Coronary Artery Occlusive DiseaseNCT04654663
Impact of Sarcopenia Index on Postoperative Pulmonary Complication in Elderly Patients Undergoing OPCAB
An observational study of Coronary Artery Occlusive Disease, run by Yonsei University at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Coronary Artery Occlusive Disease
- How many people
- 605 participants
- Where
- 1 siteSouth Korea
- Study dates
- 7 Dec 2020to 15 Jan 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: patients who undersent off-pump coronary artery bypass graft surgery.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
Seoul
About this study
Official title: Impact of Sarcopenia Index on Postoperative Pulmonary Complication in Elderly Patients Undergoing OPCAB: a Retrospective Study
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.
- Conditions
- Coronary Artery Occlusive Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During the hospitalization for surgery. This includes the entire postoperative period up to discharge, even if over 30 days.
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.
Measured: During the hospitalization for surgery. This includes the entire postoperative period up to discharge, even if over 30 days.
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.
Measured: During the hospitalization for surgery. This includes the entire postoperative period up to discharge, even if over 30 days.
Secondary outcomes (6)
postoperative complications : Renal failure
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.
Measured: During the hospitalization for surgery. This includes the entire postoperative period up to discharge, even if over 30 days.
postoperative complications : Delirium
Indicate whether the patient experienced postoperative delirium from OR Exit to ICU discharge.
Measured: During the hospitalization for surgery. This includes the entire postoperative period up to discharge, even if over 30 days.
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.
Measured: During the hospitalization for surgery. This includes the entire postoperative period up to discharge, even if over 30 days.
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.
Measured: During the hospitalization for surgery. This includes the entire postoperative period up to discharge, even if over 30 days.
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)
Measured: During the hospitalization in which the operation was performed, even if after 30 days.
postoperative complications : Mortality
all deaths, regardless of cause, occurring after discharge from the hospital, but before the end of the 30th postoperative day.
Measured: After discharge from the hospital, but before the end of the 30th postoperative day.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2020
- Study start7 Dec 2020
- Primary completion15 Jan 2021
- Study completion15 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery Occlusive DiseaseStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 605 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Young-Lan Kwak, MD, PhD, Principal investigator, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04654663
- Sponsor's protocol ID
- 4-2020-1128
- Status last verified
- Jul 2021
- First submitted
- 29 Nov 2020
- Last updated
- 28 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Sarcopenia Index on Postoperative Pulmonary Complication in Elderly Patients Undergoing OPCAB: a Retrospective Study
- ClinicalTrials.gov ID
- NCT04654663
- Acronym / sponsor ID
- 4-2020-1128
- Conditions
- Coronary Artery Occlusive Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 605 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 7 Dec 2020 (actual)
- Primary completion
- 15 Jan 2021 (actual)
- Study completion
- 15 Jan 2021 (actual)
- First posted
- 4 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- patients who undersent off-pump coronary artery bypass graft surgery.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
6 secondary outcomes
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.
postoperative complications : Delirium
Time frame: During the hospitalization for surgery. This includes the entire postoperative period up to discharge, even if over 30 days.
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.
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.
postoperative complications : Mortality
Time frame: During the hospitalization in which the operation was performed, even if after 30 days.
postoperative complications : Mortality
Time frame: After discharge from the hospital, but before the end of the 30th postoperative day.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Young-Lan Kwak, MD, PhD principal investigator
Severance Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Occlusive Disease, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2021.