Trial · NCT05635227
Dexamethasone, Olanzapine, Hemodynamics, and Ventilation in Cardiac Surgery
NCT05635227, Not applicable, Recruiting, Copenhagen University Hospital, Rigshospitalet
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Dexamethasone, Olanzapine, Hemodynamics, and Ventilation in Cardiac Surgery. Trials, record NCT05635227. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05635227
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Dexamethasone, Olanzapine, Hemodynamics, and Ventilation in Cardiac Surgery
- NCT number
- NCT05635227
- Status
- Recruiting
- Phases
- Not applicable
- Enrollment
- 1,200 participants, estimated
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Conditions
- Coronary Artery Disease, Aortic Valve Disease
- Interventions
Dexamethasone phosphate, Isotonic sodium chloride (0.9%), Olanzapine 10 MG, Placebo capsule, Flow-targeted hemodynamic management, Pressure-targeted hemodynamic management, Low tidal-volume ventilation, No ventilation
- First posted
- 2022-12-02
- Last updated
- 2025-04-04
Source ClinicalTrials.gov
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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. |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
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 trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05635227
GET https://conductscience.org/api/trials/v1/NCT05635227/registered