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NCT Number: NCT04654663

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

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.

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Key information

Conditions

Coronary Artery Occlusive Disease

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

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

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 60)
  • Patients with acute kidney injury
  • Patients with respiratory tract infection within 1 month before surgery

Treatment and study plan

Primary outcomes

  1. postoperative pulmonary complications : pneumonia

    Time frame: 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

    Time frame: 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

    Time frame: 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 outcomes

  1. postoperative complications : Renal failure

    Time frame: 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:

    • 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Official study title

Impact of Sarcopenia Index on Postoperative Pulmonary Complication in Elderly Patients Undergoing OPCAB: a Retrospective Study

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 4, 2020
Registry last updated
Jul 28, 2021

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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