Evidence map›Paper›PMID 41712212›Full record

Trial reportJAMA network open2026

Albumin Replacement Therapy in Septic Shock: A Randomized Clinical Trial.

Yasser Sakr, Axel Nierhaus, Ulrike Schumacher, Stefan Utzolino, Ulrich Jaschinski, Sirak Petros, Falk Fichtner, Christine Eimer, Christian Putensen, Ivan Tanev and 8 more

Erratum issued Registry-linked trialAbstract readRandomized Controlled TrialMulticenter Study
In one paragraph

Trial report in JAMA network open, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT03869385 (Randomised Controlled Multicentre Study of Albumin Replacement Therapy in Septic Shock), which is not on this map. Cited by 13 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 3 pooled it
–field-weighted citation impact
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.

NCT03869385 phase3terminatednot on this map

Randomised Controlled Multicentre Study of Albumin Replacement Therapy in Septic Shock

TypeinterventionalSponsorJena University HospitalRan2019 to 2023Enrolled440ConditionsSeptic ShockArmsAlbutein® 200 g/L or Plasbumin® 20
3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Article
  5. Article
  6. Review
  7. Review
  8. Review
  9. Error in Methods.JAMA network open · 2026
    Article
  10. Review
  11. Article
  12. Review
  13. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

18 authors.

Yasser SakrDepartment of Anesthesiology and Intensive Care Therapy, Jena University Hospital, Jena, Germany.
Axel NierhausDepartment of Intensive Care Medicine, Hamburg-Eppendorf University Hospital, Hamburg, Germany.
Ulrike SchumacherCenter for Clinical Studies, Jena University Hospital, Jena, Germany.
Stefan UtzolinoDepartment of General Surgery, Surgical Intensive Care Unit, Freiburg University Hospital, Freiburg, Germany.
Ulrich JaschinskiDepartment of Anesthesiology and Surgical Intensive Care Therapy, Augsburg University Hospital, Augsburg, Germany.
Sirak PetrosInterdisciplinary Medical Intensive Care Unit, Leipzig University Hospital, Leipzig, Germany.
Falk FichtnerDepartment of Anesthesiology and Intensive Care Therapy, Leipzig University Hospital, Leipzig, Germany.
Christine EimerDepartment of Anesthesiology and Intensive Care Medicine, University Medical Center Schleswig-Holstein, Campus Kiel, Kiel, Germany.
Christian PutensenDepartment of Anesthesiology and Surgical Intensive Care, Bonn University Hospital, Bonn, Germany.
Ivan TanevDepartment of Cardiology and Angiology, Magdeburg University Hospital, Magdeburg, Germany.
Lukas KreienbühlDepartment of Anesthesiology, Critical Care, & Perioperative Pain Management, Helios Klinikum, Bad Saarow, Germany.
Stefan KlugeDepartment of Intensive Care Medicine, Hamburg-Eppendorf University Hospital, Hamburg, Germany.
Lampros KousoulasDepartment of General Surgery, Surgical Intensive Care Unit, Freiburg University Hospital, Freiburg, Germany.
Sven-Olaf KuhnDepartment of Anesthesiology, Intensive Care, Emergency and Pain Medizin, Klinik für Anästhesie, Intensiv-, Notfall- und Schmerzmedizin, Greifswald University Hospital, Greifswald, Germany.
Dominik JarczakDepartment of Intensive Care Medicine, Hamburg-Eppendorf University Hospital, Hamburg, Germany.
Michael QuintelDepartment of Anesthesiology, University Medical Center Göttingen, Göttingen, Germany.
Michael BauerDepartment of Anesthesiology and Intensive Care Therapy, Jena University Hospital, Jena, Germany.
SepNet Critical Care Trials Group and Albumin Replacement Therapy in Septic Shock (ARISS) investigators

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Importance: Albumin supplementation may reduce mortality in patients with septic shock; however, data from randomized clinical trials are limited. Objective: To assess the impact of albumin administration on outcomes in patients with septic shock. Design, Setting, and Participants: This multicenter, open-label randomized clinical trial was conducted between October 21, 2019, and May 2, 2022. Patients from 23 intensive care units in Germany enrolled within 24 hours of the onset of septic shock were followed up for outcome data up to 90 days. The statistical trial report was completed and filed with the federal authorities in December 2023; additional analyses were completed in October 2024. The study was terminated prematurely due to low enrollment rates. Interventions: Protocol group patients received 20% albumin to maintain serum albumin levels of at least 3.0 g/dL for up to 28 days during their intensive care unit admission. The control group received standard fluid administration with crystalloids. Main Outcomes and Measures: The primary end point was 90-day mortality; secondary end points included 28-day, 60-day, intensive care unit and in-hospital mortality, organ dysfunction or failure, total amount of fluid administration and total fluid balance while in the intensive care unit, duration of intensive care and hospital stays, and frequency of adverse events. Results: Of 440 randomized patients (median [IQR] age, 69 [59-78] years; 290 [65.9%] male), 222 received albumin and 218 received standard fluids. Baseline characteristics were comparable. Ninety-day mortality was 43.3% (91 of 210) in the albumin group vs 45.9% (96 of 209) in controls (relative risk, 0.94; 95% CI, 0.76-1.17; P = .71). No significant differences were observed for secondary end points. Conclusions and Relevance: In this randomized clinical trial of patients with septic shock, albumin administration was safe but did not improve 90-day survival. As this trial was prematurely terminated, results remain inconclusive and additional studies are recommended. Trial Registration: ClinicalTrials.gov Identifier: NCT03869385.

Indexed as

AlbuminsFluid TherapyShock, SepticAgedFemaleGermanyHospital MortalityHumansIntensive Care UnitsMaleMiddle AgedTreatment OutcomeAlbumins

Identifiers

PMID41712212
PMCPMC12921518

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.