NCT04512014

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 10, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 13, 2020

Completed
Last Updated

August 13, 2020

Status Verified

August 1, 2020

Enrollment Period

3 years

First QC Date

August 10, 2020

Last Update Submit

August 12, 2020

Conditions

Liver Failure, Acute

Outcome Measures

Primary Outcomes (1)

  • lactate levels (mmol/L) in patients with PHLF

    correlation of lactate levels with the diagnosis of PHLF

    early postoperative period (48 hours)

Secondary Outcomes (1)

  • mortality

    30 days mortality

Study Arms (1)

major liver surgery

Patients undergoing major liver surgery

Diagnostic Test: serum lactate

Interventions

serum lactateDIAGNOSTIC_TEST

perioperative measurement of lactate levels

major liver surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

all patients undergoing major liver failure in our institution

You may qualify if:

  • patients undergoing major liver surgery for primary or secondary tumours

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fundeni Clinical Institute

Bucharest, 022328, Romania

Location

MeSH Terms

Conditions

Liver Failure, Acute

Condition Hierarchy (Ancestors)

Liver FailureHepatic InsufficiencyLiver DiseasesDigestive System Diseases

Study Officials

  • Dana Tomescu, Prof

    Fundeni Clinical Institute

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

August 10, 2020

First Posted

August 13, 2020

Study Start

January 1, 2017

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

August 13, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations

RO(1)