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Trial record 2 of 2 for:    sup-icu

Sup-Icu RENal (SIREN) (SIREN)

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ClinicalTrials.gov Identifier: NCT02718261
Recruitment Status : Recruiting
First Posted : March 24, 2016
Last Update Posted : March 12, 2018
Sponsor:
Collaborator:
Rigshospitalet, Copenhagen, Denmark (Prof. Moller, Dr. Krag)
Information provided by (Responsible Party):
Jörg Schefold, University Hospital Inselspital, Berne

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.


Condition or disease Intervention/treatment Phase
Critical Illness Acute Kidney Injury End-stage Renal Disease Renal Replacement Therapy Proton Pump Inhibitor Drug: Pantoprazole Drug: Saline 0.9% (matching placebo) Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Other
Official Title: 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
Study Start Date : February 2016
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : August 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Verum (pantoprazole) Drug: Pantoprazole
Placebo Comparator: Placebo
0.9% saline
Drug: Saline 0.9% (matching placebo)



Primary Outcome Measures :
  1. The proportion of patients with clinically important GI bleeding [ Time Frame: 90 days or length of ICU stay, as applicable ]

Secondary Outcome Measures :
  1. 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 ]
  2. Proportion of patients with serious adverse reactions [ Time Frame: 90 days or length of ICU stay, as applicable ]
  3. 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 ]
  4. 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 ]
  5. 90-day and 1-year (365 days) mortality post-randomization [ Time Frame: 90 days/365 days or length of ICU stay, as applicable ]
  6. 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 ]
  7. Number of units of packed red blood cells (RBCs) transfused. [ Time Frame: 90 days or length of ICU stay, as applicable ]
  8. 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • please refer to SUP-ICU (NCT02467621) trial

Exclusion Criteria:

  • please refer to SUP-ICU (NCT02467621) trial

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02718261


Contacts
Contact: Joerg C Schefold, MD +41-31-6325397 joerg.schefold@insel.ch

Locations
Denmark
Rigshospitalet Recruiting
Copenhagen, Denmark
Contact: Mette Krag, MD       mette.krag.01@regionh.dk   
Switzerland
Dept. of Intensive Care Medicine, University of Bern, Not yet recruiting
Bern, Switzerland, 3010
Sponsors and Collaborators
University Hospital Inselspital, Berne
Rigshospitalet, Copenhagen, Denmark (Prof. Moller, Dr. Krag)

Additional Information:
Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: NCT02467621
SUP-ICU Website

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jörg Schefold, SIREN principle investigator, University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT02718261     History of Changes
Other Study ID Numbers: SIREN
First Posted: March 24, 2016    Key Record Dates
Last Update Posted: March 12, 2018
Last Verified: March 2018

Additional relevant MeSH terms:
Kidney Failure, Chronic
Acute Kidney Injury
Critical Illness
Renal Insufficiency, Chronic
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Disease Attributes
Pathologic Processes
Pantoprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action