NCT03934892

Brief Summary

Tissue hypoperfusion during cardiopulmonary bypass (CPB) affects cardiac surgical outcomes. Lactate, an end product of anaerobic glycolysis from oxygen deficit, is an obtainable marker of tissue hypoxia. The investigators aimed to determine the value of blood lactate level during CPB in adult cardiac surgeries in predicting outcomes. The investigators retrospectively reviewed the patients underwent cardiac surgeries with CPB from January 2015 to December 2015. The patient's characteristics, pre-operative status, surgical type, and intra-operative lactate levels were collected. The outcomes were in-hospital mortality and complications. Receiver operating characteristics (ROC) curves were used to assess the ability of peak lactate level during CPB to predict in-hospital mortality.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
97

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2015

Longer than P75 for all trials

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, 2015

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 24, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 2, 2019

Completed
Last Updated

May 2, 2019

Status Verified

April 1, 2019

Enrollment Period

4 years

First QC Date

April 24, 2019

Last Update Submit

April 30, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • in-hospital mortality

    peak lactate level during cardiopulmonary bypass predicts in-hospital mortality

    From date of inclusion until date of death from any cause during hospitalization, assessed up to one year

Study Arms (1)

lactate during CPB

check lactate levels routinely during cardiac operations with cardiopulmonary bypass, choose the peak lactate data

Diagnostic Test: serum lactate

Interventions

serum lactateDIAGNOSTIC_TEST

check lactate levels during cardiopulmonary bypass in adult cardiac operations

lactate during CPB

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

adults patients underwent cardiac surgeries with cardiopulmonary bypass from January 2015 to December 2015

You may qualify if:

  • adults patients underwent cardiac surgeries with cardiopulmonary bypass from January 2015 to December 2015

You may not qualify if:

  • patients with missing data from records

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Demers P, Elkouri S, Martineau R, Couturier A, Cartier R. Outcome with high blood lactate levels during cardiopulmonary bypass in adult cardiac operation. Ann Thorac Surg. 2000 Dec;70(6):2082-6. doi: 10.1016/s0003-4975(00)02160-3.

  • O'Connor E, Fraser JF. The interpretation of perioperative lactate abnormalities in patients undergoing cardiac surgery. Anaesth Intensive Care. 2012 Jul;40(4):598-603. doi: 10.1177/0310057X1204000404.

Study Officials

  • Yi-tso Cheng, MD

    Hualien Tzu Chi General Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

April 24, 2019

First Posted

May 2, 2019

Study Start

January 1, 2015

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

May 2, 2019

Record last verified: 2019-04