DexmedetomidineNCT07841054
Renoprotective Effects of Dexmedetomidine Preconditioning in CABG Surgery
A study testing Dexmedetomidine and 0.9 % sodium chloride in people with Dexmedetomidine and Postoperative Acute Kidney Injury, run by Bursa City Hospital at 1 site in Turkey (Türkiye).
Trial summary
Acute kidney injury (AKI) is one of the most frequent complications of coronary artery bypass graft (CABG) surgery performed with cardiopulmonary bypass (CPB). Even small postoperative rises in serum creatinine are associated with longer intensive care stay and higher mortality. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Dexmedetomidine, Postoperative Acute Kidney Injury, Cardiopulmonary Bypass Graft
- What is being tested?
- Dexmedetomidine and 0.9 % sodium chloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Dec 2025to 1 Aug 2026
- Phase
- Interventional
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 80 years
- Scheduled for elective coronary artery bypass graft surgery with cardiopulmonary bypass at the study center
- American Society of Anesthesiologists (ASA) physical status class II or III
- Preoperative serum creatinine below 1.5 mg/dL
- Written informed consent obtained at the preoperative visit
Who cannot join
- Left main coronary artery stenosis greater than 50%
- Severe valvular dysfunction
- Severe left ventricular hypertrophy or cardiomyopathy
- Arrhythmia causing significant hemodynamic compromise
- Left ventricular ejection fraction below 35%
- Acute coronary syndrome or cardiovascular surgery within the preceding month
Show all 12Show fewer
- Estimated glomerular filtration rate below 15 mL/min/1.73 m2
- Nephropathy due to uncontrolled hypertension and/or diabetes mellitus
- Treatment of hypertension with a combination of an angiotensin-converting enzyme inhibitor, a diuretic and an alpha-2 adrenergic agonist
- Morbid obesity
- Hepatic dysfunction attributable to substance abuse or alcoholism
- Previous severe drug allergy during administration of dexmedetomidine
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Renoprotective Effects of Dexmedetomidine Pharmacological Preconditioning in Patients Undergoing Coronary Artery Bypass Grafting With Cardiopulmonary Bypass: A Randomized Controlled Trial
Acute kidney injury (AKI) is one of the most frequent complications of coronary artery bypass graft (CABG) surgery performed with cardiopulmonary bypass (CPB). Even small postoperative rises in serum creatinine are associated with longer intensive care stay and higher mortality. Ischemia-reperfusion injury, the systemic inflammatory response elicited by contact of blood with the bypass circuit, and heightened perioperative sympathetic activity are believed to contribute to its development.
Dexmedetomidine is a selective alpha-2 adrenergic receptor agonist used as a sedative and anesthetic adjunct. It attenuates sympathetic outflow and has shown anti-inflammatory and organ-protective properties in experimental models and in some cardiac surgical populations, but whether it reduces AKI after on-pump CABG surgery has not been established.
Read more
This is a prospective, randomized, double-blind, placebo-controlled, single-center trial in adults undergoing elective CABG surgery with CPB. One hundred patients aged 18-80 years, ASA physical status II or III, with a preoperative serum creatinine below 1.5 mg/dL are allocated 1:1 to a dexmedetomidine group (n=50) or a control group (n=50). Patients in the dexmedetomidine group receive a loading dose of 1 microgram/kg over 15 minutes after central venous catheterization, followed by a maintenance infusion of 0.5 microgram/kg/h until the start of CPB. Patients in the control group receive an equal volume of 0.9% sodium chloride over the same period and with the same infusion scheme. In both groups the infusion is stopped when CPB begins; no study drug is given during bypass or postoperatively. Anesthesia, surgery, CPB conduct, fluid and vasoactive therapy, and postoperative intensive care follow a standardized protocol with identical numerical thresholds in both groups, applied by clinicians unaware of group allocation.
The primary outcome is the incidence of postoperative AKI within the first 72 hours, staged according to the serum creatinine criteria of the KDIGO 2012 classification. Secondary outcomes are systemic inflammatory markers (white blood cell count, neutrophils, lymphocytes, neutrophil-to-lymphocyte ratio, C-reactive protein, procalcitonin), vasoactive drug requirement quantified by the vasoactive-inotropic score, need for renal replacement therapy, time to extubation, intensive care unit and hospital length of stay, and 30-day and 90-day mortality. All patients are followed until postoperative day 90.
All variables assessed in the study are parameters obtained as part of routine clinical care in this patient population; no additional intervention or additional laboratory test is performed for study purposes.
Read the detailed description
Acute kidney injury (AKI) is one of the most frequent complications of coronary artery bypass graft (CABG) surgery performed with cardiopulmonary bypass (CPB). Even small postoperative rises in serum creatinine are associated with longer intensive care stay and higher mortality. Ischemia-reperfusion injury, the systemic inflammatory response elicited by contact of blood with the bypass circuit, and heightened perioperative sympathetic activity are believed to contribute to its development.
