NCT02565329

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
133

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2014

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 23, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 1, 2015

Completed
Last Updated

October 1, 2015

Status Verified

September 1, 2015

Enrollment Period

1.1 years

First QC Date

September 23, 2015

Last Update Submit

September 29, 2015

Conditions

Lactase Persistence

Outcome Measures

Primary Outcomes (1)

  • Serum lactate concentration trend after liver resection

    within the first 30 days after surgery

Eligibility Criteria

Age34 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

133 consecutive patients scheduled for liver resection for primary and secondary tumors

You may qualify if:

  • Patients scheduled for liver resection for hepatic tumors

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Hepatobiliary and General Surgery, Humanitas Research Hospital, University of Milan

Rozzano, Milan, 20089, Italy

Location

Study Officials

  • Guido Guido, Guido

    Humanitas Research Hospital, Humanitas University, via Manzoni 56, 20089 Milan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof Guido Torzilli, MD, PhD, FACS

Study Record Dates

First Submitted

September 23, 2015

First Posted

October 1, 2015

Study Start

January 1, 2014

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

October 1, 2015

Record last verified: 2015-09

Locations

IT(1)