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OpenTrials
Completed

NCT Number: NCT04512014

Perioperative Lactate Kinetics in Patient Undergoing Major Liver Surgery

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.

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Key information

Conditions

Liver Failure, Acute Digestive System Diseases Hepatic Insufficiency Liver Diseases Liver Failure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fundeni Clinical Institute

Bucharest, 022328, Romania

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

serum lactate

Diagnostic Test

perioperative measurement of lactate levels

Primary outcomes

  1. lactate levels (mmol/L) in patients with PHLF

    Time frame: early postoperative period (48 hours)

    correlation of lactate levels with the diagnosis of PHLF

Secondary outcomes

  1. mortality

    Time frame: 30 days mortality

    in hospital mortality

Sponsors and collaborators

Lead sponsor

Institutul Clinic Fundeni

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Aug 13, 2020
Registry last updated
Aug 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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