Evaluation of Intraoperative Dexmedetomidine Use in Patients Undergoing Surgical Aortic Valve Replacement
1 other identifier
interventional
60
1 country
1
Brief Summary
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Nov 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 2022
CompletedStudy Start
First participant enrolled
November 22, 2022
CompletedFirst Posted
Study publicly available on registry
December 7, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 22, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
September 22, 2024
CompletedMarch 30, 2025
March 1, 2025
1.8 years
November 2, 2022
March 25, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
interleukin 6
Concentration of IL-6 24 hours preoperatively (T0), before CPB initiation (T1), 5 hours post CPB (T2) and 12 hours post CPB (T3)
24 hours preoperatively up to 12 hours post CPB
tumor necrosis factor alpha
Concentration of TNF-alpha 24 hours preoperatively (T0), before CPB initiation (T1), 5 hours post CPB (T2) and 12 hours post CPB (T3)
24 hours preoperatively up to 12 hours post CPB
Secondary Outcomes (9)
Inflammatory marker concentration during hospital stay
From recruitment date up to 30 days postoperatively
Infection rate
From recruitment date up to 30 days postoperatively
Renal function - diuresis
From recruitment date up to 10 days postoperatively
Renal function - diuretic consumption
From recruitment date up to 10 days postoperatively
Renal function - GFR
From recruitment date up to 10 days postoperatively
- +4 more secondary outcomes
Study Arms (3)
Saline
PLACEBO COMPARATORContinuous infusion of saline starting after invasive monitoring placement and before initiation of cardiopulmonary bypass (CPB) until the end of surgery
Dexmedetomidine 0.5
EXPERIMENTALContinuous infusion of dexmedetomidine in dose 0.5 mcg/kg/min starting after invasive monitoring placement and before initiation of cardiopulmonary bypass (CPB) until the end of surgery
Dexmedetomidine 1
EXPERIMENTALContinuous infusion of dexmedetomidine in dose 1 mcg/kg/min starting after invasive monitoring placement and before initiation of cardiopulmonary bypass (CPB) until the end of surgery
Interventions
Continuous infusion of saline starting after invasive monitoring placement before cardiopulmonary bypass (CPB) initiation up to surgery completion
Continuous infusion of dexmedetomidine in 0.5mcg/kg/h dose starting after invasive monitoring placement before cardiopulmonary bypass (CPB) initiation up to surgery completion
Continuous infusion of dexmedetomidine in 1mcg/kg/h dose starting after invasive monitoring placement before cardiopulmonary bypass (CPB) initiation up to surgery completion
Eligibility Criteria
You may qualify if:
- isolated aortic stenosis adult patients with written consent
You may not qualify if:
- BMI \<30kg/m2
- st, 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University hospital Dubrava
Zagreb, 10000, Croatia
Related Publications (3)
Ma Y, Yu XY, Wang Y. Dose-related effects of dexmedetomidine on immunomodulation and mortality to septic shock in rats. World J Emerg Med. 2018;9(1):56-63. doi: 10.5847/wjem.j.1920-8642.2018.01.009.
PMID: 29290897BACKGROUNDBulow NM, Colpo E, Pereira RP, Correa EF, Waczuk EP, Duarte MF, Rocha JB. Dexmedetomidine decreases the inflammatory response to myocardial surgery under mini-cardiopulmonary bypass. Braz J Med Biol Res. 2016;49(4):e4646. doi: 10.1590/1414-431X20154646. Epub 2016 Feb 23.
PMID: 26909786BACKGROUNDLee JM, Han HJ, Choi WK, Yoo S, Baek S, Lee J. Immunomodulatory effects of intraoperative dexmedetomidine on T helper 1, T helper 2, T helper 17 and regulatory T cells cytokine levels and their balance: a prospective, randomised, double-blind, dose-response clinical study. BMC Anesthesiol. 2018 Nov 8;18(1):164. doi: 10.1186/s12871-018-0625-2.
PMID: 30409131BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zrinka Safaric Oremus, MD
UH Dubrava
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Masking Details
- 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.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
November 2, 2022
First Posted
December 7, 2022
Study Start
November 22, 2022
Primary Completion
September 22, 2024
Study Completion
September 22, 2024
Last Updated
March 30, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will not share