Dexamethasone, olanzapine, hemodynamics, and ventilation in cardiac surgery

Phase 1

• 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).; MedDRA version: 20.0Level: HLTClassification code 10011085Term: Ischaemic coronary artery disordersSystem Organ Class: 10007541 - Cardiac disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]; MedDRA version: 20.0Level: LLTClassification code 10008937Term: Chronic ischemic heart disease, unspecifiedSystem Organ Class: 10007541 - Cardiac disorders; MedDRA version: 21.1Level: PTClassification code 10061994Term: Heart valve operationSystem Organ Class: 10042613 - Surgical and medical procedures

• Registration Number: EUCTR2021-005618-32-DK
• Lead Sponsor: Rigshospitalet

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-11-18
• Last Update Posted: 19 December 2023

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 1200

Inclusion Criteria

1)Adult, i.e., above 18 years of age
2)Scheduled for CABG and/or AVR, irrespective of other concomitant valve surgery.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 400
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 800

Exclusion Criteria

1)Acute surgery (i.e. off hours surgery)
2)Pregnancy or currently breastfeeding
3)Known endocarditis at time of screening
4)Previous participation in the trial
5)Active infection, including bacterial, viral, and/or fungal infection
6)Known hepatic cirrhosis
7)Known severe thrombocytopenia with thrombocyte levels < 50 x 109/L
8)Known severe neutropenia with neutrocyte levels < 2 x 109/L
9)On the waiting list for a heart transplant
10)Recipient of any major organ transplant
11)Obstructive hypertrophic cardiomyopathy, active myocarditis, constrictive pericarditis, untreated hypothyroidism or hyperthyroidism
12)Having received cytotoxic/cytostatic chemotherapy or radiation therapy for treatment of malignancy within the last 6 months.
13)Clinical evidence of current malignancy except for basal or localized squamous cell carcinoma, cervical intraepithelial neoplasia or stable prostate cancer.
14)Known narrow-angle glaucoma
15)Known phenylketonuria
16)Type I diabetes
17)Known long QT syndrome
18)Known allergy for any of the included study drugs
19)Any condition, where participation in the study, in the investigator’s opinion could put the subject at risk, confound the study results or interfere significantly with participation in the study

Specific exclusion criteria
Patients with extracardiac arteriopathy (assessed as part of the pre-operative EuroSCORE) will be excluded from the intervention ‘flow-targeted vs. pressure-targeted hemodynamic management during CPB’.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified