Study Overview

Details

NCTId: NCT02467621

Status: Completed

Condition: Stress Ulcers

Study Type: Interventional

Sponsor: Dr. Morten Hylander Møller

Study Description

Brief

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.

Detailed

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.

Eligibility

Criteria:

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 4 mmol/l)
Acute or chronic intermittent or continuous renal replacement therapy
Invasive mechanical ventilation which is expected to last > 24 hours
Coagulopathy (platelets 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 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

Healthy Volunteers: No

Gender: All

Min Age: 18 Years

Contacts

Dept. of Intensive Care, University Hospital of Wales

Cardiff

3010

United Kingdom

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