NCT04476134

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

July 13, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 17, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
Last Updated

July 17, 2020

Status Verified

July 1, 2020

Enrollment Period

2.8 years

First QC Date

July 13, 2020

Last Update Submit

July 15, 2020

Conditions

Risks of Adverse Events After Cardiac Surgery

Outcome Measures

Primary Outcomes (2)

  • death

    all-cause death

    up to 30 days

  • postoperative complications

    complications after the cardiac surgery

    up to 30 days

Study Arms (1)

patients with adverse events

patients underwent adverse events after cardiac surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • Age ≥ 18 years
  • Valve replacement or/and coronary artery bypass graft surgery under CPB

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

West China Hospital of Sichuan University

Chengdu, Sichuan, 610041, China

RECRUITING

Related Publications (11)

  • 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.

    PMID: 22574710RESULT

  • Pearse 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.

    PMID: 22998715RESULT

  • Ghali WA, Ash AS, Hall RE, Moskowitz MA. Statewide quality improvement initiatives and mortality after cardiac surgery. JAMA. 1997 Feb 5;277(5):379-82.

    PMID: 9010169RESULT

  • Bridgewater 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.

    PMID: 23340123RESULT

  • Raiten 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.

    PMID: 26009291RESULT

  • Maganti 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.

    PMID: 16159861RESULT

  • Kuitunen 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.

    PMID: 16427848RESULT

  • Haase 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.

    PMID: 19733864RESULT

  • McDonagh 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.

    PMID: 24703207RESULT

  • Lomivorotov 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.

    PMID: 27671216RESULT

  • Cheng 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.

    PMID: 37265563DERIVED

Central Study Contacts

Lei Du, M.D

CONTACT

18980601926dulei@scu.edu.cn

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

July 13, 2020

First Posted

July 17, 2020

Study Start

January 1, 2018

Primary Completion

October 1, 2020

Study Completion

March 1, 2021

Last Updated

July 17, 2020

Record last verified: 2020-07

Locations

CN(1)