Risks of Adverse Events After Cardiac SurgeryPRAECSNCT04476134
The Perioperative Risks of Adverse Events After Cardiac Surgery: a Retrospective Study
An observational study of Risks of Adverse Events After Cardiac Surgery, run by Lei Du at 1 site in China.
Trial summary
Cardiac surgeries under cardiopulmonary bypass (CPB) are a major treatment for heart valve disease and coronary artery disease, and over 1-1.25 million such procedures are performed annually worldwide. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Risks of Adverse Events After Cardiac Surgery
- How many people
- 10,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2018to Mar 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing cardiac surgery under CPB at West China Hospital of Sichuan University between January 1, 2011 and June 30, 2017 and the Second Affiliated Hospital in the School of Medicine of Zhejiang University between September 1, 2013 and June 30, 2017 will be enrolled, because those hospitals launched electronic medical record systems on January 1, 2011 and September 1, 2013, respectively.
Who may be able to join
- Age ≥ 18 years
- Valve replacement or/and coronary artery bypass graft surgery under CPB
Who cannot join
- Combined surgery involving ascending aortic replacement surgery or cardiac tumor resection
- Emergency surgery (defined as surgery performed before the end of the same workday as admission);
- Died on the operating table, or could not be weaned off CPB;
- Medical data missing
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
West China Hospital of Sichuan University
Chengdu, Sichuan, 610041
Weimin Li, M.D
About this study
Cardiac surgeries under cardiopulmonary bypass (CPB) are a major treatment for heart valve disease and coronary artery disease, and over 1-1.25 million such procedures are performed annually worldwide. These procedures are associated with mortality rates of 0.9-4.0% and morbidity rates up to 45.9%.The analysis of perioperative risk factors for these adverse events can provide beneficial help for improving the prognosis of patients undergoing cardiac surgery.Patients undergoing cardiac surgery under CPB at West China Hospital of Sichuan University between January 1, 2011 and June 30, 2017 and the Second Affiliated Hospital in the School of Medicine of Zhejiang University between September 1, 2013 and June 30, 2017 will be enrolled,and demographic data, preoperative and intraoperative data, and postoperative adverse events were collected.Independent perioperative risk factors of death, organ injury and other adverse events in cardiac surgery patients under CPB were studied by univariate and multivariate Logistic regression analysis to provide evidence for prevention and intervention in clinic.
Read the detailed description
- Anesthesia management The standard procedures of anesthesia and CPB in the two institutions were applied as described (49, 50). Briefly, anesthesia was induced with midazolam, sufentanil, muscle relaxant and/or etomidate, and maintained by continuous remifentanil infusion and sevoflurane inhalation, combined with intermittent muscle relaxant and sufentanil intravenous injection.
- CPB management CPB involved a roll pump, a membrane oxygenator, a filter and connecting tubes and was primed with colloid solution of 1000 mL and 500 ml crystalline liquid. During CPB, blood flow was at 2.0-2.4 L/m2/min to maintain mean arterial pressure at 50-80 mmHg. Cold 4:1 blood cardioplegia was used for heart arrest. During CPB, nasopharyngeal temperature was maintained at 32-340C during these procedures and moderate hemodilution was used. All patients received an initial heparin dose of 375 U/kg to achieve systemic anticoagulation, and additional heparin was intermittently injected to maintain activated clotting time longer than 480 s during CPB. After weaning from CPB, heparin was neutralized with protamine in a 1:1 ratio based on the initial heparin dose.
- Data Collection Form (DCF) In order to minimize the role of potential confounders on adverse outcomes, we will do a systematic search for "risk factor, predictor, adverse outcome, mortality, morbidity, complications, and cardiac surgery" using EMBASE, Cochrane and PubMed databases from Jan 1, 2000 to Dec 31, 2015. All the perioperative potential risk factors mentioned in these studies will be on the DCF.
