Evidence map›Paper›PMID 29321041›Full record

ArticleTrials2018

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.

Joerg C Schefold, Anders Perner, Theis Lange, Jørn Wetterslev, Matt P Wise, Mark Borthwick, Stepani Bendel, Frederik Keus, Anne Berit Guttormsen, Søren Marker and 3 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02718261 (Sup-Icu RENal), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.7field-weighted citation impact, top 32% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02718261 phase4completednot on this map

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

TypeinterventionalSponsorInsel Gruppe AG, University Hospital BernRan2016 to 2018Enrolled3,350ConditionsCritical Illness, Acute Kidney Injury, End-stage Renal Disease, Renal Replacement TherapyArmsPantoprazole, Saline 0.9% (matching placebo)
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 4 citations in OpenAlex.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors at 8 institutions in 6 countries.

Joerg C SchefoldDepartment of Intensive Care Medicine, Inselspital, Bern University Hospital, University of Bern, Freiburgstrasse 18, CH 3010, Bern, Switzerland. joerg.schefold@insel.ch.
Anders PernerDepartment of Intensive Care 4131, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.
Theis LangeSection of Biostatistics, University of Copenhagen, Copenhagen, Denmark.
Jørn WetterslevCopenhagen Trial Unit, Centre for Clinical Intervention Research, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark.
Matt P WiseDepartment of Adult Critical Care, University Hospital of Wales, Cardiff, UK.
Mark BorthwickPharmacy Department, Oxford University Hospitals NHS Trust, Oxford, UK.
Stepani BendelDepartment of Intensive Care Medicine, Kuopio University Hospital, Kuopio, Finland.
Frederik KeusDepartment of Critical Care, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.
Anne Berit GuttormsenDepartment of Anaesthesia and Intensive Care, Haukeland University Hospital and Clinical Institute 1 UiB, Bergen, Norway.
Søren MarkerDepartment of Intensive Care 4131, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.
Mette KragDepartment of Intensive Care 4131, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.
Morten Hylander MøllerDepartment of Intensive Care 4131, Copenhagen University Hospital, Rigshospitalet, Blegdamsvej 9, Copenhagen, 2100, Denmark.
SUP-ICU investigators
Copenhagen University Hospital · DKUniversity Hospital of Wales · GBUniversity Medical Center Groningen · NLUniversity of Copenhagen · DKHaukeland University Hospital · NOKuopio University Hospital · FIUniversity Hospital of Bern · CHUniversity of Bern · CH

Funding

Wissenschaftlicher Fonds, Dept. of Intensive Care Medicine, University of Bern does not apply
6 · The paper itself

Abstract

backgroundProton pump inhibitors are often used in critically ill patients to prevent gastrointestinal bleeding despite limited evidence for benefit. Patients with acute kidney injury requiring renal replacement therapy (RRT) are at high risk of gastrointestinal bleeding as (pre-)uremia induces coagulopathy through effects on platelets and coagulation cascades. No high-quality randomized clinical trials have previously assessed the benefits and harms of prophylactic proton pump inhibitor use in this high-risk population of adult critically ill patients. METHODS/

designAmong the 3350 patients included in the Stress Ulcer Prophylaxis in the Intensive Care Unit (SUP-ICU) trial-an investigator-initiated international randomized clinical trial on prophylactic proton pump inhibitor versus placebo in acutely admitted adult ICU patients at risk of gastrointestinal bleeding-we will compare the benefits and harms of prophylactic use of proton pump inhibitor in patients in need of RRT versus those not requiring this treatment. We will determine the proportion of patients with clinically important bleeding, the proportion of patients with adverse events including pneumonia, Clostridium difficile enteritis, or acute myocardial ischemia in the ICU, as well as transfusion requirements. Moreover, 90 day and 365 day mortality post-randomization will be investigated. As a secondary analysis, we will examine the association between acute kidney injury and RRT during ICU stay and gastrointestinal bleeding. DISCUSSION: With the outlined predefined analysis, we will characterize the balance between the benefits and harms of stress ulcer prophylaxis in acutely admitted adult ICU patients in need of RRT, including the potential interaction of allocation to proton pump inhibitor versus placebo.

trial registrationClinicalTrials.gov, NCT02718261 . Registered on 14 March 2016.

Indexed as

Intensive Care UnitsRenal Replacement TherapyAcute Kidney InjuryGastrointestinal HemorrhageHumansMulticenter Studies as TopicObservational Studies as TopicOutcome Assessment, Health CarePeptic UlcerPragmatic Clinical Trials as TopicProton Pump InhibitorsStress, PsychologicalProton Pump InhibitorsAcute kidney injuryAcute renal failureDialysisPantoprazoleSepsis

Identifiers

PMID29321041
PMCPMC5763643
OpenAlexW2783508807

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.