Perioperative Lactate Kinetics in Patient Undergoing Major Liver Surgery

Liver Failure, Acute Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04512014
• Other study ID #: Liver_lactate
• Status: Completed
• Start date: January 1, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: August 2020
• Source: Institutul Clinic Fundeni
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Hepatic Insufficiency
• Liver Failure
• Liver Failure, Acute

Intervention

Diagnostic Test:
• serum lactate
perioperative measurement of lactate levels

Locations

Country	Name	City	State
Romania	Fundeni Clinical Institute	Bucharest

Sponsors (1)

Lead Sponsor	Collaborator
Institutul Clinic Fundeni

Country where clinical trial is conducted

Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	lactate levels (mmol/L) in patients with PHLF	correlation of lactate levels with the diagnosis of PHLF	early postoperative period (48 hours)
Secondary	mortality	in hospital mortality	30 days mortality