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Clinical Trials/NCT05782036
NCT05782036
Completed
Not Applicable

Development, Validation and Clinical Application of a Recovery Scale After Cardiac Surgery: the Fuwai-CRS (Fuwai- Cardiac Recovery Scale)

China National Center for Cardiovascular Diseases1 site in 1 country3,043 target enrollmentMay 16, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
China National Center for Cardiovascular Diseases
Enrollment
3043
Locations
1
Primary Endpoint
Death or unplanned readmission
Status
Completed
Last Updated
last year

Overview

Brief Summary

Improving patient recovery after cardiac surgery is a critical priority. While improved surgical techniques have substantially reduced procedural mortality over the past decades, the inherent physiological insult of median sternotomy, cardiopulmonary bypass, and myocardial manipulation continues to impose significant challenges in patient's recovery experience, such as pain, sleep disorders. Paradoxically, this critical recovery phase remains underexplored, as traditional outcome metrics predominantly focus on mortality and major morbidity endpoints. However, no cardiac surgery-specific tools currently exist to adequately capture postoperative recovery experience, creating barriers to optimal care. Accordingly, the investigators aim to develop and validate a recovery scale after cardiac surgery and evaluate its clinical performance compared to the generic scale (QoR-15)

Registry
clinicaltrials.gov
Start Date
May 16, 2023
End Date
December 31, 2024
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
China National Center for Cardiovascular Diseases
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Elective cardiac surgery

Exclusion Criteria

  • Emergency surgery
  • Age ≤ 18 years
  • Refuse to participate in this study
  • prolonged postoperative mechanical ventilation exceeding 24 hours reoperation or perioperative death

Outcomes

Primary Outcomes

Death or unplanned readmission

Time Frame: 3-month post operative

Secondary Outcomes

  • In-hospital mortality(From surgery to discharge, up to 7 days)
  • In-hospital stroke(From surgery to discharge, up to 7 days)
  • In-hospital myocardial infarction(From surgery to discharge, up to 7 days)
  • In-hospital acute renal failure(From surgery to discharge, up to 7 days)
  • In-hospital sternal wound infection(From surgery to discharge, up to 7 days)
  • In-hospital reoperation(From surgery to discharge, up to 7 days)
  • Length of hospital stay(Approximately 7 days)

Study Sites (1)

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