Clinical trial NCT03889730: Intraoperative Hypotension and Acute Kidney Injury After Off-pump Coronary Artery Bypass Grafting Surgery
Official title: Impact of Intraoperative Hypotension on Risk of Acute Kidney Injury After Off-pump Coronary Artery Bypass Grafting Surgery: A Retrospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Bypass, Off-Pump
Intraoperative Hypotension
Acute Kidney Injury
Keywords: Coronary Artery Bypass, Off-Pump
Intraoperative Hypotension
Acute Kidney Injury
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
First posted: 2019-03-26
Enrollment: 821
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of acute kidney injury (AKI) within 7 days after surgery
timeFrame: Up to 7 days after surgery
Secondary outcomes:
measure: Classification of AKI within 7 days after surgery
timeFrame: Up to 7 days after surgery
measure: Duration of mechanical ventilation after surgery
timeFrame: Up to 30 days after surgery
measure: Length of stay in hospital after surgery
timeFrame: Up to 30 days after surgery
measure: Length of stay in intensive care unit (ICU) after surgery
timeFrame: Up to 30 days after surgery
measure: Incidence of major adverse cardiovascular events (MACEs) within 30 days after surgery
timeFrame: Up to 30 days after surgery
measure: Incidence of non-MACE complications within 30 days after surgery
timeFrame: Up to 30 days after surgery
measure: All-cause mortality in hospital
timeFrame: Up to 30 days after surgery
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
Study officials:
affiliation: Peking University First Hospital
name: Dong-Xin Wang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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