Impact of Sarcopenia Index on Postoperative Pulmonary Complication in Elderly Patients Undergoing OPCAB

Sponsor
Yonsei University (Other)
Overall Status
Completed
CT.gov ID
NCT04654663
Collaborator
(none)
605
1
1.3
472.2

Study Details

Study Description

Brief Summary

Retrospective data collection. The aim of this study is to determine the effect of preoperative sarcopenia index on postoperative pulmonary complications in elderly patients undergoing off-pump coronary artery bypass graft surgery.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    605 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Impact of Sarcopenia Index on Postoperative Pulmonary Complication in Elderly Patients Undergoing OPCAB: a Retrospective Study
    Actual Study Start Date :
    Dec 7, 2020
    Actual Primary Completion Date :
    Jan 15, 2021
    Actual Study Completion Date :
    Jan 15, 2021

    Outcome Measures

    Primary Outcome Measures

    1. postoperative pulmonary complications : pneumonia [During the hospitalization for surgery. This includes the entire postoperative period up to discharge, even if over 30 days.]

      CXR with at least one of the following: infiltrate, consolidation, cavitation;plus at least one of the following: fever >38 °C with no other cause, white cell count <4 or>12*109 litre-1, >70 yr of age with altered mental status with no other cause;-plus at least two of the following: new purulent/ changed sputum, increased secretions/suctioning, new/worse cough/dyspnoea/tachypnoea, rales/ bronchial breath sounds, worsening gas exchange.

    2. postoperative pulmonary complications : prolonged ventilation [During the hospitalization for surgery. This includes the entire postoperative period up to discharge, even if over 30 days.]

      Indicate whether the patient had prolonged post-operative pulmonary ventilation > 24.0 hours. The hours of postoperative ventilation time include OR exit until extubation, plus any additional hours following reintubation.

    3. postoperative pulmonary complications : reintubation [During the hospitalization for surgery. This includes the entire postoperative period up to discharge, even if over 30 days.]

      Indicate whether the patient was intubated for the first time after leaving the OR from the initial procedure, or re-intubated during the hospital stay after the initial extubation.

    Secondary Outcome Measures

    1. postoperative complications : Renal failure [During the hospitalization for surgery. This includes the entire postoperative period up to discharge, even if over 30 days.]

      Indicate whether the patient had acute renal failure or worsening renal function resulting in ONE OR BOTH of the following: 1. Increase in serum creatinine level 3.0 x greater than baseline, or serum creatinine level ≥4 mg/dL , Acute rise must be at least 0.5 mg/dl 2. A new requirement for dialysis postoperatively.

    2. postoperative complications : Delirium [During the hospitalization for surgery. This includes the entire postoperative period up to discharge, even if over 30 days.]

      Indicate whether the patient experienced postoperative delirium from OR Exit to ICU discharge.

    3. postoperative complications : Reoperation due to bleeding/tamponade [During the hospitalization for surgery. This includes the entire postoperative period up to discharge, even if over 30 days.]

      Indicate whether the patient was reexplored for mediastinal bleeding with or without tamponade either in the ICU or returned to the operating room.

    4. postoperative complications : Permanent stroke [During the hospitalization for surgery. This includes the entire postoperative period up to discharge, even if over 30 days.]

      Indicate whether the patient has a postoperative stroke (i.e., any confirmed neurological deficit of abrupt onset caused by a disturbance in blood supply to the brain) that was confirmed on imaging or did not resolve within 24 hours.

    5. postoperative complications : Mortality [During the hospitalization in which the operation was performed, even if after 30 days.]

      all deaths, regardless of cause, occurring during the hospitalization in which the operation was performed, even if after 30 days (including patients transferred to other acute care facilities)

    6. postoperative complications : Mortality [After discharge from the hospital, but before the end of the 30th postoperative day.]

      all deaths, regardless of cause, occurring after discharge from the hospital, but before the end of the 30th postoperative day.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    65 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients who were 65 years of age or older at the time of surgery(off-pump coronary artery bypass graft surgery)

    • serum cystatin C and creatinine test results were valid within one week before surgery

    Exclusion Criteria:
    • Patients with chronic renal failure (estimated glomerular filtration rate less than
    • Patients with acute kidney injury

    • Patients with respiratory tract infection within 1 month before surgery

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine Seoul Korea, Republic of

    Sponsors and Collaborators

    • Yonsei University

    Investigators

    • Principal Investigator: Young-Lan Kwak, MD, PhD, Severance Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yonsei University
    ClinicalTrials.gov Identifier:
    NCT04654663
    Other Study ID Numbers:
    • 4-2020-1128
    First Posted:
    Dec 4, 2020
    Last Update Posted:
    Jul 28, 2021
    Last Verified:
    Jul 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 28, 2021