Perioperative Lactate Kinetics in Patient Undergoing Major Liver Surgery

August 12, 2020 updated by: Popescu Mihai, Institutul Clinic Fundeni

Evaluation of Lactate Levels in as a Risk Factor for Posthepatectomy Liver Failure

Major liver surgery is associated with increased incidence of perioperative complications and increased mortality if these are not addressed quickly in a high dependency intensive care unit. Of these, posthepatectomy liver failure (PHLF) represents one of the most important cause of postoperative unfavourable outcome. The present study investigates the correlation between lactate levels and PHLF. Lactate levels were collected at six specific timepoints: preoperative, pre-dissection phase, post-dissection phase, end of surgery and 24-hours and 48-hours in the postoperative period.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

55

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Romania
      • Bucharest, Romania, 022328
        • Fundeni Clinical Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

all patients undergoing major liver failure in our institution

Description

Inclusion Criteria:

  • patients undergoing major liver surgery for primary or secondary tumours

Exclusion Criteria:

  • unsigned patient consent
  • death within 24 hours
  • need for perioperative renal replacement therapy
  • underlying liver disease (e.g. liver cirrhosis)
  • other causes of raised lactate levels (e.g. shock)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
major liver surgery
Patients undergoing major liver surgery
Diagnostic test: serum lactate
perioperative measurement of lactate levels

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
lactate levels (mmol/L) in patients with PHLF
Time Frame: early postoperative period (48 hours)
correlation of lactate levels with the diagnosis of PHLF
early postoperative period (48 hours)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
mortality
Time Frame: 30 days mortality
in hospital mortality
30 days mortality

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institutul Clinic Fundeni

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2017

Primary Completion (ACTUAL)

December 31, 2019

Study Completion (ACTUAL)

December 31, 2019

Study Registration Dates

First Submitted

August 10, 2020

First Submitted That Met QC Criteria

August 12, 2020

First Posted (ACTUAL)

August 13, 2020

Study Record Updates

Last Update Posted (ACTUAL)

August 13, 2020

Last Update Submitted That Met QC Criteria

August 12, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Liver_lactate

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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