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CompletedNCT03934892Updated May 2, 2019

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

An observational study in Cardiopulmonary Bypass and Lactate, sponsored by Hualien Tzu Chi General Hospital. Completed. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2019-05-02.

Sponsored by Hualien Tzu Chi General Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
97
Ages
18 Years to 90 Years
Sex
All
01

Study 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.

Read the 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.

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Conditions studied

  • Cardiopulmonary Bypass
  • Lactate
03

In context

Lead sponsor

Hualien Tzu Chi General Hospital is the lead sponsor of 5 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • patients with missing data from records
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
97 participants (actual)
Patient registry
No

Groups and cohorts

  • lactate during CPB

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

    Diagnostic Test: serum lactate

Interventions

  • Diagnostic testserum lactate

    check lactate levels during cardiopulmonary bypass in adult cardiac operations

06

What researchers measure

Primary outcomes

  1. in-hospital mortality

    peak lactate level during cardiopulmonary bypass predicts in-hospital mortality

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

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • 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. PubMed 11156124 ↗
  • 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. PubMed 22813486 ↗

Individual participant data

Plan to share: Undecided — The individual participant data (IPD) will be available on request.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 2, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03934892
Lead sponsor
Hualien Tzu Chi General Hospital
Responsible party
Yi-Tso Cheng (Director, Hualien Tzu Chi General Hospital) — Principal investigator
First posted
May 2, 2019
Start date
Jan 1, 2015
Primary completion
Dec 31, 2018
Completion
Dec 31, 2018
Last update
May 2, 2019

Study contacts

Yi-tso Cheng, MD
study chair · Hualien Tzu Chi General Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.

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