Cardiopulmonary BypassNCT03934892
Prognostic Value of Peak Lactate During Cardiopulmonary Bypass in Adult Cardiac Surgeries
An observational study of Cardiopulmonary Bypass and Lactate, run by Hualien Tzu Chi General Hospital.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Cardiopulmonary Bypass, Lactate
- What is being tested?
- serum lactate
- How many people
- 97 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2015to 31 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: adults patients underwent cardiac surgeries with cardiopulmonary bypass from January 2015 to December 2015
Who may be able to join
- adults patients underwent cardiac surgeries with cardiopulmonary bypass from January 2015 to December 2015
Who cannot join
- patients with missing data from records
About this study
Official title: 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.
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.
- Conditions
- Cardiopulmonary Bypass, Lactate
- Being tested
- serum lactate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
serum lactateDiagnostic test
check lactate levels during cardiopulmonary bypass in adult cardiac operations
| Study group | Role | What they receive |
|---|---|---|
| lactate during CPB | check lactate levels routinely during cardiac operations with cardiopulmonary bypass, choose the peak lactate data Receives: Diagnostic Test: serum lactate |
What is being measured
The primary outcome is the main question the study is designed to answer.
in-hospital mortality
peak lactate level during cardiopulmonary bypass predicts in-hospital mortality
Measured: From date of inclusion until date of death from any cause during hospitalization, assessed up to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2019
- Study start1 Jan 2015
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiopulmonary BypassStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hualien Tzu Chi General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yi-Tso Cheng, Hualien Tzu Chi General Hospital
- Investigators
- Yi-tso Cheng, MD, Study chair, Hualien Tzu Chi General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03934892
- Sponsor's protocol ID
- HualienTCGH
- Status last verified
- Apr 2019
- First submitted
- 24 Apr 2019
- Last updated
- 2 May 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The individual participant data (IPD) will be available on request.
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 11156124O'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
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Value of Peak Lactate During Cardiopulmonary Bypass in Adult Cardiac Surgeries: a Cohort Study
- ClinicalTrials.gov ID
- NCT03934892
- Acronym / sponsor ID
- HualienTCGH
- Conditions
- Cardiopulmonary Bypass, Lactate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Hualien Tzu Chi General HospitalUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 2 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| lactate during CPB | – | Diagnostic Test: serum lactatecheck lactate levels routinely during cardiac operations with cardiopulmonary bypass, choose the peak lactate data |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adults patients underwent cardiac surgeries with cardiopulmonary bypass from January 2015 to December 2015
Key inclusion criteria (1 listed)
- adults patients underwent cardiac surgeries with cardiopulmonary bypass from January 2015 to December 2015
Key exclusion criteria (1 listed)
- patients with missing data from records
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| serum lactatecheck lactate levels during cardiopulmonary bypass in adult cardiac operations | Diagnostic test | lactate during CPB |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2019.
- Results publication: PubMed 11156124Demers 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.
- Results publication: PubMed 22813486O'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.
- Individual participant dataSharing planned: Undecided. The individual participant data (IPD) will be available on request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yi-tso Cheng, MD study chair
Hualien Tzu Chi General Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiopulmonary Bypass and Lactate, run by Hualien Tzu Chi General Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 May 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
in-hospital mortality (time frame: From date of inclusion until date of death from any cause during hospitalization, assessed up to one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03934892, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2019.