Intraoperative Hypotension and Acute Kidney Injury After Off-pump Coronary Artery Bypass Grafting Surgery

NCT ID: NCT03889730

Last Updated: 2019-07-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

821 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-03-03

Study Completion Date

2019-06-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Acute renal injury (AKI) is a common complication after cardiac surgery and is associated with worse outcomes. Hypotension is an important risk factor for the development of AKI after noncardiac surgery. However, the association between intraoperative hypotension and AKI after cardiac surgery has not been fully investigated. The purpose of this study is to analyze the association between intraoperative hypotension and acute kidney injury after off-pump coronary artery bypass surgery.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Acute renal injury (AKI) is a common complication after cardiac surgery. Cardiac surgery-associated acute kidney injury (CSA-AKI) is associated with increased in-hospital mortality, prolonged length of stay in the Intensive Care Unit and hospital, and higher costs of care. Intraoperative hypotension is an important risk factor for the development of AKI after noncardiac surgery. In a retrospective analysis, a mean arterial pressure of less than 55 mmHg predicted the occurrence of adverse cardiac- and renal-related outcomes after noncardiac surgery. Other studies also revealed that intraoperative hypotension is associated with increased incidence of AKI and 1-year mortality after noncardiac surgery. In patients undergoing cardiac surgery, 30-day mortality is proportionate to the extent of systolic blood pressure excursions outside the range of 75 to 135 mm Hg intraoperatively. However, the correlation between intraoperative hypotension and the development of AKI after cardiac surgery has not been fully investigated. The purpose of this study is to analyze the association between intraoperative hypotension and the risk of acute kidney injury after off-pump coronary artery bypass surgery.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Coronary Artery Bypass, Off-Pump Intraoperative Hypotension Acute Kidney Injury

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Age ≥ 50 years;
* Underwent off-pump CABG surgery.

Exclusion Criteria

* End-stage renal disease requiring renal-replacement therapy;
* Emergency surgery;
* Kidney transplantation within 3 months;
* Missing data.
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Peking University First Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Dong-Xin Wang

Professor and Chairman, Department of Anaesthesiology and Critical Care Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Dong-Xin Wang, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Peking University First Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Peking University First Hospital

Beijing, Beijing Municipality, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

References

Explore related publications, articles, or registry entries linked to this study.

Bove T, Monaco F, Covello RD, Zangrillo A. Acute renal failure and cardiac surgery. HSR Proc Intensive Care Cardiovasc Anesth. 2009;1(3):13-21.

Reference Type BACKGROUND
PMID: 23439962 (View on PubMed)

Hobson CE, Yavas S, Segal MS, Schold JD, Tribble CG, Layon AJ, Bihorac A. Acute kidney injury is associated with increased long-term mortality after cardiothoracic surgery. Circulation. 2009 May 12;119(18):2444-53. doi: 10.1161/CIRCULATIONAHA.108.800011. Epub 2009 Apr 27.

Reference Type BACKGROUND
PMID: 19398670 (View on PubMed)

Ortega-Loubon C, Fernandez-Molina M, Carrascal-Hinojal Y, Fulquet-Carreras E. Cardiac surgery-associated acute kidney injury. Ann Card Anaesth. 2016 Oct-Dec;19(4):687-698. doi: 10.4103/0971-9784.191578.

Reference Type BACKGROUND
PMID: 27716701 (View on PubMed)

Coleman MD, Shaefi S, Sladen RN. Preventing acute kidney injury after cardiac surgery. Curr Opin Anaesthesiol. 2011 Feb;24(1):70-6. doi: 10.1097/ACO.0b013e3283422ebc.

Reference Type BACKGROUND
PMID: 21157303 (View on PubMed)

Sun LY, Wijeysundera DN, Tait GA, Beattie WS. Association of intraoperative hypotension with acute kidney injury after elective noncardiac surgery. Anesthesiology. 2015 Sep;123(3):515-23. doi: 10.1097/ALN.0000000000000765.

Reference Type BACKGROUND
PMID: 26181335 (View on PubMed)

Abbott TEF, Pearse RM, Archbold RA, Ahmad T, Niebrzegowska E, Wragg A, Rodseth RN, Devereaux PJ, Ackland GL. A Prospective International Multicentre Cohort Study of Intraoperative Heart Rate and Systolic Blood Pressure and Myocardial Injury After Noncardiac Surgery: Results of the VISION Study. Anesth Analg. 2018 Jun;126(6):1936-1945. doi: 10.1213/ANE.0000000000002560.

Reference Type BACKGROUND
PMID: 29077608 (View on PubMed)

Aronson S, Dyke CM, Levy JH, Cheung AT, Lumb PD, Avery EG, Hu MY, Newman MF. Does perioperative systolic blood pressure variability predict mortality after cardiac surgery? An exploratory analysis of the ECLIPSE trials. Anesth Analg. 2011 Jul;113(1):19-30. doi: 10.1213/ANE.0b013e31820f9231. Epub 2011 Feb 23.

Reference Type BACKGROUND
PMID: 21346163 (View on PubMed)

Bijker JB, van Klei WA, Vergouwe Y, Eleveld DJ, van Wolfswinkel L, Moons KG, Kalkman CJ. Intraoperative hypotension and 1-year mortality after noncardiac surgery. Anesthesiology. 2009 Dec;111(6):1217-26. doi: 10.1097/ALN.0b013e3181c14930.

Reference Type BACKGROUND
PMID: 19934864 (View on PubMed)

Schopka S, Diez C, Camboni D, Floerchinger B, Schmid C, Hilker M. Impact of cardiopulmonary bypass on acute kidney injury following coronary artery bypass grafting: a matched pair analysis. J Cardiothorac Surg. 2014 Jan 18;9:20. doi: 10.1186/1749-8090-9-20.

Reference Type BACKGROUND
PMID: 24438155 (View on PubMed)

Rosner MH, Okusa MD. Acute kidney injury associated with cardiac surgery. Clin J Am Soc Nephrol. 2006 Jan;1(1):19-32. doi: 10.2215/CJN.00240605. Epub 2005 Oct 19.

Reference Type BACKGROUND
PMID: 17699187 (View on PubMed)

Kheterpal S, Tremper KK, Heung M, Rosenberg AL, Englesbe M, Shanks AM, Campbell DA Jr. Development and validation of an acute kidney injury risk index for patients undergoing general surgery: results from a national data set. Anesthesiology. 2009 Mar;110(3):505-15. doi: 10.1097/ALN.0b013e3181979440.

Reference Type BACKGROUND
PMID: 19212261 (View on PubMed)

Kellum JA, Lameire N; KDIGO AKI Guideline Work Group. Diagnosis, evaluation, and management of acute kidney injury: a KDIGO summary (Part 1). Crit Care. 2013 Feb 4;17(1):204. doi: 10.1186/cc11454.

Reference Type BACKGROUND
PMID: 23394211 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

OPCABG-AKI-BP

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.