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

Sponsor
Peking University First Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03889730
Collaborator
(none)
821
1
3.4
240.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    821 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Impact of Intraoperative Hypotension on Risk of Acute Kidney Injury After Off-pump Coronary Artery Bypass Grafting Surgery: A Retrospective Cohort Study
    Actual Study Start Date :
    Mar 3, 2019
    Actual Primary Completion Date :
    May 31, 2019
    Actual Study Completion Date :
    Jun 15, 2019

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of acute kidney injury (AKI) within 7 days after surgery [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 Outcome Measures

    1. Classification of AKI within 7 days after surgery [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 [Up to 30 days after surgery]

      Duration of mechanical ventilation after surgery

    3. Length of stay in hospital after surgery [Up to 30 days after surgery]

      Length of stay in hospital after surgery

    4. Length of stay in intensive care unit (ICU) after surgery [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 [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 [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 [Up to 30 days after surgery]

      All-cause mortality in hospital

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Peking University First Hospital Beijing Beijing China 100034

    Sponsors and Collaborators

    • Peking University First Hospital

    Investigators

    • Principal Investigator: Dong-Xin Wang, MD, PhD, Peking University First Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Dong-Xin Wang, Professor and Chairman, Department of Anaesthesiology and Critical Care Medicine, Peking University First Hospital
    ClinicalTrials.gov Identifier:
    NCT03889730
    Other Study ID Numbers:
    • OPCABG-AKI-BP
    First Posted:
    Mar 26, 2019
    Last Update Posted:
    Jul 18, 2019
    Last Verified:
    Jul 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Dong-Xin Wang, Professor and Chairman, Department of Anaesthesiology and Critical Care Medicine, Peking University First Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 18, 2019