- Data collection All variables in the DCF will be retrieved from the Hospital Electronic Medical Record System and medical records. If information on a certain variable cannot be acquired, it will be recorded as ☒. For example, there may be no record of the hemoglobin level on the fifth day after surgery, so we will write ☒ in brackets on the fifth day hemoglobin value. After the data collection is finished, the investigators will sign their names on the first page of the DCF.
- Data Checking Two supervisors will check data promptly. If data are doubted, they will send their questions to the first investigator. According to the Schedule of Events, an "X" will be recorded after the data are confirmed to be correct. Once the whole DCF is completed, the supervisors sign their names and send the DCF to the statisticians.
- Data Input Data will be input by one statistician using EpiDate3.0 (Odense, Denmark, http://www.epidata.dk/), and another independent statistician will confirm this procedure. Then the CRFs will be stored sequentially.
- Quality control and quality assurance Diagnosis must be performed strictly according to pre-established definitions. All data in the DCF will be inspected promptly and correctly in order to guarantee reliability. All procedures in this study will be performed by two independent researchers.
- Statistical analysis Data analysis will be carried out by experienced biostatisticians.Categorical variables are expressed as frequencies (percentages), and compared between patient groups using the chi-squared or Fisher's exact tests. Shapiro-Wilk tests are used to determine the distribution of continuous variables. Normally distributed data are reported as mean ± standard deviation (SD), and compared between groups using one-way ANOVA test. Skewed data are expressed as median [interquartile range (IQR)] and compared between groups using Wilcoxon rank sum tests. The incidence of complications between groups will be performed with the chi-squared test or Fisher's exact tests. Logistic regression analysis will be performed to evaluate risk factors for complications.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| patients with adverse events | patients underwent adverse events after cardiac surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
death
all-cause death
Measured: up to 30 days
postoperative complications
complications after the cardiac surgery
Measured: up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2020
- Study start1 Jan 2018
- Primary completionOct 2020 (estimated)
- Study completionMar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Risks of Adverse Events After Cardiac SurgeryStudies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lei Du
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lei Du, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04476134
- Sponsor's protocol ID
- WestChinaH-2018-01
- Acronym
- PRAECS
- Status last verified
- Jul 2020
- First submitted
- 13 Jul 2020
- Last updated
- 17 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Because this research is ongoing,and individual participant data involve privacy of patients,we have not decided whether sharing data with other researchers.
Publications
Dixon B, Santamaria JD, Reid D, Collins M, Rechnitzer T, Newcomb AE, Nixon I, Yii M, Rosalion A, Campbell DJ. The association of blood transfusion with mortality after cardiac surgery: cause or confounding? (CME). Transfusion. 2013 Jan;53(1):19-27. doi: 10.1111/j.1537-2995.2012.03697.x. Epub 2012 May 11.
PubMed 22574710Pearse RM, Moreno RP, Bauer P, Pelosi P, Metnitz P, Spies C, Vallet B, Vincent JL, Hoeft A, Rhodes A; European Surgical Outcomes Study (EuSOS) group for the Trials groups of the European Society of Intensive Care Medicine and the European Society of Anaesthesiology. Mortality after surgery in Europe: a 7 day cohort study. Lancet. 2012 Sep 22;380(9847):1059-65. doi: 10.1016/S0140-6736(12)61148-9.
PubMed 22998715Ghali WA, Ash AS, Hall RE, Moskowitz MA. Statewide quality improvement initiatives and mortality after cardiac surgery. JAMA. 1997 Feb 5;277(5):379-82.
PubMed 9010169Bridgewater B. Almanac 2012 adult cardiac surgery: the National Society Journals present selected research that has driven recent advances in clinical cardiology. Hellenic J Cardiol. 2013 Jan-Feb;54(1):5-14.
PubMed 23340123Raiten JM, Ghadimi K, Augoustides JG, Ramakrishna H, Patel PA, Weiss SJ, Gutsche JT. Atrial fibrillation after cardiac surgery: clinical update on mechanisms and prophylactic strategies. J Cardiothorac Vasc Anesth. 2015;29(3):806-16. doi: 10.1053/j.jvca.2015.01.001. No abstract available.
