Stress Ulcer Prophylaxis in the Intensive Care Unit

Gastrointestinal Bleeding Clinical Trial

— SUP-ICU  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02467621
• Other study ID #: RH-ITA-006
• Status: Completed
• Phase: Phase 4
• Start date: January 2016
• Est. completion date: January 21, 2018

Study information

• Verified date: October 2022
• Source: Scandinavian Critical Care Trials Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3350
• Est. completion date: January 21, 2018
• Est. primary completion date: October 22, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gastrointestinal Bleeding
• Gastrointestinal Hemorrhage
• Stress Ulcers
• Ulcer

Intervention

Drug:
• Pantoprazole
40 mg x 1 daily intravenously from ICU admission to ICU discharge

Other:
• Saline (0.9%)
10 ml of isotonic saline x 1 daily intravenously from ICU admission to ICU discharge

Locations

Country	Name	City	State
Denmark	Dept. of Intensive Care, Aalborg University Hospital	Aalborg
Denmark	Dept. of Intensive Care, Århus University Hospital Nørrebrogade	Aarhus
Denmark	Dept. of Intensive Care, Århus University Hospital Skejby	Arhus
Denmark	Dept. of Intensive Care 4131, Copenhagen University Hospital Rigshospitalet	Copenhagen
Denmark	Dept. of Intensive Care, Bispebjerg Hospital	Copenhagen
Denmark	Dept. of Neurointensive Care, Copenhagen University Hospital Rigshospitalet	Copenhagen
Denmark	Dept. of Intensive Care, Copenhagen University Hospital Herlev	Herlev
Denmark	Dept. of Intensive Care, Herning Hospital	Herning
Denmark	Dept. of Intensive Care, Hillerød Hospital	Hillerød
Denmark	Dept. of Intensive Care, Hjørring Hospital	Hjørring
Denmark	Dept. of Intensive Care, Holbæk Hospital	Holbæk
Denmark	Dept. of Intensive Care, Holstebro Hospital	Holstebro
Denmark	Dept. of Intensive Care, Køge University Hospital	Køge
Denmark	Dept. of Intensive Care, Nykøbing Falster Sygehus	Nykøbing Falster
Denmark	Dept. of Intensive Care, Randers Hospital	Randers
Denmark	Dept. of Intensive Care, Roskilde Hospital	Roskilde
Denmark	Dept. of Intensive Care, Slagelse Hospital	Slagelse
Denmark	Dept. of Intensive Care, Vejle Hospital	Vejle
Denmark	Dept. of Intensive Care, Viborg Hospital	Viborg
Finland	Dept. of Intensive Care, Helsinki University Hospital	Helsinki
Finland	Dept. of Intensive Care, Kuopio University Hospital	Kuopio
Finland	Dept. of Intensive Care, Oulu University Hospital	Oulu
Finland	Dept. of Intensive Care, Tampere University Hospital	Tampere
Finland	Dept. of Intensive Care, Turku University Hospital	Turku
Netherlands	Dept. of Intensive Care, University Medical Center Groningen	Groningen
Netherlands	Dept. of Intensive Care, Heerlen Hospital	Heerlen
Norway	Dept. of Intensive Care, Bergen University Hospital	Bergen
Norway	Dept. of Intensive Care, Akershus University Hospital	Lørenskog
Norway	Dept. of Intensive Care, Oslo University Hospital	Oslo
Norway	Dept. of Intensive Care, Stavanger University Hospital	Stavanger
Switzerland	Dept. of Intensive Care, Basel University Hospital	Basel
Switzerland	Dept. of Intensive Care, Bern University Hospital	Bern
United Kingdom	Dept. of Intensive Care, University Hospital of Wales	Cardiff

Sponsors (3)

Lead Sponsor	Collaborator
Dr. Morten Hylander Møller	Copenhagen Trial Unit, Center for Clinical Intervention Research, Rigshospitalet, Denmark

Countries where clinical trial is conducted

Denmark,  Finland,  Netherlands,  Norway,  Switzerland,  United Kingdom, 

References & Publications (2)

Krag M, Perner A, Wetterslev J, Wise MP, Borthwick M, Bendel S, McArthur C, Cook D, Nielsen N, Pelosi P, Keus F, Guttormsen AB, Moller AD, Møller MH; SUP-ICU co-authors. Prevalence and outcome of gastrointestinal bleeding and use of acid suppressants in acutely ill adult intensive care patients. Intensive Care Med. 2015 May;41(5):833-45. doi: 10.1007/s00134-015-3725-1. Epub 2015 Apr 10. — View Citation

Krag M, Perner A, Wetterslev J, Wise MP, Hylander Møller M. Stress ulcer prophylaxis versus placebo or no prophylaxis in critically ill patients. A systematic review of randomised clinical trials with meta-analysis and trial sequential analysis. Intensive Care Med. 2014 Jan;40(1):11-22. doi: 10.1007/s00134-013-3125-3. Epub 2013 Oct 19. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	Landmark mortality 90-days after randomization	90 days
Secondary	Number of Participants With Clinically Important GI Bleeding, Pneumonia, Clostridium Difficile Infection or Acute Myocardial Ischemia	Composite outcome of the number of participants with one or more of the mentioned conditions in the ICU	Until ICU discharge, maximum 90 days
Secondary	Number of Participants With Clinically Important GI Bleeding	Number of participants with one or more episodes of clinically important GI bleeding in the ICU	Until ICU discharge, maximum 90 days
Secondary	Number of Participants With One or More Infectious Adverse Events	Number of participants with one or more episodes of pneumonia or clostridium difficile infection in the ICU	Until ICU discharge, maximum 90 days
Secondary	Mortality	Data for landmark mortality 1 year after randomization.	1 year
Secondary	Percentage of Days Alive Without Organ Support	Percentage of days alive and free from mechanical ventilation, circulatory support and renal replacement therapy	Within 90 days
Secondary	Number of Serious Adverse Reactions	Serious adverse reactions are: anaphylactic reactions, agranulocytosis, pancytopenia, acute hepatic failure, Steven Johnsons Syndrome and toxic epidermal necrolysis, interstitial nephritis and angioedema.	Until ICU discharge, maximum 90 days
Secondary	A Health Economic Analysis	This has not been completed yet.	90 days