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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Saline | Placebo Comparator | Continuous infusion of saline starting after invasive monitoring placement and before initiation of cardiopulmonary bypass (CPB) until the end of surgery |
|
| Dexmedetomidine 0.5 | Experimental | 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 |
|
| Dexmedetomidine 1 | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Continuous infusion of saline starting after invasive monitoring placement before cardiopulmonary bypass (CPB) initiation up to surgery completion |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Inflammatory marker concentration during hospital stay | Determination of concentration of CRP and procalcitonin during hospital stay | From recruitment date up to 30 days postoperatively |
| Infection rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zrinka Safaric Oremus, MD | UH Dubrava | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University hospital Dubrava | Zagreb | 10000 | Croatia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29290897 | Background | 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. | |
| 26909786 | Background | Bulow 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. |
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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.
|
| Dexmedetomidine 0.5mcg/kg/h | Drug | Continuous infusion of dexmedetomidine in 0.5mcg/kg/h dose starting after invasive monitoring placement before cardiopulmonary bypass (CPB) initiation up to surgery completion |
|
|
| Dexmedetomidine 1 mcg/kg/h | Drug | Continuous infusion of dexmedetomidine in 1mcg/kg/h dose starting after invasive monitoring placement before cardiopulmonary bypass (CPB) initiation up to surgery completion |
|
|
Determining incidence of wound infection, pneumonia, urinary infection and sepsis during hospital stay
| From recruitment date up to 30 days postoperatively |
| Renal function - diuresis | Determining parameters of renal function: Daily 24-hour urine output in ml | From recruitment date up to 10 days postoperatively |
| Renal function - diuretic consumption | Determining parameters of renal function: diuretic consumption | From recruitment date up to 10 days postoperatively |
| Renal function - GFR | Determining parameters of renal function: glomerular filtration rate | From recruitment date up to 10 days postoperatively |
| Renal function - creatinine | Determining parameters of renal function: creatinine concentration | From recruitment date up to 10 days postoperatively |
| Renal function - urea | Determining parameters of renal function: urea concentration | From recruitment date up to 10 days postoperatively |
| Postoperative delirium | Determining incidence of postoperative delirium using Confusion Assessment Method questionaire | 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 | From recruitment date up to 10 days postoperatively |
| 30409131 | Background | Lee 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. |
| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014694 | Ventricular Outflow Obstruction |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| D020927 | Dexmedetomidine |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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