PubMed 26009291Maganti MD, Rao V, Borger MA, Ivanov J, David TE. Predictors of low cardiac output syndrome after isolated aortic valve surgery. Circulation. 2005 Aug 30;112(9 Suppl):I448-52. doi: 10.1161/CIRCULATIONAHA.104.526087.
PubMed 16159861Kuitunen A, Vento A, Suojaranta-Ylinen R, Pettila V. Acute renal failure after cardiac surgery: evaluation of the RIFLE classification. Ann Thorac Surg. 2006 Feb;81(2):542-6. doi: 10.1016/j.athoracsur.2005.07.047.
PubMed 16427848Haase M, Bellomo R, Matalanis G, Calzavacca P, Dragun D, Haase-Fielitz A. A comparison of the RIFLE and Acute Kidney Injury Network classifications for cardiac surgery-associated acute kidney injury: a prospective cohort study. J Thorac Cardiovasc Surg. 2009 Dec;138(6):1370-6. doi: 10.1016/j.jtcvs.2009.07.007. Epub 2009 Sep 5.
PubMed 19733864McDonagh DL, Berger M, Mathew JP, Graffagnino C, Milano CA, Newman MF. Neurological complications of cardiac surgery. Lancet Neurol. 2014 May;13(5):490-502. doi: 10.1016/S1474-4422(14)70004-3. Epub 2014 Apr 2.
PubMed 24703207Lomivorotov VV, Efremov SM, Kirov MY, Fominskiy EV, Karaskov AM. Low-Cardiac-Output Syndrome After Cardiac Surgery. J Cardiothorac Vasc Anesth. 2017 Feb;31(1):291-308. doi: 10.1053/j.jvca.2016.05.029. Epub 2016 Jul 29. No abstract available.
PubMed 27671216Cheng Z, Wang Y, Liu J, Ming Y, Yao Y, Wu Z, Guo Y, Du L, Yan M. A novel model for predicting a composite outcome of major complications after valve surgery. Front Cardiovasc Med. 2023 May 17;10:1132428. doi: 10.3389/fcvm.2023.1132428. eCollection 2023.
PubMed 37265563
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Perioperative Risks of Adverse Events After Cardiac Surgery: a Retrospective Study
- ClinicalTrials.gov ID
- NCT04476134
- Acronym / sponsor ID
- PRAECS / WestChinaH-2018-01
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Lei DuUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- Oct 2020 (estimated)
- Study completion
- Mar 2021 (estimated)
- First posted
- 17 Jul 2020 (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.
Cardiac surgeries under cardiopulmonary bypass (CPB) are a major treatment for heart valve disease and coronary artery disease, and over 1-1.25 million such procedures are performed annually worldwide. These procedures are associated with mortality rates of 0.9-4.0% and morbidity rates up to 45.9%.The analysis of perioperative risk factors for these adverse events can provide beneficial help for improving the prognosis of patients undergoing cardiac surgery.Patients undergoing cardiac surgery under CPB at West China Hospital of Sichuan University between January 1, 2011 and June 30, 2017 and the Second Affiliated Hospital in the School of Medicine of Zhejiang University between September 1, 2013 and June 30, 2017 will be enrolled,and demographic data, preoperative and intraoperative data, and postoperative adverse events were collected.Independent perioperative risk factors of death, organ injury and other adverse events in cardiac surgery patients under CPB were studied by univariate and multivariate Logistic regression analysis to provide evidence for prevention and intervention in clinic.
Detailed description
- Anesthesia management The standard procedures of anesthesia and CPB in the two institutions were applied as described (49, 50). Briefly, anesthesia was induced with midazolam, sufentanil, muscle relaxant and/or etomidate, and maintained by continuous remifentanil infusion and sevoflurane inhalation, combined with intermittent muscle relaxant and sufentanil intravenous injection.
