Evidence map›Paper›PMID 25583616›Full record

Trial reportIntensive care medicine2015

Protocolized fluid therapy in brain-dead donors: the multicenter randomized MOnIToR trial.

Ali Al-Khafaji, Michele Elder, Daniel J Lebovitz, Raghavan Murugan, Michael Souter, Susan Stuart, Abdus S Wahed, Ben Keebler, Dorrie Dils, Stephanie Mitchell and 4 more

Registry-linked trialOpen access · greenAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Intensive care medicine, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00987714 (Monitoring Organ Donors to Increase Transplantation Results), which is not on this map. Cited by 20 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed, 1 pooled it
7.9field-weighted citation impact, top 3% 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.

NCT00987714 nacompletednot on this map

Monitoring Organ Donors to Increase Transplantation Results

TypeinterventionalSponsorUniversity of PittsburghRan2009 to 2013Enrolled556ConditionsTransplantationArmsProtocolized care
3 · Its place in the literature

Who cites it

20 citing papers in PubMed, 1 synthesis or guideline pooled it, 71 citations in OpenAlex.

  1. Donor heart selection: Evidence-based guidelines for providers.The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation · 2023
    Guideline
  2. Article
  3. Article
  4. Article
  5. Article
  6. Article
  7. Review
  8. Article
  9. Expedited organ donation in Victoria, Australia: donor characteristics and donation outcomes.Critical care and resuscitation : journal of the Australasian Academy of Critical Care Medicine · 2020
    Article
  10. Review
  11. Article
  12. Review
  13. Article
  14. Review
  15. ICU Management of the Potential Organ Donor: State of the Art.Current neurology and neuroscience reports · 2016
    Review
  16. Organ-Protective Intensive Care in Organ Donors.Deutsches Arzteblatt international · 2016
    Review
  17. In support of 'usual' perioperative care.British journal of anaesthesia · 2016
    Article
  18. Review
  19. Article
  20. 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

14 authors at 7 institutions in 2 countries.

Ali Al-KhafajiCenter for Critical Care Nephrology, Department of Critical Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.
Michele Elder
Daniel J Lebovitz
Raghavan Murugan
Michael Souter
Susan Stuart
Abdus S Wahed
Ben Keebler
Dorrie Dils
Stephanie Mitchell
Kurt Shutterly
Dawn Wilkerson
Rupert Pearse
John A Kellum
University of Pittsburgh · USOrgan Recovery Systems (United States) · USAkron Children's Hospital · USHarborview Medical Center · USMethodist Hospital · USQueen Mary University of London · GBUniversity of Oklahoma Health Sciences Center · US

Funding

UNIVERSITY OF PITTSBURGH CLINICAL AND TRANSLATIONAL SCIENCE INSTITUTE: BPCAUL1RR024153 · NCRR · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI REIS, STEVEN E · 2006 to 2011
$73.9M
University of Pittsburgh Clinical and Translational Science InstituteUL1TR000005 · NCATS · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI REIS, STEVEN E · 2012 to 2015
$50.8M
Protocolized Goal-directed Resuscitation of Septic Shock to Prevent AKI (ProGReSSR01DK083961 · NIDDK · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI KELLUM, JOHN A · 2010 to 2013
$2.6M
Department of Health CS/08/08/17Department of Health RP_2014-04-022NCATS NIH HHS UL1 TR000005NCATS NIH HHS UL1TR000005NCRR NIH HHS UL1 RR024153NIDDK NIH HHS R01 DK083961NIDDK NIH HHS R01DK083961OSTLTS CDC HHS R38OT1058
6 · The paper itself

Abstract

backgroundCritical shortages of organs for transplantation jeopardize many lives. Observational data suggest that better fluid management for deceased organ donors could increase organ recovery. We conducted the first large multicenter randomized trial in brain-dead donors to determine whether protocolized fluid therapy increases the number of organs transplanted.

methodsWe randomly assigned donors to either protocolized or usual care in eight organ procurement organizations. A "protocol-guided fluid therapy" algorithm targeting the cardiac index, mean arterial pressure and pulse pressure variation was used. Our primary outcome was the number of organs transplanted per donor, and our primary analysis was intention to treat. Secondary analyses included: (1) modified intention to treat where only subjects able to receive the intervention were included and (2) 12-month survival in transplant recipients. The study was stopped early.

resultsWe enrolled 556 donors: 279 protocolized care and 277 usual care. Groups had similar characteristics at baseline. The study protocol could be implemented in 76 % of subjects randomized to the intervention. There was no significant difference in mean number of organs transplanted per donor: 3.39 organs per donor (95 % CI 3.14-3.63) with protocolized care compared to 3.29 usual care (95 % CI 3.04-3.54; mean difference, 0.1, 95 % CI -0.25 to 0.45; p = 0.56). In modified intention-to-treat analysis the mean number of organs increased (3.52 organs per donor, 95 % CI 3.23-3.8), but not statistically significantly (mean difference, 0.23, 95 % CI -0.15 to 0.61; p = 0.23). Among the 1,430 recipients of organs from study subjects with data available, 56 deaths (7.8 %) occurred in the protocolized care arm and 56 (7.9 %) in the usual care arm in the first year (hazard ratio: 0.97, p = 0.86).

conclusionsIn brain-dead organ donors, protocol-guided fluid therapy compared to usual care may not increase the number of organs transplanted per donor.

Indexed as

Brain DeathClinical ProtocolsTissue DonorsAdultFemaleFluid TherapyHemodynamicsHumansMaleMiddle AgedMonitoring, PhysiologicTissue and Organ Procurement

Identifiers

PMID25583616
PMCPMC4351113
OpenAlexW2074344143

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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.