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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03934892
Other study ID # HualienTCGH
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2015
Est. completion date December 31, 2018

Study information

Verified date April 2019
Source Hualien Tzu Chi General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 97
Est. completion date December 31, 2018
Est. primary completion date December 31, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
serum lactate
check lactate levels during cardiopulmonary bypass in adult cardiac operations

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Hualien Tzu Chi General Hospital

References & 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. — View Citation

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. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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