We investigate the efficacy of two pharmaceutical interventions for reducing mortality and organ damage, and shortening length of hospital stay in patients undergoing heart surgery (i.e. coronary artery bypass grafting and/or heart valve replacement).
Conditions
Brief summary
The primary endpoint will be number of days alive and outside hospital within 90 days after surgery.
Detailed description
Time in days to occurrence of any component in a composite secondary endpoint during follow-up: a) Death from any cause, b) Stroke, c) Acute kidney injury or d) New onset or worsening heart failure, Severe post-operative complications during index admission, defined as a Clavien-Dindo class of 3 to 5., Delirium during the first 7 days after surgery, defined as a positive Confusion Assessment Method for the ICU (CAM-ICU) score or a positive Confusion Assessment Method (CAM) score for the general wards, Quality of Recovery-15 (QoR-15) score 3 days, or as soon as possible, after surgery, 90-day outcomes: Survival, Change in modified Rankin Scale (mRS) from baseline, Health-related quality of life (EQ-5D-5L), Change in self-perceived function "two simple questions" and Days alive outside ICU, 180-day outcomes: Survival
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint will be number of days alive and outside hospital within 90 days after surgery. | — |
Secondary
| Measure | Time frame |
|---|---|
| Time in days to occurrence of any component in a composite secondary endpoint during follow-up: a) Death from any cause, b) Stroke, c) Acute kidney injury or d) New onset or worsening heart failure, Severe post-operative complications during index admission, defined as a Clavien-Dindo class of 3 to 5., Delirium during the first 7 days after surgery, defined as a positive Confusion Assessment Method for the ICU (CAM-ICU) score or a positive Confusion Assessment Method (CAM) score for the general wards, Quality of Recovery-15 (QoR-15) score 3 days, or as soon as possible, after surgery, 90-day outcomes: Survival, Change in modified Rankin Scale (mRS) from baseline, Health-related quality of life (EQ-5D-5L), Change in self-perceived function "two simple questions" and Days alive outside ICU, 180-day outcomes: Survival | — |
Countries
Denmark