Prognostic Value of Peak Lactate During Cardiopulmonary Bypass in Adult Cardiac Surgeries

April 30, 2019 updated by: Yi-Tso Cheng, Hualien Tzu Chi General Hospital

Prognostic Value of Peak Lactate During Cardiopulmonary Bypass in Adult Cardiac Surgeries: a Cohort Study

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.

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

The baseline characteristics, including age, gender, body mass index (BMI), comorbidities, left ventricular ejection fraction (LVEF, %), European system for cardiac operative risk evaluation II (EuroSCORE II), pre-operative hematocrit, and serum creatinine levels were recorded. The surgical type was classified as coronary artery bypass grafting (CABG), valve surgery, combined surgery including CABG and valve surgery, great vessel surgery including aortic dissection, and other surgeries. The priority of surgery was classified as elective, urgent, and emergent. The intra-operative variables included CPB time, aortic cross-clamp time, initial lactate level at the beginning of the operation, and the peak lactate level during CPB.

Study Type

Observational

Enrollment (Actual)

97

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • patients with missing data from records

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
lactate during CPB
check lactate levels routinely during cardiac operations with cardiopulmonary bypass, choose the peak lactate data
check lactate levels during cardiopulmonary bypass in adult cardiac operations

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
in-hospital mortality
Time Frame: From date of inclusion until date of death from any cause during hospitalization, assessed up to one year
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Yi-tso Cheng, MD, Hualien Tzu Chi General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2015

Primary Completion (ACTUAL)

December 31, 2018

Study Completion (ACTUAL)

December 31, 2018

Study Registration Dates

First Submitted

April 24, 2019

First Submitted That Met QC Criteria

April 30, 2019

First Posted (ACTUAL)

May 2, 2019

Study Record Updates

Last Update Posted (ACTUAL)

May 2, 2019

Last Update Submitted That Met QC Criteria

April 30, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • HualienTCGH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The individual participant data (IPD) will be available on request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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