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Perioperative Lactate Kinetics in Patient Undergoing Major Liver Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04512014
Recruitment Status : Completed
First Posted : August 13, 2020
Last Update Posted : August 13, 2020
Sponsor:
Information provided by (Responsible Party):
Popescu Mihai, Institutul Clinic Fundeni

Study Description
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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.

Condition or disease Intervention/treatment
Liver Failure, Acute Diagnostic Test: serum lactate

Study Design
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Study Type : Observational
Actual Enrollment : 55 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Evaluation of Lactate Levels in as a Risk Factor for Posthepatectomy Liver Failure
Actual Study Start Date : January 1, 2017
Actual Primary Completion Date : December 31, 2019
Actual Study Completion Date : December 31, 2019

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Groups and Cohorts
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Group/Cohort Intervention/treatment
major liver surgery
Patients undergoing major liver surgery
 Diagnostic Test: serum lactate
perioperative measurement of lactate levels


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  1. mortality [ Time Frame: 30 days mortality ]
    in hospital mortality


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
all patients undergoing major liver failure in our institution
Criteria

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)
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04512014


Locations
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Romania
Fundeni Clinical Institute
Bucharest, Romania, 022328
Sponsors and Collaborators
Institutul Clinic Fundeni
Investigators
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Study Chair: Dana Tomescu, Prof Fundeni Clinical Institute
More Information
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Responsible Party: Popescu Mihai, Clinical Professor, Institutul Clinic Fundeni
ClinicalTrials.gov Identifier: NCT04512014    
Other Study ID Numbers: Liver_lactate
First Posted: August 13, 2020    Key Record Dates
Last Update Posted: August 13, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Liver Failure
Hepatic Insufficiency
Liver Failure, Acute
Liver Diseases
Digestive System Diseases