Trial · NCT05635227
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 20
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Days alive and outside hospital | 90 days from surgery | |
| Secondary | Time to composite outcome of death and major organ damage | 90 days | Time in days to occurrence of any component in a composite secondary endpoint during follow-up consisting of 1. Death from any cause 2. Stroke, defined as persisting (\>24 hours) of any neurological symptoms of neurological dysfunction during the 6 months follow-up period. The diagnosis is determined by the treating physician. 3. Acute kidney injury requiring any type of renal replacement therapy during the follow-up period. 4. New onset or worsening heart failure, defined as persistent (\> 24 hours from initiation) need for vasopressor/inotropic hemodynamic support, need for mechanical circulatory support after surgery, inability to close the sternotomy due to hemodynamic instability after surgery or readmission for acute heart failure during follow-up. |
| Secondary | Number (fraction) of patients with severe post-operative complications during index admission, defined as a Clavien-Dindo class of 3 to 5. | During index admission up to 30 days after surgery. Outcome will be assessed upon hospital discharge. | The Clavien-Dindo classification runs from 1 to 5 with a higher score indicating more severe complications. |
| Secondary | Number (fraction) of patients with delirium, defined as a positive Confusion Assessment Method for the ICU (CAM-ICU) or wards (CAM). | During index admission up to 30 days after surgery. | Number (fraction) of patients with delirium during index admission will be reported. Outcome will be assessed daily until hospital discharge. |
| Secondary | Quality of Recovery-15 (QoR-15) score | 3 days or as soon as possible after surgery | The QoR-15 score includes 15 questions with each question being graded from 0-10. |
| Secondary | Survival | Within 90 days | |
| Secondary | Graft patency, assessed by cardiac computed tomography (CT) scan | After 90 days | |
| Secondary | Myocardial resting perfusion, assessed by cardiac CT scan | After 90 days | |
| Secondary | Change in modified Rankin Scale (mRS) from baseline | After 90 days | Score ranging from 0 to 6, with a higher score indicating a worse outcome. |
| Secondary | Health-related quality of life (EQ-5D-5L) | After 90 days | 5 dimensions and 5 questions with higher scores indicating a worse outcome. |
| Secondary | Change in self-perceived function "two simple questions" | After 90 days | Two questions: 'Have you within the past two weeks needed help for every day activities', and 'Do you feel that you have recovered completely after your operation' |
| Secondary | Days alive outside ICU within 90 days | 90 days | |
| Secondary | Survival | 180 days | |
| Other | Surgical wound infection | Within 90 days | Surgical wound infection including sternum infection and/or endocarditis, requiring antibiotics for \> 48 hours and/or surgical revision. |
| Other | Sepsis | Within 90 days | Sepsis, as defined by the Sepsis-3 criteria, requiring antibiotics for a minimum of 3 consecutive days. 3\) |
| Other | Acute kidney injury | Within 90 days | Acute kidney injury, as defined by the KDIGO criteria. |
| Other | Myocardial infarction | Within 90 days | Myocardial infarction, as defined by the Fourth Universal Definition of Myocardial Infarction. |
| Other | Bleeding | Within 90 days | Post-surgical bleeding requiring transfusion |
| Other | Readmission | Within 90 days | |
| Other | Re-operation for any cause | Within 90 days | This endpoint will be stratified by major causes. |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT05635227/registered