Dexmedetomidine is a selective alpha-2 adrenergic receptor agonist used as a sedative and anesthetic adjunct. It attenuates sympathetic outflow and has shown anti-inflammatory and organ-protective properties in experimental models and in some cardiac surgical populations, but whether it reduces AKI after on-pump CABG surgery has not been established.
This is a prospective, randomized, double-blind, placebo-controlled, single-center trial in adults undergoing elective CABG surgery with CPB. One hundred patients aged 18-80 years, ASA physical status II or III, with a preoperative serum creatinine below 1.5 mg/dL are allocated 1:1 to a dexmedetomidine group (n=50) or a control group (n=50). Patients in the dexmedetomidine group receive a loading dose of 1 microgram/kg over 15 minutes after central venous catheterization, followed by a maintenance infusion of 0.5 microgram/kg/h until the start of CPB. Patients in the control group receive an equal volume of 0.9% sodium chloride over the same period and with the same infusion scheme. In both groups the infusion is stopped when CPB begins; no study drug is given during bypass or postoperatively. Anesthesia, surgery, CPB conduct, fluid and vasoactive therapy, and postoperative intensive care follow a standardized protocol with identical numerical thresholds in both groups, applied by clinicians unaware of group allocation.
The primary outcome is the incidence of postoperative AKI within the first 72 hours, staged according to the serum creatinine criteria of the KDIGO 2012 classification. Secondary outcomes are systemic inflammatory markers (white blood cell count, neutrophils, lymphocytes, neutrophil-to-lymphocyte ratio, C-reactive protein, procalcitonin), vasoactive drug requirement quantified by the vasoactive-inotropic score, need for renal replacement therapy, time to extubation, intensive care unit and hospital length of stay, and 30-day and 90-day mortality. All patients are followed until postoperative day 90.
All variables assessed in the study are parameters obtained as part of routine clinical care in this patient population; no additional intervention or additional laboratory test is performed for study purposes.
- Conditions
- Dexmedetomidine, Postoperative Acute Kidney Injury, Cardiopulmonary Bypass Graft, Postoperative Complications
- Being tested
- Dexmedetomidine, 0.9 % sodium chloride
- Keywords
- Cardiac surgery-associated acute kidney injury, Dexmedetomidine, Coronary artery bypass grafting, Cardiopulmonary bypass, Renal protection, Vasoactive-inotropic score
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Intravenous dexmedetomidine, started after central venous catheterization and a 5-minute period of hemodynamic stabilization: loading dose 1 microgram/kg over 15 minutes, followed by a maintenance infusion of 0.5 microgram/kg/h until the start of cardiopulmonary bypass. The infusion is prepared by a physician who is not involved in intraoperative or postoperative care, in a syringe indistinguishable from the placebo syringe.
0.9 % sodium chlorideDrug
Intravenous 0.9% sodium chloride in a volume equal to that of the study drug, administered over the same time intervals and with the same infusion scheme as dexmedetomidine (15-minute loading infusion followed by a maintenance infusion until the start of cardiopulmonary bypass).
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine | Experimental | Patients undergoing elective coronary artery bypass graft surgery with cardiopulmonary bypass (CPB) who receive intravenous dexmedetomidine in the pre-bypass period. After central venous catheterization and a subsequent 5-minute period of hemodynamic stabilization, a loading dose of 1 microgram/kg is infused over 15 minutes, followed by a maintenance infusion of 0.5 microgram/kg/h until the start of CPB. The infusion is terminated with the initiation of CPB; no study drug is given during bypass or postoperatively. All other aspects of anesthesia, surgery, CPB conduct, fluid and vasoactive therapy, and postoperative intensive care follow a standardized protocol identical to that used in the control arm. Receives: Drug: Dexmedetomidine |
| Control Group | Placebo comparator | Patients undergoing elective coronary artery bypass graft surgery with cardiopulmonary bypass (CPB) who receive an equal volume of 0.9% sodium chloride instead of dexmedetomidine. The placebo infusion is started after central venous catheterization and the subsequent 5-minute period of hemodynamic stabilization and is given over the same time intervals and with the same infusion scheme as in the dexmedetomidine arm (15-minute loading infusion followed by a maintenance infusion), and is terminated with the initiation of CPB. All other aspects of anesthesia, surgery, CPB conduct, fluid and vasoactive therapy, and postoperative intensive care follow the same standardized protocol as in the dexmedetomidine arm. Receives: Drug: 0.9 % sodium chloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of postoperative acute kidney injury (KDIGO serum creatinine criterion)
Number and percentage of participants developing acute kidney injury (AKI) of any stage (stage 1 or higher) according to the serum creatinine criterion of the KDIGO 2012 classification. The preoperative serum creatinine value is taken as the baseline; serum creatinine is measured at postoperative hours 0, 24, 48 and 72. AKI is defined as an increase in serum creatinine of 0.3 mg/dL or more from baseline within 48 hours, or a rise to 1.5 times baseline or higher, or the need for renal replacement therapy. The urine output criterion of the KDIGO classification is not applied.
