Stress Ulcer Prophylaxis in the Intensive Care Unit (SUP-ICU)

Dr. Morten Hylander Møller

Status and phase

Completed

Phase 4

Conditions

Stress Ulcers

Gastrointestinal Bleeding

Treatments

Drug: Pantoprazole

Other: Saline (0.9%)

Study type

Interventional

Funder types

Other

Identifiers

NCT02467621

RH-ITA-006

Details and patient eligibility

About

Stress ulcer prophylaxis (SUP) is standard of care in the intensive care unit (ICU), however the quantity and quality of evidence is low and potential harm has been reported.

The aim of the SUP-ICU trial is to asses the overall benefits and harms of SUP with proton pump inhibitor in adult critically ill patients in the ICU.

Full description

Critically ill patients in the ICU are at risk of stress related gastrointestinal (GI) bleeding, and SUP is recommended. However, the quantity and quality of evidence supporting SUP is low and has been questioned. Furthermore studies have shown that proton pump inhibitors (PPIs) may increase the risk of pneumonia, clostridium difficile infection and acute myocardial ischemia. The aim of the SUP-ICU trial is to assess the benefits and harms of SUP with PPI in adult critically ill patients in the ICU.

Enrollment

3,350 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Acute admission to the ICU
Age ≥ 18 years
One or more of the following risk factors:
- Shock (continuous infusion with vasopressors or inotropes, systolic blood pressure < 90 mmHg, mean arterial blood pressure < 70 mmHg or lactate > 4 mmol/l)
- Acute or chronic intermittent or continuous renal replacement therapy
- Invasive mechanical ventilation which is expected to last > 24 hours
- Coagulopathy (platelets < 50 x 109/l or international normalized ratio (INR) > 1.5 or prothrombin time (PT) > 20 seconds) documented within the last 24 hours
- Ongoing treatment with anticoagulant drugs (prophylaxis doses excluded)
- History of coagulopathy (platelets < 50 x 109/l or INR > 1.5 or PT > 20 seconds) within 6 months prior to hospital admission
- History of chronic liver disease (portal hypertension, cirrhosis proven by biopsy, computed tomography (CT) scan or ultrasound, history of variceal bleeding or hepatic encephalopathy in the past medical history)

Exclusion criteria

Contraindications to PPI
Ongoing treatment with PPI and/or H2RA on a daily basis
GI bleeding of any origin during current hospital admission
Diagnosed with peptic ulcer during current hospital admission
Organ transplant during current hospital admission
Withdrawal from active therapy or brain death
Fertile woman with positive urine human chorionic gonadotropin (hCG) or plasma-hCG
Consent according to national regulations not obtainable