NCT02718261

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,350

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Feb 2016

Typical duration for phase_4

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 14, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 24, 2016

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

September 11, 2018

Status Verified

September 1, 2018

Enrollment Period

2.6 years

First QC Date

March 14, 2016

Last Update Submit

September 10, 2018

Conditions

Critical IllnessAcute Kidney InjuryEnd-stage Renal DiseaseRenal Replacement TherapyProton Pump Inhibitor

Outcome Measures

Primary Outcomes (1)

  • The proportion of patients with clinically important GI bleeding

    90 days or length of ICU stay, as applicable

Secondary Outcomes (8)

  • 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

    90 days or length of ICU stay, as applicable

  • Proportion of patients with serious adverse reactions

    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

    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

    90 days or length of ICU stay, as applicable

  • 90-day and 1-year (365 days) mortality post-randomization

    90 days/365 days or length of ICU stay, as applicable

  • +3 more secondary outcomes

Study Arms (2)

Verum (pantoprazole)

EXPERIMENTAL
Drug: Pantoprazole

Placebo

PLACEBO COMPARATOR

0.9% saline

Drug: Saline 0.9% (matching placebo)

Interventions

PantoprazoleDRUG
Verum (pantoprazole)
Saline 0.9% (matching placebo)DRUG
Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • please refer to SUP-ICU (NCT02467621) trial

You may not qualify if:

  • please refer to SUP-ICU (NCT02467621) trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Rigshospitalet

Copenhagen, Denmark

Location

Dept. of Intensive Care Medicine, University of Bern,

Bern, 3010, Switzerland

Location

Related Publications (2)

  • Schefold JC, Krag M, Marker S, Perner A, Wetterslev J, Wise MP, Borthwick M, Bendel S, Keus F, Guttormsen AB, Lange T, Moller MH; the SUP-ICU investigators. Outcomes of Prophylactic Pantoprazole in Adult Intensive Care Unit Patients Receiving Dialysis: Results of a Randomized Trial. Am J Nephrol. 2019;50(4):312-319. doi: 10.1159/000502732. Epub 2019 Sep 3.

    PMID: 31480045DERIVED

  • Schefold JC, Perner A, Lange T, Wetterslev J, Wise MP, Borthwick M, Bendel S, Keus F, Guttormsen AB, Marker S, Krag M, Moller MH; SUP-ICU investigators. Effects of stress ulcer prophylaxis in adult ICU patients receiving renal replacement therapy (Sup-Icu RENal, SIREN): Study protocol for a pre-planned observational study. Trials. 2018 Jan 10;19(1):26. doi: 10.1186/s13063-017-2408-3.

    PMID: 29321041DERIVED

Related Links

MeSH Terms

Conditions

Critical IllnessAcute Kidney InjuryKidney Failure, Chronic

Interventions

PantoprazoleSodium Chloride

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesRenal Insufficiency, ChronicChronic Disease

Intervention Hierarchy (Ancestors)

2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
SIREN principle investigator

Study Record Dates

First Submitted

March 14, 2016

First Posted

March 24, 2016

Study Start

February 1, 2016

Primary Completion

September 1, 2018

Study Completion

September 1, 2018

Last Updated

September 11, 2018

Record last verified: 2018-09

Locations

DK(1)CH(1)