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GLORIOUS II: Dexamethasone, olanzapine, flow-targeted versus pressure-targeted hemodynamic management, and low tidal volume ventilation in patients undergoing on-pump cardiac surgery – a multifactorial design randomized trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-515998-94-00
Acronym
2021-HJEPharma-002
Enrollment
1200
Registered
2024-10-23
Start date
2022-11-10
Completion date
Unknown
Last updated
2024-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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).

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

DRUGOlanzapine Glenmark Europe 20 mg orodispersible tablets
DRUGPLACEBO
DRUGopløsning

Sponsors

Rigshospitalet
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
The primary endpoint will be number of days alive and outside hospital within 90 days after surgery.

Secondary

MeasureTime 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

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026