Evidence map›Paper›PMID 29514697›Full record

ArticleTrials2018

Cardiac output Optimisation following Liver Transplant (COLT) trial: study protocol for a feasibility  randomised controlled trial.

Farid Froghi, Rahul Koti, Kurinchi Gurusamy, Susan Mallett, Douglas Thorburn, Linda Selves, Sarah James, Jeshika Singh, Manuel Pinto, Christine Eastgate and 6 more

Open 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. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
1.2field-weighted citation impact, top 22% 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

0 citing papers in PubMed, 7 citations in OpenAlex.

No citing paper in PubMed yet.

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

16 authors at 4 institutions in 1 country.

Farid FroghiDivision of Surgery and Interventional Science, University College London, London, UK.ORCID http://orcid.org/0000-0002-2895-117X
Rahul KotiDivision of Surgery and Interventional Science, University College London, London, UK.
Kurinchi GurusamyDivision of Surgery and Interventional Science, University College London, London, UK.
Susan MallettCritical Care Unit, Royal Free Hospital, London, NW3 2QG, UK.
Douglas ThorburnInstitute for Liver and Digestive Health, University College London, London, UK.
Linda SelvesInstitute for Liver and Digestive Health, University College London, London, UK.
Sarah JamesCritical Care Unit, Royal Free Hospital, London, NW3 2QG, UK.
Jeshika SinghHealth Economic Research Group, Brunel University, London, UK.
Manuel PintoCritical Care Unit, Royal Free Hospital, London, NW3 2QG, UK.
Christine EastgateCritical Care Unit, Royal Free Hospital, London, NW3 2QG, UK.
Margaret McNeilCritical Care Unit, Royal Free Hospital, London, NW3 2QG, UK.
Helder FilipeCritical Care Unit, Royal Free Hospital, London, NW3 2QG, UK.
Fatima JichiBiostatistics Group, Joint Research Office, University College London, London, UK.
Nick SchofieldRoyal Free Perioperative Research Group (RoFPoR), Royal Free Hospital, London, UK.
Daniel MartinDivision of Surgery and Interventional Science, University College London, London, UK. daniel.martin@ucl.ac.uk.
Brian DavidsonDivision of Surgery and Interventional Science, University College London, London, UK.
The Royal Free Hospital · GBUniversity College London · GBBrunel University of London · GBUniversity College Hospital · GB

Funding

Department of Health HTA/13/153/04Department of Health PB-PG-0214-33043National Institute for Health Research PB-PG-0214-33043
6 · The paper itself

Abstract

backgroundPatients with liver cirrhosis undergoing liver transplantation have a hyperdynamic circulation which persists into the early postoperative period making accurate assessment of fluid requirements challenging. Goal-directed fluid therapy (GDFT) has been shown to reduce morbidity and mortality in a number of surgery settings. The impact of GDFT in patients undergoing liver transplantation is unknown. A feasibility trial was designed to determine patient and clinician support for recruitment into a randomised controlled trial of GDFT following liver transplantation, adherence to a GDFT protocol, participant withdrawal, and to determine appropriate endpoints for a subsequent larger trial to evaluate the efficacy of GDFT in patients undergoing liver transplantation.

methodsThe Cardiac output Optimisation following Liver Transplant (COLT) trial is designed as a prospective, single-centre, randomised controlled study to assess the feasibility and safety of GDFT in liver transplantation for patients with cirrhosis. Consenting adults (aged between 18 and 80 years) with biopsy-proven liver cirrhosis who have been selected to undergo a first liver transplantation will be included in the trial and randomised into GDFT or standard care starting immediately after surgery and continuing for the first 12 h thereafter. Both groups will have cardiac output and stroke volume monitored using the FloTrac (EV1000) device. The intervention will consist of a protocolised GDFT approach to patient management, using stroke volume optimisation. The control group will receive standard care, without stroke volume and cardiac output measurement. After 12 h the patient's fluid management will revert to standard of care. The primary endpoint of this study is feasibility. Secondary endpoints will include a safety assessment of the intervention, graft and patient survival, liver function, postoperative complications graded by Clavien-Dindo criteria, length of intensive care and hospital stay and quality of life across the intervention and control groups. DISCUSSION: There is a growing body of evidence that the use of perioperative GDFT in surgical patients can improve outcomes; however, signals of harm have also been detected. Patients with liver cirrhosis undergoing liver transplantation have markedly different cardiovascular physiology than general surgical patients. If GDFT is proven to be feasible and safe in this patient group, then a multicentre trial to demonstrate efficacy and cost-effectiveness will be required.

trial registrationInternational Standard Randomised Controlled Trial Registry, ID: ISRCTN10329248. Registered on 4 April 2016.

Indexed as

Cardiac OutputLiver TransplantationAdolescentAdultAgedAged, 80 and overBiopsyFeasibility StudiesFemaleFluid TherapyHumansInfusions, IntravenousLiver CirrhosisLondonMaleMiddle AgedRinger's LactateCardiac outputFluid therapyLiver transplantationPerioperative care

Identifiers

PMID29514697
PMCPMC5842525
OpenAlexW2797705319

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.