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NCT02565329 Clinical Trial

Serum Lactate Trend in Liver Resection

Lactase Persistence Clinical Trial

Official title:
Serum Lactate Trend in Liver Resection With Intermittent Pringle Maneuver: The "Square-Root" Shape

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02565329
Other study ID # LacClearance
Secondary ID
Status Completed
Phase N/A
First received September 23, 2015
Last updated September 29, 2015
Start date January 2014
Est. completion date February 2015

Study information
Verified date September 2015
Source University of Milan
Contact n/a
Is FDA regulated No
Health authority Italy: Ministry of Health
Study type Observational

Clinical Trial Summary

The study aimed to evaluate the correlation between the serum lactate concentration ed cumulative Pringle time after liver resection. In addition, the correlation between lactate clearance and clamping time was investigated.

Description:

During liver resection high serum lactate (sLac) concentration can be related to several clinical factors: impairment in lactate metabolism (i.e. extraction and utilization by the liver) or overproduction by splanchnic tissues; restrictive fluid regimen in order to limit the intraoperative back-flow bleeding; ischemia-reperfusion syndrome. However, the Pringle maneuver (temporary clamping of the hepatic hilum) seems having a sensible effect in inducing a significant increase in sLac levels during liver resection, particularly in the event of compromised liver function such as in cirrhosis.

Although the peak of sLac concentration may correlate with outcome, the lactate clearance (cLac) seems to be a better predictor. To date, this relationship has been mainly demonstrated in severe sepsis and shock septic. However, the effective correlation between the cumulative clamping time and cLac has not been clearly investigated. The correlation between cumulative hepatic ischemic time and sLac trend in the perioperative period after liver resection with intermittent PM was investigated.

Recruitment information / eligibility
Status Completed
Enrollment 133
Est. completion date February 2015
Est. primary completion date February 2015
Accepts healthy volunteers No
Gender Both
Age group 34 Years to 85 Years
Eligibility Inclusion Criteria:

- Patients scheduled for liver resection for hepatic tumors

Exclusion Criteria:

- Patients who received blood transfusion or affected by chronic renal failure were excluded

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

Locations
Country Name City State
Italy Department of Hepatobiliary and General Surgery, Humanitas Research Hospital, University of Milan Rozzano Milan

Sponsors (1)
Lead Sponsor Collaborator
University of Milan

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Serum lactate concentration trend after liver resection within the first 30 days after surgery Yes