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Trial record 1 of 2 for:    sup-icu
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Stress Ulcer Prophylaxis in the Intensive Care Unit (SUP-ICU)

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ClinicalTrials.gov Identifier: NCT02467621
Recruitment Status : Completed
First Posted : June 10, 2015
Results First Posted : June 7, 2019
Last Update Posted : October 3, 2019
Sponsor:
Collaborators:
Rigshospitalet, Denmark
Copenhagen Trial Unit, Center for Clinical Intervention Research
Information provided by (Responsible Party):
Dr. Morten Hylander Møller, Scandinavian Critical Care Trials Group

Tracking Information
First Submitted Date  ICMJE June 5, 2015
First Posted Date  ICMJE June 10, 2015
Results First Submitted Date  ICMJE October 29, 2018
Results First Posted Date  ICMJE June 7, 2019
Last Update Posted Date October 3, 2019
Actual Study Start Date  ICMJE January 2016
Actual Primary Completion Date October 22, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 9, 2015)
Mortality [ Time Frame: 90 days ]
Landmark mortality 90-days after randomization
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 11, 2019)
  • Number of Participants With Clinically Important GI Bleeding, Pneumonia, Clostridium Difficile Infection or Acute Myocardial Ischemia [ Time Frame: Until ICU discharge, maximum 90 days ]
    Composite outcome of the number of participants with one or more of the mentioned conditions in the ICU
  • Number of Participants With Clinically Important GI Bleeding [ Time Frame: Until ICU discharge, maximum 90 days ]
    Number of participants with one or more episodes of clinically important GI bleeding in the ICU
  • Number of Participants With One or More Infectious Adverse Events [ Time Frame: Until ICU discharge, maximum 90 days ]
    Number of participants with one or more episodes of pneumonia or clostridium difficile infection in the ICU
  • Mortality [ Time Frame: 1 year ]
    Data for landmark mortality 1 year after randomization.
  • Percentage of Days Alive Without Organ Support [ Time Frame: Within 90 days ]
    Percentage of days alive and free from mechanical ventilation, circulatory support and renal replacement therapy
  • Number of Serious Adverse Reactions [ Time Frame: Until ICU discharge, maximum 90 days ]
    Serious adverse reactions are: anaphylactic reactions, agranulocytosis, pancytopenia, acute hepatic failure, Steven Johnsons Syndrome and toxic epidermal necrolysis, interstitial nephritis and angioedema.
  • A Health Economic Analysis [ Time Frame: 90 days ]
    This has not been completed yet.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 9, 2015)
  • Proportion of patients with clinically important GI bleeding, pneumonia, clostridium difficile infection or acute myocardial ischemia [ Time Frame: Until ICU discharge, maximum 90 days ]
    Composite outcome of the proportion of patients with one or more of the mentioned conditions in the ICU
  • Proportion of patients with clinically important GI bleeding [ Time Frame: Until ICU discharge, maximum 90 days ]
    Proportion of patients with one or more episodes of clinically important GI bleeding in the ICU
  • Proportion of patients with one or more infectious adverse events [ Time Frame: Until ICU discharge, maximum 90 days ]
    Proportion of patients with one or more episodes of pneumonia or clostridium difficile infection in the ICU
  • Mortality [ Time Frame: 1 year ]
    Landmark mortality 1 year after randomization
  • Days alive without organ support [ Time Frame: Within 90 days ]
    Percentage of days alive and free from mechanical ventilation, circulatory support and renal replacement therapy
  • Number of Serious Adverse Reactions [ Time Frame: Until ICU discharge, maximum 90 days ]
    Serious adverse reactions are: anaphylactic reactions, agranulocytosis, pancytopenia, acute hepatic failure, Steven Johnsons Syndrome and toxic epidermal necrolysis, interstitial nephritis and angioedema.
  • A Health Economic Analysis [ Time Frame: 90 days ]
    The analytic details will be based on the results of the trial and specified (cost-benefit vs cost-minimisation analyses).
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Stress Ulcer Prophylaxis in the Intensive Care Unit
Official Title  ICMJE Stress Ulcer Prophylaxis in the Intensive Care Unit (SUP-ICU)
Brief 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.

Detailed 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Gastrointestinal Bleeding
  • Stress Ulcers
Intervention  ICMJE
  • Drug: Pantoprazole
    40 mg x 1 daily intravenously from ICU admission to ICU discharge
    Other Name: Pantoloc
  • Other: Saline (0.9%)
    10 ml of isotonic saline x 1 daily intravenously from ICU admission to ICU discharge
Study Arms  ICMJE
  • Experimental: Proton pump inhibitor (PPI)
    Pantoprazole 40 mg
    Intervention: Drug: Pantoprazole
  • Placebo Comparator: Normal saline
    Saline (0.9%)
    Intervention: Other: Saline (0.9%)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 9, 2015)
3350
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 21, 2018
Actual Primary Completion Date October 22, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark,   Finland,   Netherlands,   Norway,   Switzerland,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02467621
Other Study ID Numbers  ICMJE RH-ITA-006
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Responsible Party Dr. Morten Hylander Møller, Scandinavian Critical Care Trials Group
Study Sponsor  ICMJE Dr. Morten Hylander Møller
Collaborators  ICMJE
  • Rigshospitalet, Denmark
  • Copenhagen Trial Unit, Center for Clinical Intervention Research
Investigators  ICMJE
Principal Investigator: Morten Hylander Møller, MD, PhD Rigshospitalet, Denmark
Study Chair: Anders Perner, MD, PhD Rigshospitalet, Denmark
PRS Account Scandinavian Critical Care Trials Group
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP