Dynamic Characterization of Postoperative Recovery After Cardiac Surgery

Postoperative Recovery Clinical Trial

Official title:

Dynamic Characterization of Postoperative Recovery After Cardiac Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05782036
• Other study ID #: 2022-1882
• Status: Recruiting
• Start date: April 1, 2023
• Est. completion date: October 30, 2024

Study information

• Verified date: February 2023
• Source: China National Center for Cardiovascular Diseases
• Contact: zhe zheng
• Phone: 010-88396051
• Email: zhengzhe[@]fuwai.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: October 30, 2024
• Est. primary completion date: October 30, 2023
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Postoperative Recovery

Locations

Country	Name	City	State
China	Fuwai hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
China National Center for Cardiovascular Diseases

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	EQ-5D results		1 year post operative
Secondary	In-hospital mortality	Occurrence of death during hospitalization	From surgery to discharge, up to 7 days
Secondary	In-hospital stroke	Occurrence of stroke during hospitalization	From surgery to discharge, up to 7 days
Secondary	In-hospital myocardial infarction	Occurrence of myocardial infarction during hospitalization	From surgery to discharge, up to 7 days
Secondary	In-hospital acute renal failure	Occurrence of acute renal failure during hospitalization	From surgery to discharge, up to 7 days
Secondary	In-hospital sternal wound infection	Occurrence of sternal wound infection during hospitalization	From surgery to discharge, up to 7 days
Secondary	In-hospital reoperation	Occurrence of reoperation during hospitalization	From surgery to discharge, up to 7 days
Secondary	Length of hospital stay	Length of hospital stay	Approximately 7 days
Secondary	1-year major adverse events	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)	1 year post operative