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Clinical trial

Evaluation of Intraoperative Dexmedetomidine Use on Reducing Inflammatory Response Caused by Cardiopulmonary Bypass in Patients Undergoing Surgical Aortic Valve Replacement

ID
Name
78Z11053
Description
Aim of this randomized prospective study is to investigate the immunomodulatory effects of dexmedetomidine on outcomes in patients with isolated aortic stenosis after surgical aortic valve replacement.
Trial arms
Trial start
2022-11-22
Estimated PCD
2023-12-31
Trial end
2025-12-31
Status
Recruiting
Phase
Early phase I
Treatment
Placebo
Continuous infusion of saline starting after invasive monitoring placement before cardiopulmonary bypass (CPB) initiation up to surgery completion
Arms:
Saline
Other names:
saline
Dexmedetomidine 0.5mcg/kg/h
Continuous infusion of dexmedetomidine in 0.5mcg/kg/h dose starting after invasive monitoring placement before cardiopulmonary bypass (CPB) initiation up to surgery completion
Arms:
Dexmedetomidine 0.5
Other names:
dexmedetomidine in 0.5mcg/kg/h dose
Dexmedetomidine 1 mcg/kg/h
Continuous infusion of dexmedetomidine in 1mcg/kg/h dose starting after invasive monitoring placement before cardiopulmonary bypass (CPB) initiation up to surgery completion
Arms:
Dexmedetomidine 1
Other names:
dexmedetomidine in 1 mcg/kg/h dose
Size
60
Primary endpoint
interleukin 6
24 hours preoperatively up to 12 hours post CPB
tumor necrosis factor alpha
24 hours preoperatively up to 12 hours post CPB
Eligibility criteria
Inclusion Criteria: * isolated aortic stenosis adult patients with written consent Exclusion Criteria: * BMI \<30kg/m2 * 1st, 2nd and 3rd degree AV block * bradycardia HR\<50/min upon arrival to operating theatre * neurological disorders (Parkinson's disease, Myasthenia gravis, multiple sclerosis, brain tumors in anamnesis) * recent use of psychoactive drugs * alcohol and illicit drug addiction * diabetes type I with complications * patients who develop hypotension after initiation of dexmedetomidine infusion requiring vasoconstriction therapy * patients receiving corticosteroids in perioperative period * patients with known allergy to dexmedetomidine
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'maskingDescription': 'Randomization and study drug preparation by person(s) not involved in patient care, data gathering or outcome evaluation. Group allocation kept in sealed opaque envelope until all data gathered.', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 60, 'type': 'ESTIMATED'}}
Updated at
2023-05-11

1 organization

1 product

1 drug

2 indications

Organization
University Hospital Dubrava
Drug
Varlilumab
Indication
Systemic Inflammatory Response
Indication
Aortic Valve Stenosis
Product
Dexmedetomidine