A Phase 3 interventional study of Placebo and Dexmedetomidine 0.5mcg/kg/h in Systemic Inflammatory Response and Aortic Valve Stenosis, sponsored by University Hospital Dubrava. Completed at 1 site in Croatia. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2025-03-30.
Sponsored by University Hospital Dubrava · Phase 3, Interventional, and Treatment
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.
Study will investigate effects of two different doses of dexmedetomidine on concentrations of tumor necrosis factor-α and interleukin-6, on inflammatory parameters (C reactive protein and procalcitonin) and inflammatory complications, renal function, postoperative delirium, anaesthetic and analgetic consumption and compare it to control group. It should provide a better understanding of dexmedetomidine effect on decrease of inflammatory response in patients undergoing cardiac surgery. Short-term infusion of dexmedetomidine could reduce inflammatory postoperative complications, contribute to improvement of perioperative renal function and occurrence of postoperative delirium, supporting recovery and shortening hospital stay.
985 studies on the registry are indexed under Aortic Valve Stenosis; 282 are open to participants now.
This study's enrollment of 60 is below the median of 120 across 525 interventional studies indexed under Aortic Valve Stenosis.
Browse Aortic Valve Stenosis studies →University Hospital Dubrava is the lead sponsor of 39 studies on the registry; 11 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Continuous infusion of saline starting after invasive monitoring placement and before initiation of cardiopulmonary bypass (CPB) until the end of surgery
Drug: Placebo
Continuous 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
Drug: Dexmedetomidine 0.5mcg/kg/h
Continuous 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
Drug: Dexmedetomidine 1 mcg/kg/h
Continuous infusion of saline starting after invasive monitoring placement before cardiopulmonary bypass (CPB) initiation up to surgery completion
Also known as: saline
Continuous infusion of dexmedetomidine in 0.5mcg/kg/h dose starting after invasive monitoring placement before cardiopulmonary bypass (CPB) initiation up to surgery completion
Also known as: dexmedetomidine in 0.5mcg/kg/h dose
Continuous infusion of dexmedetomidine in 1mcg/kg/h dose starting after invasive monitoring placement before cardiopulmonary bypass (CPB) initiation up to surgery completion
Also known as: dexmedetomidine in 1 mcg/kg/h dose
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)
Time frame: 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)
Time frame: 24 hours preoperatively up to 12 hours post CPB
Inflammatory marker concentration during hospital stay
Determination of concentration of CRP and procalcitonin during hospital stay
Time frame: From recruitment date up to 30 days postoperatively
Infection rate
Determining incidence of wound infection, pneumonia, urinary infection and sepsis during hospital stay
Time frame: From recruitment date up to 30 days postoperatively
Renal function - diuresis
Determining parameters of renal function: Daily 24-hour urine output in ml
Time frame: From recruitment date up to 10 days postoperatively
Renal function - diuretic consumption
Determining parameters of renal function: diuretic consumption
Time frame: From recruitment date up to 10 days postoperatively
Renal function - GFR
Determining parameters of renal function: glomerular filtration rate
Time frame: From recruitment date up to 10 days postoperatively
Renal function - creatinine
Determining parameters of renal function: creatinine concentration
Time frame: From recruitment date up to 10 days postoperatively
Renal function - urea
Determining parameters of renal function: urea concentration
Time frame: From recruitment date up to 10 days postoperatively
Postoperative delirium
Determining incidence of postoperative delirium using Confusion Assessment Method questionaire
Time frame: From recruitment date up to 30 days postoperatively
Analgesic and anesthetic consumption
Determining intraoperative anesthetic consumption (midazolam, sufentanil, propofol and sevoflurane) and postoperative analgesic use
Time frame: From recruitment date up to 10 days postoperatively
Plan to share: No
This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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University Hospital Dubrava