Evidence map›Paper›PMID 26810999›Full record

Trial reportBMJ open2016

ATTIRE: Albumin To prevenT Infection in chronic liveR failurE: study protocol for a single-arm feasibility trial.

Louise China, Nicola Muirhead, Simon S Skene, Zainib Shabir, Roel P H De Maeyer, Alexander A N Maini, Derek W Gilroy, Alastair J O'Brien

Open access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in BMJ open, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
0.9field-weighted citation impact, top 25% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 7 citations in OpenAlex.

  1. Article
  2. Immune Regulatory Mediators in Plasma from Patients With Acute Decompensation Are Associated With 3-Month Mortality.Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association · 2020
    Article
  3. Article
  4. Albumin Counteracts Immune-Suppressive Effects of Lipid Mediators in Patients With Advanced Liver Disease.Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association · 2018
    Article
  5. Administration of Albumin Solution Increases Serum Levels of Albumin in Patients With Chronic Liver Failure in a Single-Arm Feasibility Trial.Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association · 2018
    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

8 authors at 2 institutions in 1 country.

Louise ChinaDivision of Medicine, University College London (UCL), London, UK.ORCID http://orcid.org/0000-0001-5870-2310
Nicola MuirheadComprehensive Clinical Trials Unit, University College London (UCL), London, UK.
Simon S SkeneComprehensive Clinical Trials Unit, University College London (UCL), London, UK.ORCID http://orcid.org/0000-0002-7828-3122
Zainib ShabirComprehensive Clinical Trials Unit, University College London (UCL), London, UK.
Roel P H De MaeyerDivision of Medicine, University College London (UCL), London, UK.
Alexander A N MainiDivision of Medicine, University College London (UCL), London, UK.
Derek W GilroyDivision of Medicine, University College London (UCL), London, UK.
Alastair J O'BrienDivision of Medicine, University College London (UCL), London, UK.
University College London · GBMRC Clinical Trials Unit at UCL · GB

Funding

Department of HealthWellcome TrustWellcome Trust 164699
6 · The paper itself

Abstract

introductionCirculating prostaglandin E2 levels are elevated in acutely decompensated cirrhosis and have been shown to contribute to immune suppression. Albumin binds and inactivates this hormone. Human albumin solution could thus be repurposed as an immune restorative drug in these patients.This feasibility study aims to determine whether it is possible and safe to restore serum albumin to >30 g/L and maintain it at this level in patients admitted with acute decompensated cirrhosis using repeated 20% human albumin infusions according to daily serum albumin levels. METHODS AND ANALYSIS: Albumin To prevenT Infection in chronic liveR failurE (ATTIRE) stage 1 is a multicentre, open label dose feasibility trial. Patients with acutely decompensated cirrhosis admitted to hospital with a serum albumin of <30 g/L are eligible, subject to exclusion criteria. Daily intravenous human albumin solution will be infused, according to serum albumin levels, for up to 14 days or discharge in all patients. The primary end point is daily serum albumin levels for the duration of the treatment period and the secondary end point is plasma-induced macrophage dysfunction. The trial will recruit 80 patients. Outcomes will be used to assist with study design for an 866 patient randomised controlled trial at more than 30 sites across the UK. ETHICS AND DISSEMINATION: Research ethics approval was given by the London-Brent research ethics committee (ref: 15/LO/0104). The clinical trials authorisation was issued by the medicines and healthcare products regulatory agency (ref: 20363/0350/001-0001).

resultsWill be disseminated through peer reviewed journals and international conferences. Recruitment of the first participant occurred on 26/05/2015. TRIAL REGISTRATION NUMBER: The trial is registered with the European Medicines Agency (EudraCT 2014-002300-24) and has been adopted by the NIHR (ISRCTN 14174793). This manuscript refers to V.4.0 of the protocol; Pre-results.

Indexed as

AdultAgedAlbuminsClinical ProtocolsCross InfectionCytokinesEnd Stage Liver DiseaseFeasibility StudiesHumansInfusions, IntravenousLiver CirrhosisMacrophagesMiddle AgedSerum AlbuminTreatment OutcomeYoung AdultAlbuminsCytokinesSerum AlbuminAlbuminLiver CirrhosisProstaglandin E2

Identifiers

PMID26810999
PMCPMC4735307
OpenAlexW2306272522

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.