Ignite Creation Date:
2025-12-24 @ 3:20 PM
Ignite Modification Date:
2026-02-09 @ 8:59 PM
Study NCT ID:
NCT03934892
Status:
COMPLETED
Last Update Posted:
2019-05-02
First Post:
2019-04-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prognostic Value of Peak Lactate During Cardiopulmonary Bypass in Adult Cardiac Surgeries
Sponsor:
Hualien Tzu Chi General Hospital
Organization:
Study Overview
Official Title:
Prognostic Value of Peak Lactate During Cardiopulmonary Bypass in Adult Cardiac Surgeries: a Cohort Study
Status:
COMPLETED
Status Verified Date:
2019-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: