Ontario, Canada

Location

Ottawa Civic Hospital

Ottawa, Ontario, Canada

Location

Ottawa General Hospital

Ottawa, Ontario, Canada

Location

Mount Sinai Hospital

Toronto, Ontario, Canada

Location

St Michael's Hospital

Toronto, Ontario, Canada

Location

Dammam University

Dammam, Eastern Province, Saudi Arabia

Location

Related Publications (1)

• Alhazzani W, Guyatt G, Marshall JC, Hall R, Muscedere J, Lauzier F, Thabane L, Alshahrani M, English SW, Arabi YM, Deane AM, Karachi T, Rochwerg B, Finfer S, Daneman N, Zytaruk N, Heel-Ansdell D, Cook D, Of OB. Re-evaluating the Inhibition of Stress Erosions (REVISE): a protocol for pilot randomized controlled trial. Ann Saudi Med. 2016 Nov-Dec;36(6):427-433. doi: 10.5144/0256-4947.2016.427.

  PMID: 27920416 DERIVED

MeSH Terms

Conditions

Pneumonia; Clostridium Infections

Interventions

Pantoprazole

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Waleed Alhazzani, MD,FRCPC,MSc

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2014
• First Posted: November 14, 2014
• Study Start: May 1, 2015
• Primary Completion: January 1, 2016
• Last Updated: February 8, 2016

Record last verified: 2016-02

Locations

SA (1); CA (8); AU (1)