Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 2 of 2 for:    sup-icu

Sup-Icu RENal (SIREN) (SIREN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02718261
Recruitment Status : Completed
First Posted : March 24, 2016
Last Update Posted : September 11, 2018
Sponsor:
Collaborator:
Rigshospitalet, Copenhagen, Denmark (Prof. Moller, Dr. Krag)
Information provided by (Responsible Party):
Jörg Schefold, University Hospital Inselspital, Berne

Tracking Information
First Submitted Date  ICMJE March 14, 2016
First Posted Date  ICMJE March 24, 2016
Last Update Posted Date September 11, 2018
Actual Study Start Date  ICMJE February 2016
Actual Primary Completion Date September 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 22, 2017)
The proportion of patients with clinically important GI bleeding [ Time Frame: 90 days or length of ICU stay, as applicable ]
Original Primary Outcome Measures  ICMJE
 (submitted: March 22, 2016)
Total number of patients with clinically important gastrointestinal (GI)-bleeding episodes undergoing RRT therapy within the first 3 days following ICU admission ("RRT group") vs. in patients without need for RRT during ICU stay ("control group"). [ Time Frame: 90 days or length of ICU stay, as applicable ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 22, 2017)
  • Proportion of patients with one or more of the following adverse events: clinically important GI bleeding, pneumonia, C. difficile infection, or acute myocardial ischemia in the ICU [ Time Frame: 90 days or length of ICU stay, as applicable ]
  • Proportion of patients with serious adverse reactions [ Time Frame: 90 days or length of ICU stay, as applicable ]
  • Proportion of patients with one or more infectious adverse events (pneumonia or CDI) in the ICU [ Time Frame: 90 days or length of ICU stay, as applicable ]
  • Days alive without use of mechanical ventilation, renal replacement therapy, or circulatory support in the 90-day period [ Time Frame: 90 days or length of ICU stay, as applicable ]
  • 90-day and 1-year (365 days) mortality post-randomization [ Time Frame: 90 days/365 days or length of ICU stay, as applicable ]
  • Proportion of patients receiving treatment (interventions) to stop GI-bleeding (i.e. endoscopy/ open or laparoscopic surgery/ coiling). [ Time Frame: 90 days or length of ICU stay, as applicable ]
  • Number of units of packed red blood cells (RBCs) transfused. [ Time Frame: 90 days or length of ICU stay, as applicable ]
  • 90-day/360-day/ ICU mortality rate in "RRT group" vs. "ESRD group" vs. "RRT at any time on the ICU" vs. "control group" incl. analysis of verum/ placebo subgroups. [ Time Frame: 90 day, 360 days, or length of ICU stay, as applicable ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 22, 2016)
  • Total number of ICU patients with clinically important GI-bleeding episodes in "ESRD" vs. "RRT group" vs. RRT at any time during ICU stay vs. "control group" incl. analysis of verum/ placebo subgroups. [ Time Frame: 90 days or length of ICU stay, as applicable ]
  • Number of patients receiving interventions to stop GI-bleeding in "RRT group", "ESRD group", "RRT at any time on the ICU group", and "control group": incl. analysis of verum/ placebo subgroups. [ Time Frame: 90 days or length of ICU stay, as applicable ]
  • Number of GI bleeding events in "RRT group", "ESRD group", "RRT at any time on the ICU group", and "control group": incl. analysis of verum/ placebo subgroups. [ Time Frame: 90 days or length of ICU stay, as applicable ]
  • Number of units of red blood cells (RBC) transfused on ICU in "RRT group", "ESRD group", "RRT at any time on the ICU" and "control group" incl. assessment of verum/ placebo subgroups. [ Time Frame: 90 days or length of ICU stay, as applicable ]
  • Number of units of RBC transfused per day on ICU in "RRT group", "ESRD group", "RRT at any time on the ICU" and "control group" incl. assessment of verum/ placebo subgroups. [ Time Frame: 90 days or length of ICU stay, as applicable ]
  • Number of onset of pneumonia during ICU stay in "RRT group" vs. "ESRD group" vs. "RRT at any time on the ICU" vs. "control group" incl. analysis of verum/ placebo subgroups [ Time Frame: 90 days or length of ICU stay, as applicable ]
  • Days on treatment of Clostridium difficile enteritis in "RRT group" vs. "ESRD group" vs. "RRT at any time on the ICU" vs. "control group" incl. analysis of verum/ placebo subgroups [ Time Frame: 90 days or length of ICU stay, as applicable ]
  • ICU length of stay in "RRT group" vs. "ESRD group" vs. "RRT at any time on the ICU" vs. "control group" incl. analysis of verum/placebo subgroups [ Time Frame: 90 days or length of ICU stay, as applicable ]
  • 90-day/360-day/ ICU mortality rate in "RRT group" vs. "ESRD group" vs. "RRT at any time on the ICU" vs. "control group" incl. analysis of verum/ placebo subgroups. [ Time Frame: 90 day, 360 days, or length of ICU stay, as applicable ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures
 (submitted: March 22, 2016)
Risk for clinically important GI-bleeding episodes in "RRT group", "ESRD group", "RRT at any time on the ICU", and "control group" before the background of baseline disease severity/ demographics etc. [ Time Frame: 90 days or length of ICU stay, as applicable ]
 
Descriptive Information
Brief Title  ICMJE Sup-Icu RENal (SIREN)
Official Title  ICMJE Sup-Icu RENal (SIREN) - a Sub-analysis of the Prospective SUP (Stress Ulcer Prophylaxis)-ICU Trial on the Risk of GI- Bleeding in ICU Patients Receiving Renal Replacement Therapy
Brief Summary

Data show that episodes of bleeding may often be observed in critically ill patients with dialysis-dependent acute renal failure (ARF) on renal replacement therapy (RRT). From a clinical perspective, patients with dialysis-dependent ARF and end-stage renal disease (ESRD) may be considered a high risk population in regard to e.g. development of gastrointestinal (GI-) bleeding.

In the current prospective subanalysis "SIREN" of the randomized placebo-controlled clinical trial "SUP-ICU" (NCT02467621), the investigators seek to elucidate whether the subpopulation of critically ill patients with acute kidney injury requiring renal replacement therapy (RRT) benefit from prophylactic treatment with a proton-pump-inhibitor such as pantoprazole.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Other
Condition  ICMJE
  • Critical Illness
  • Acute Kidney Injury
  • End-stage Renal Disease
  • Renal Replacement Therapy
  • Proton Pump Inhibitor
Intervention  ICMJE
  • Drug: Pantoprazole
  • Drug: Saline 0.9% (matching placebo)
Study Arms  ICMJE
  • Experimental: Verum (pantoprazole)
    Intervention: Drug: Pantoprazole
  • Placebo Comparator: Placebo
    0.9% saline
    Intervention: Drug: Saline 0.9% (matching placebo)
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: March 22, 2016)
3350
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2018
Actual Primary Completion Date September 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • please refer to SUP-ICU (NCT02467621) trial

Exclusion Criteria:

  • please refer to SUP-ICU (NCT02467621) trial
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,   Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02718261
Other Study ID Numbers  ICMJE SIREN
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jörg Schefold, University Hospital Inselspital, Berne
Study Sponsor  ICMJE University Hospital Inselspital, Berne
Collaborators  ICMJE Rigshospitalet, Copenhagen, Denmark (Prof. Moller, Dr. Krag)
Investigators  ICMJE Not Provided
PRS Account University Hospital Inselspital, Berne
Verification Date September 2018

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