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NCT Number: NCT03889730

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

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.

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. Duration of mechanical ventilation after surgery

    Time frame: Up to 30 days after surgery

    Duration of mechanical ventilation after surgery

  3. Length of stay in hospital after surgery

    Time frame: Up to 30 days after surgery

    Length of stay in hospital after surgery

  4. 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

  5. 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.

  6. 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.

  7. All-cause mortality in hospital

    Time frame: Up to 30 days after surgery

    All-cause mortality in hospital

Sponsors and collaborators

Lead sponsor

Peking University First Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Mar 26, 2019
Registry last updated
Jul 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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