Systemic Inflammatory ResponsePhase 3NCT05641064
Evaluation of Intraoperative Dexmedetomidine Use in Patients Undergoing Surgical Aortic Valve Replacement
A Phase 3 study testing Dexmedetomidine 0.5mcg/kg/h and Dexmedetomidine 1 mcg/kg/h in people with Systemic Inflammatory Response and Aortic Valve Stenosis, run by University Hospital Dubrava at 1 site in Croatia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Systemic Inflammatory Response, Aortic Valve Stenosis
- What is being tested?
- Dexmedetomidine 0.5mcg/kg/h and Dexmedetomidine 1 mcg/kg/h
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteCroatia
- Study dates
- 22 Nov 2022to 22 Sep 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- isolated aortic stenosis adult patients with written consent
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Intraoperative Dexmedetomidine Use on Reducing Inflammatory Response Caused by Cardiopulmonary Bypass in Patients Undergoing Surgical Aortic Valve Replacement
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.
Read the 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.
- Being tested
- Placebo, Dexmedetomidine 0.5mcg/kg/h, Dexmedetomidine 1 mcg/kg/h
- Keywords
- dexmedetomidine
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Also called saline
Continuous infusion of saline starting after invasive monitoring placement before cardiopulmonary bypass (CPB) initiation up to surgery completion
Dexmedetomidine 0.5mcg/kg/hDrug
Also called dexmedetomidine in 0.5mcg/kg/h dose
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/hDrug
Also called dexmedetomidine in 1 mcg/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
| Study group | Role | What they receive |
|---|---|---|
| Saline | Placebo comparator | Continuous infusion of saline starting after invasive monitoring placement and before initiation of cardiopulmonary bypass (CPB) until the end of surgery Receives: Drug: Placebo |
| 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 Receives: Drug: Dexmedetomidine 0.5mcg/kg/h |
| 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 Receives: Drug: Dexmedetomidine 1 mcg/kg/h |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 24 hours preoperatively up to 12 hours post CPB
Secondary outcomes (9)
Inflammatory marker concentration during hospital stay
Determination of concentration of CRP and procalcitonin during hospital stay
Measured: From recruitment date up to 30 days postoperatively
Infection rate
Determining incidence of wound infection, pneumonia, urinary infection and sepsis during hospital stay
Measured: From recruitment date up to 30 days postoperatively
Renal function - diuresis
Determining parameters of renal function: Daily 24-hour urine output in ml
Measured: From recruitment date up to 10 days postoperatively
Renal function - diuretic consumption
Determining parameters of renal function: diuretic consumption
Measured: From recruitment date up to 10 days postoperatively
Renal function - GFR
Determining parameters of renal function: glomerular filtration rate
Measured: From recruitment date up to 10 days postoperatively
Renal function - creatinine
Determining parameters of renal function: creatinine concentration
Measured: From recruitment date up to 10 days postoperatively
Renal function - urea
Determining parameters of renal function: urea concentration
Measured: From recruitment date up to 10 days postoperatively
Postoperative delirium
Determining incidence of postoperative delirium using Confusion Assessment Method questionaire
Measured: 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
Measured: From recruitment date up to 10 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2022
- Study start22 Nov 2022
- Primary completion22 Sep 2024
- Study completion22 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Systemic Inflammatory ResponseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Dubrava
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zrinka Safaric Oremus, University Hospital Dubrava
- Investigators
- Zrinka Safaric Oremus, MD, Principal investigator, UH Dubrava
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05641064
- Sponsor's protocol ID
- 78Z11053
- Status last verified
- Mar 2025
- First submitted
- 2 Nov 2022
- Last updated
- 30 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29290897Bulow 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.
PubMed 26909786Lee 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.
PubMed 30409131
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Intraoperative Dexmedetomidine Use on Reducing Inflammatory Response Caused by Cardiopulmonary Bypass in Patients Undergoing Surgical Aortic Valve Replacement
- ClinicalTrials.gov ID
- NCT05641064
- Acronym / sponsor ID
- 78Z11053
- Keywords
- dexmedetomidine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Hospital DubravaUniversity, hospital or other
- Study start
- 22 Nov 2022 (actual)
- Primary completion
- 22 Sep 2024 (actual)
- Study completion
- 22 Sep 2024 (actual)
- First posted
- 7 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Saline | Placebo comparator | Drug: PlaceboContinuous infusion of saline starting after invasive monitoring placement and before initiation of cardiopulmonary bypass (CPB) until the end of surgery |
| Dexmedetomidine 0.5 | Experimental | Drug: Dexmedetomidine 0.5mcg/kg/hContinuous 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 | Drug: Dexmedetomidine 1 mcg/kg/hContinuous 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 |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- isolated aortic stenosis adult patients with written consent
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboAlso: salineContinuous infusion of saline starting after invasive monitoring placement before cardiopulmonary bypass (CPB) initiation up to surgery completion | Drug | Saline |
| Dexmedetomidine 0.5mcg/kg/hAlso: dexmedetomidine in 0.5mcg/kg/h doseContinuous infusion of dexmedetomidine in 0.5mcg/kg/h dose starting after invasive monitoring placement before cardiopulmonary bypass (CPB) initiation up to surgery completion | Drug | Dexmedetomidine 0.5 |
| Dexmedetomidine 1 mcg/kg/hAlso: dexmedetomidine in 1 mcg/kg/h doseContinuous infusion of dexmedetomidine in 1mcg/kg/h dose starting after invasive monitoring placement before cardiopulmonary bypass (CPB) initiation up to surgery completion | Drug | Dexmedetomidine 1 |
Primary outcome
interleukin 6
Time frame: 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
Time frame: 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)
9 secondary outcomes
Inflammatory marker concentration during hospital stay
Time frame: From recruitment date up to 30 days postoperatively
Infection rate
Time frame: From recruitment date up to 30 days postoperatively
Renal function - diuresis
Time frame: From recruitment date up to 10 days postoperatively
Renal function - diuretic consumption
Time frame: From recruitment date up to 10 days postoperatively
Renal function - GFR
Time frame: From recruitment date up to 10 days postoperatively
Renal function - creatinine
Time frame: From recruitment date up to 10 days postoperatively
Renal function - urea
Time frame: From recruitment date up to 10 days postoperatively
Postoperative delirium
Time frame: From recruitment date up to 30 days postoperatively
Analgesic and anesthetic consumption
Time frame: From recruitment date up to 10 days postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2025.
- Background: PubMed 29290897Ma 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.
- Background: PubMed 26909786Bulow 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.
- Background: PubMed 30409131Lee 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zrinka Safaric Oremus, MD principal investigator
UH Dubrava
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dexmedetomidine 0.5mcg/kg/h and Dexmedetomidine 1 mcg/kg/h in people with Systemic Inflammatory Response and Aortic Valve Stenosis, run by University Hospital Dubrava at 1 site in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
interleukin 6 (time frame: 24 hours preoperatively up to 12 hours post CPB). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05641064, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2025.