Aortic Valve Stenosis, Systemic Inflammatory Response
Conditions
Keywords
dexmedetomidine
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.
Detailed description
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.
Interventions
DRUGPlacebo
Continuous infusion of saline starting after invasive monitoring placement before cardiopulmonary bypass (CPB) initiation up to surgery completion
DRUGDexmedetomidine 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
DRUGDexmedetomidine 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
Sponsors
University Hospital Dubrava
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| interleukin 6 | 24 hours preoperatively up to 12 hours post CPB | Concentration of IL-6 24 hours preoperatively (T0), before CPB initiation (T1), 5 hours post CPB (T2) and 12 hours post CPB (T3) |
| tumor necrosis factor alpha | 24 hours preoperatively up to 12 hours post CPB | Concentration of TNF-alpha 24 hours preoperatively (T0), before CPB initiation (T1), 5 hours post CPB (T2) and 12 hours post CPB (T3) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Renal function - diuresis | From recruitment date up to 10 days postoperatively | Determining parameters of renal function: Daily 24-hour urine output in ml |
| Renal function - diuretic consumption | From recruitment date up to 10 days postoperatively | Determining parameters of renal function: diuretic consumption |
| Renal function - GFR | From recruitment date up to 10 days postoperatively | Determining parameters of renal function: glomerular filtration rate |
| Inflammatory marker concentration during hospital stay | From recruitment date up to 30 days postoperatively | Determination of concentration of CRP and procalcitonin during hospital stay |
| Renal function - urea | From recruitment date up to 10 days postoperatively | Determining parameters of renal function: urea concentration |
| Postoperative delirium | From recruitment date up to 30 days postoperatively | Determining incidence of postoperative delirium using Confusion Assessment Method questionaire |
| Analgesic and anesthetic consumption | From recruitment date up to 10 days postoperatively | Determining intraoperative anesthetic consumption (midazolam, sufentanil, propofol and sevoflurane) and postoperative analgesic use |
| Renal function - creatinine | From recruitment date up to 10 days postoperatively | Determining parameters of renal function: creatinine concentration |
| Infection rate | From recruitment date up to 30 days postoperatively | Determining incidence of wound infection, pneumonia, urinary infection and sepsis during hospital stay |
Countries
Croatia
Outcome results
None listed