NCT03889730

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
821

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

March 3, 2019

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

March 23, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 26, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2019

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2019

Completed
Last Updated

July 18, 2019

Status Verified

July 1, 2019

Enrollment Period

3 months

First QC Date

March 23, 2019

Last Update Submit

July 16, 2019

Conditions

Keywords

Coronary Artery Bypass, Off-PumpIntraoperative HypotensionAcute Kidney Injury

Outcome Measures

Primary Outcomes (1)

  • Incidence of acute kidney injury (AKI) within 7 days after surgery

    Development of AKI within 7 days after surgery is diagnosed according to the Kidney Disease Improving Global Outcomes (KDIGO) criteria

    Up to 7 days after surgery

Secondary Outcomes (7)

  • Classification of AKI within 7 days after surgery

    Up to 7 days after surgery

  • Duration of mechanical ventilation after surgery

    Up to 30 days after surgery

  • Length of stay in hospital after surgery

    Up to 30 days after surgery

  • Length of stay in intensive care unit (ICU) after surgery

    Up to 30 days after surgery

  • Incidence of major adverse cardiovascular events (MACEs) within 30 days after surgery

    Up to 30 days after surgery

  • +2 more secondary outcomes

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing off-pump coronry artery bypass grafting surgery from April 2012 to March 2018 in Peking University First Hospital

You may qualify if:

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

You may not qualify if:

  • End-stage renal disease requiring renal-replacement therapy;
  • Emergency surgery;
  • Kidney transplantation within 3 months;
  • Missing data.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

Location

Related Publications (12)

  • 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.

    PMID: 23439962BACKGROUND
  • 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.

    PMID: 19398670BACKGROUND
  • 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.

    PMID: 27716701BACKGROUND
  • 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.

    PMID: 21157303BACKGROUND
  • 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.

    PMID: 26181335BACKGROUND
  • 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.

    PMID: 29077608BACKGROUND
  • 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.

    PMID: 21346163BACKGROUND
  • 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.

    PMID: 19934864BACKGROUND
  • 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.

    PMID: 24438155BACKGROUND
  • 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.

    PMID: 17699187BACKGROUND
  • 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.

    PMID: 19212261BACKGROUND
  • 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.

    PMID: 23394211BACKGROUND

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Dong-Xin Wang, MD, PhD

    Peking University First Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Chairman, Department of Anaesthesiology and Critical Care Medicine

Study Record Dates

First Submitted

March 23, 2019

First Posted

March 26, 2019

Study Start

March 3, 2019

Primary Completion

May 31, 2019

Study Completion

June 15, 2019

Last Updated

July 18, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations