Dynamic Characterization of Postoperative Recovery After Cardiac Surgery

Sponsor

China National Center for Cardiovascular Diseases (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05782036

Collaborator

(none)

600

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

With the improvement of surgical techniques and medical care levels, most cardiac surgery patients have a good prognosis, and the long-term postoperative survival rate of some surgical patients has not significantly differed from that of the general population. While cardiac surgery is traumatic for patients and has a long postoperative recovery cycle, the recovery of patients is equally of concern. Postoperative recovery is a complex concept involving multiple domains, including patients' physiological functions, mental health, and pain, etc. These states will not only continuously change over time, but also the situation of postoperative recovery in patients with different characteristics is very different. Accordingly, the investigators aim to characterize trajectories of patient recovery after cardiac surgery using PROMs. The investigators will conduct a prospective study to characterize trajectories of postoperative recovery in multiple domains after cardiac surgery.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Recovery

Study Design

Study Type:

Observational

Anticipated Enrollment :

600 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Dynamic Characterization of Postoperative Recovery After Cardiac Surgery

Anticipated Study Start Date :

Apr 1, 2023

Anticipated Primary Completion Date :

Oct 30, 2023

Anticipated Study Completion Date :

Oct 30, 2024

Outcome Measures

Primary Outcome Measures

EQ-5D results [1 year post operative]

Secondary Outcome Measures

In-hospital mortality [From surgery to discharge, up to 7 days]
Occurrence of death during hospitalization
In-hospital stroke [From surgery to discharge, up to 7 days]
Occurrence of stroke during hospitalization
In-hospital myocardial infarction [From surgery to discharge, up to 7 days]
Occurrence of myocardial infarction during hospitalization
In-hospital acute renal failure [From surgery to discharge, up to 7 days]
Occurrence of acute renal failure during hospitalization
In-hospital sternal wound infection [From surgery to discharge, up to 7 days]
Occurrence of sternal wound infection during hospitalization
In-hospital reoperation [From surgery to discharge, up to 7 days]
Occurrence of reoperation during hospitalization
Length of hospital stay [Approximately 7 days]
Length of hospital stay
1-year major adverse events [1 year post operative]
Occurrence of 1-year major adverse events (all-cause death, readmission, cardiac related readmission, stroke, myocardial infarction, acute renal failure, dialysis, atrial fibrillation, Peripheral vascular embolism, bleeding, heart failure)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Inclusion Criteria:

Elective cardiac surgery

Exclusion Criteria:

Emergency surgery
Age ≤ 18 years
Refuse to participate in this study
Duration of postoperative ventilation > 48 hours or other postoperative recovery data were not available

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

China National Center for Cardiovascular Diseases

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

China National Center for Cardiovascular Diseases

ClinicalTrials.gov Identifier:

NCT05782036

Other Study ID Numbers:

2022-1882

First Posted:

Mar 23, 2023

Last Update Posted:

Mar 23, 2023

Last Verified:

Feb 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Mar 23, 2023