- CPB management CPB involved a roll pump, a membrane oxygenator, a filter and connecting tubes and was primed with colloid solution of 1000 mL and 500 ml crystalline liquid. During CPB, blood flow was at 2.0-2.4 L/m2/min to maintain mean arterial pressure at 50-80 mmHg. Cold 4:1 blood cardioplegia was used for heart arrest. During CPB, nasopharyngeal temperature was maintained at 32-340C during these procedures and moderate hemodilution was used. All patients received an initial heparin dose of 375 U/kg to achieve systemic anticoagulation, and additional heparin was intermittently injected to maintain activated clotting time longer than 480 s during CPB. After weaning from CPB, heparin was neutralized with protamine in a 1:1 ratio based on the initial heparin dose.
- Data Collection Form (DCF) In order to minimize the role of potential confounders on adverse outcomes, we will do a systematic search for "risk factor, predictor, adverse outcome, mortality, morbidity, complications, and cardiac surgery" using EMBASE, Cochrane and PubMed databases from Jan 1, 2000 to Dec 31, 2015. All the perioperative potential risk factors mentioned in these studies will be on the DCF.
- Data collection All variables in the DCF will be retrieved from the Hospital Electronic Medical Record System and medical records. If information on a certain variable cannot be acquired, it will be recorded as ☒. For example, there may be no record of the hemoglobin level on the fifth day after surgery, so we will write ☒ in brackets on the fifth day hemoglobin value. After the data collection is finished, the investigators will sign their names on the first page of the DCF.
- Data Checking Two supervisors will check data promptly. If data are doubted, they will send their questions to the first investigator. According to the Schedule of Events, an "X" will be recorded after the data are confirmed to be correct. Once the whole DCF is completed, the supervisors sign their names and send the DCF to the statisticians.
- Data Input Data will be input by one statistician using EpiDate3.0 (Odense, Denmark, http://www.epidata.dk/), and another independent statistician will confirm this procedure. Then the CRFs will be stored sequentially.
- Quality control and quality assurance Diagnosis must be performed strictly according to pre-established definitions. All data in the DCF will be inspected promptly and correctly in order to guarantee reliability. All procedures in this study will be performed by two independent researchers.
- Statistical analysis Data analysis will be carried out by experienced biostatisticians.Categorical variables are expressed as frequencies (percentages), and compared between patient groups using the chi-squared or Fisher's exact tests. Shapiro-Wilk tests are used to determine the distribution of continuous variables. Normally distributed data are reported as mean ± standard deviation (SD), and compared between groups using one-way ANOVA test. Skewed data are expressed as median [interquartile range (IQR)] and compared between groups using Wilcoxon rank sum tests. The incidence of complications between groups will be performed with the chi-squared test or Fisher's exact tests. Logistic regression analysis will be performed to evaluate risk factors for complications.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with adverse events | – | –patients underwent adverse events after cardiac surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing cardiac surgery under CPB at West China Hospital of Sichuan University between January 1, 2011 and June 30, 2017 and the Second Affiliated Hospital in the School of Medicine of Zhejiang University between September 1, 2013 and June 30, 2017 will be enrolled, because those hospitals launched electronic medical record systems on January 1, 2011 and September 1, 2013, respectively.
Key inclusion criteria (2 listed)
- Age ≥ 18 years
- Valve replacement or/and coronary artery bypass graft surgery under CPB
Key exclusion criteria (4 listed)
- Combined surgery involving ascending aortic replacement surgery or cardiac tumor resection
- Emergency surgery (defined as surgery performed before the end of the same workday as admission);
- Died on the operating table, or could not be weaned off CPB;
- Medical data missing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
death
Time frame: up to 30 days
all-cause death
postoperative complications
Time frame: up to 30 days
complications after the cardiac surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2020.
- Results publication: PubMed 22574710Dixon B, Santamaria JD, Reid D, Collins M, Rechnitzer T, Newcomb AE, Nixon I, Yii M, Rosalion A, Campbell DJ. The association of blood transfusion with mortality after cardiac surgery: cause or confounding? (CME). Transfusion. 2013 Jan;53(1):19-27. doi: 10.1111/j.1537-2995.2012.03697.x. Epub 2012 May 11.
