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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02467621
Other study ID # RH-ITA-006
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
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
Health authority
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

Study Design


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
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