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

July 16, 2019 updated by: Dong-Xin Wang, Peking University First Hospital

Impact of Intraoperative Hypotension on Risk of Acute Kidney Injury After Off-pump Coronary Artery Bypass Grafting Surgery: A Retrospective Cohort Study

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.

Study Overview

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

821

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Beijing
      • Beijing, Beijing, China, 100034
        • Peking University First Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of acute kidney injury (AKI) within 7 days after surgery
Time Frame: Up to 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of stay in hospital after surgery
Time Frame: Up to 30 days after surgery
Length of stay in hospital after surgery
Up to 30 days after surgery
Duration of mechanical ventilation after surgery
Time Frame: Up to 30 days after surgery
Duration of mechanical ventilation after surgery
Up to 30 days after surgery
Classification of AKI within 7 days after surgery
Time Frame: Up to 7 days after surgery
Development of AKI within 7 days after surgery is diagnosed according to the KDIGO criteria
Up to 7 days after surgery
Length of stay in intensive care unit (ICU) after surgery
Time Frame: 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
Time Frame: Up to 30 days after surgery
MACEs within 30 days after surgery include cardiovascular death, non-fatal cardiac arrest, acute myocardial infarction, revascularization, and ischemic stroke.
Up to 30 days after surgery
Incidence of non-MACE complications within 30 days after surgery
Time Frame: Up to 30 days after surgery
Non-MACE complications within 30 days after surgery indicate new-onset medical conditions other than MACEs that produce harmful effects on patients' recovery and required therapeutic intervention.
Up to 30 days after surgery
All-cause mortality in hospital
Time Frame: Up to 30 days after surgery
All-cause mortality in hospital
Up to 30 days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 3, 2019

Primary Completion (ACTUAL)

May 31, 2019

Study Completion (ACTUAL)

June 15, 2019

Study Registration Dates

First Submitted

March 23, 2019

First Submitted That Met QC Criteria

March 23, 2019

First Posted (ACTUAL)

March 26, 2019

Study Record Updates

Last Update Posted (ACTUAL)

July 18, 2019

Last Update Submitted That Met QC Criteria

July 16, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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