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

Coronary Artery Occlusive Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04654663
• Other study ID #: 4-2020-1128
• Status: Completed
• Start date: December 7, 2020
• Est. completion date: January 15, 2021

Study information

• Verified date: July 2021
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 605
• Est. completion date: January 15, 2021
• Est. primary completion date: January 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Occlusive Disease
• Sarcopenia

Locations

Country	Name	City	State
Korea, Republic of	Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postoperative pulmonary complications : pneumonia	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.	During the hospitalization for surgery. This includes the entire postoperative period up to discharge, even if over 30 days.
Primary	postoperative pulmonary complications : prolonged ventilation	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.	During the hospitalization for surgery. This includes the entire postoperative period up to discharge, even if over 30 days.
Primary	postoperative pulmonary complications : reintubation	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.	During the hospitalization for surgery. This includes the entire postoperative period up to discharge, even if over 30 days.
Secondary	postoperative complications : Renal failure	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.	During the hospitalization for surgery. This includes the entire postoperative period up to discharge, even if over 30 days.
Secondary	postoperative complications : Delirium	Indicate whether the patient experienced postoperative delirium from OR Exit to ICU discharge.	During the hospitalization for surgery. This includes the entire postoperative period up to discharge, even if over 30 days.
Secondary	postoperative complications : Reoperation due to bleeding/tamponade	Indicate whether the patient was reexplored for mediastinal bleeding with or without tamponade either in the ICU or returned to the operating room.	During the hospitalization for surgery. This includes the entire postoperative period up to discharge, even if over 30 days.
Secondary	postoperative complications : Permanent stroke	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.	During the hospitalization for surgery. This includes the entire postoperative period up to discharge, even if over 30 days.
Secondary	postoperative complications : Mortality	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)	During the hospitalization in which the operation was performed, even if after 30 days.
Secondary	postoperative complications : Mortality	all deaths, regardless of cause, occurring after discharge from the hospital, but before the end of the 30th postoperative day.	After discharge from the hospital, but before the end of the 30th postoperative day.