- Results publication: PubMed 22998715Pearse RM, Moreno RP, Bauer P, Pelosi P, Metnitz P, Spies C, Vallet B, Vincent JL, Hoeft A, Rhodes A; European Surgical Outcomes Study (EuSOS) group for the Trials groups of the European Society of Intensive Care Medicine and the European Society of Anaesthesiology. Mortality after surgery in Europe: a 7 day cohort study. Lancet. 2012 Sep 22;380(9847):1059-65. doi: 10.1016/S0140-6736(12)61148-9.
- Results publication: PubMed 9010169Ghali WA, Ash AS, Hall RE, Moskowitz MA. Statewide quality improvement initiatives and mortality after cardiac surgery. JAMA. 1997 Feb 5;277(5):379-82.
- Results publication: PubMed 23340123Bridgewater B. Almanac 2012 adult cardiac surgery: the National Society Journals present selected research that has driven recent advances in clinical cardiology. Hellenic J Cardiol. 2013 Jan-Feb;54(1):5-14.
- Results publication: PubMed 26009291Raiten JM, Ghadimi K, Augoustides JG, Ramakrishna H, Patel PA, Weiss SJ, Gutsche JT. Atrial fibrillation after cardiac surgery: clinical update on mechanisms and prophylactic strategies. J Cardiothorac Vasc Anesth. 2015;29(3):806-16. doi: 10.1053/j.jvca.2015.01.001. No abstract available.
- Results publication: PubMed 16159861Maganti MD, Rao V, Borger MA, Ivanov J, David TE. Predictors of low cardiac output syndrome after isolated aortic valve surgery. Circulation. 2005 Aug 30;112(9 Suppl):I448-52. doi: 10.1161/CIRCULATIONAHA.104.526087.
- Results publication: PubMed 16427848Kuitunen A, Vento A, Suojaranta-Ylinen R, Pettila V. Acute renal failure after cardiac surgery: evaluation of the RIFLE classification. Ann Thorac Surg. 2006 Feb;81(2):542-6. doi: 10.1016/j.athoracsur.2005.07.047.
- Results publication: PubMed 19733864Haase M, Bellomo R, Matalanis G, Calzavacca P, Dragun D, Haase-Fielitz A. A comparison of the RIFLE and Acute Kidney Injury Network classifications for cardiac surgery-associated acute kidney injury: a prospective cohort study. J Thorac Cardiovasc Surg. 2009 Dec;138(6):1370-6. doi: 10.1016/j.jtcvs.2009.07.007. Epub 2009 Sep 5.
- Results publication: PubMed 24703207McDonagh DL, Berger M, Mathew JP, Graffagnino C, Milano CA, Newman MF. Neurological complications of cardiac surgery. Lancet Neurol. 2014 May;13(5):490-502. doi: 10.1016/S1474-4422(14)70004-3. Epub 2014 Apr 2.
- Results publication: PubMed 27671216Lomivorotov VV, Efremov SM, Kirov MY, Fominskiy EV, Karaskov AM. Low-Cardiac-Output Syndrome After Cardiac Surgery. J Cardiothorac Vasc Anesth. 2017 Feb;31(1):291-308. doi: 10.1053/j.jvca.2016.05.029. Epub 2016 Jul 29. No abstract available.
- Derived from this study: PubMed 37265563Cheng Z, Wang Y, Liu J, Ming Y, Yao Y, Wu Z, Guo Y, Du L, Yan M. A novel model for predicting a composite outcome of major complications after valve surgery. Front Cardiovasc Med. 2023 May 17;10:1132428. doi: 10.3389/fcvm.2023.1132428. eCollection 2023.
- Individual participant dataSharing planned: Undecided. Because this research is ongoing,and individual participant data involve privacy of patients,we have not decided whether sharing data with other researchers.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Risks of Adverse Events After Cardiac Surgery, run by Lei Du at 1 site in China.
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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 17 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lei Du, M.D (18980601926, dulei@scu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
death (time frame: up to 30 days). The study lists 2 primary outcomes in all. 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 NCT04476134, which also lists 11 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 17 Jul 2020.