Measured: From the preoperative baseline measurement to postoperative hour 72
Secondary outcomes (5)
Vasoactive-inotropic score
Intensity of vasoactive and inotropic support, calculated from the infusion rates being administered at each time point as: dopamine (mcg/kg/min) + dobutamine (mcg/kg/min) + 100 x epinephrine (mcg/kg/min) + 100 x norepinephrine(mcg/kg/min). Doses are converted to mcg/kg/min by dividing the infusion rate by the patient's body weight; the score is taken as zero in participants receiving no vasoactive drug, and higher scores indicate greater vasoactive support. The score is reported separately for each time point and, in addition, as two derived variables: maximum score (the highest of the T2, T3 and T4 values) and postoperative maximum score (the highest of the T3 and T4 values only, which excludes the transient support required during separation from cardiopulmonary bypass).
Measured: After separation from cardiopulmonary bypass, at intensive care unit admission (postoperative hour 0) and at postoperative hour 24
Systemic immune-inflammatory response
Systemic immune-inflammatory response assessed from the following laboratory parameters: total white blood cell count (10^3/microliter), absolute neutrophil count (10^3/microliter), absolute lymphocyte count (10^3/microliter), neutrophil-to-lymphocyte ratio (unitless, calculated as absolute neutrophil count divided by absolute lymphocyte count), C-reactive protein concentration (mg/L) and procalcitonin concentration (ng/mL). Each parameter is measured from venous blood samples obtained as part of routine clinical care and is reported separately; the preoperative value serves as the within-patient reference.
Measured: Preoperative baseline, at intensive care unit admission (postoperative hour 0) and at postoperative hour 24
Time to extubation
Duration of postoperative mechanical ventilation in hours, calculated from the ICU admission and extubation timestamps recorded in the hospital information management system.
Measured: From ICU admission to extubation, assessed up to postoperative day 7
Length of intensive care unit stay
Duration of ICU stay in hours, calculated from the admission and discharge timestamps recorded in the hospital information management system.
Measured: From ICU admission to ICU discharge, assessed up to postoperative day 30
Length of hospital stay
Duration of postoperative hospital stay in days, from the day of surgery to the day of hospital discharge.
Measured: From surgery to hospital discharge, assessed up to postoperative day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2026
- Study start20 Dec 2025
- Primary completion31 May 2026
- Study completion1 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DexmedetomidineStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bursa City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, eralp çevikkalp, Bursa City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07841054
- Sponsor's protocol ID
- Bursa City Hospital Thesis 2
- Other IDs
- 25-AKD-273
- Status last verified
- Sep 2026
- First submitted
- 18 Sep 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared
Publications
1. Kidney Disease: Improving Global Outcomes (KDIGO) Acute Kidney Injury Work Group. KDIGO Clinical Practice Guideline for Acute Kidney Injury. Kidney Int Suppl. 2012;2(1):1-138. 2. Nadim MK, Forni LG, Bihorac A, et al. Cardiac and vascular surgery-associated acute kidney injury: the 20th International Consensus Conference of the ADQI (Acute Disease Quality Initiative) Group. J Am Heart Assoc. 2018;7(11):e008834. 3. Walsh M, Devereaux PJ, Garg AX, et al. Relationship between intraoperative mean arterial pressure and clinical outcomes after noncardiac surgery: toward an empirical definition of hypotension. Anesthesiology. 2013;119(3):507-515. (PMID 23835589) 4. Li J, Wang R, Wan J, et al. Postoperative central venous pressure is associated with acute kidney injury in patients undergoing coronary artery bypass grafting. Front Cardiovasc Med. 2022;9:1016436. (PMID 36465466) 5. Gaies MG, Gurney JG, Yen AH, et al. Vasoactive-inotropic score as a predictor of morbidity and mortality in infants after cardiopulmonary bypass. Pediatr Crit Care Med. 2010;11(2):234-238. (PMID 19794327) 6. Cho JS, Shim JK, Soh S, Kim MK, Kwak YL. Perioperative dexmedetomidine reduces the incidence and severity of acute kidney injury following valvular heart surgery. Kidney Int. 2016;89(3):693-700. (PMID 26444030)
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Renoprotective Effects of Dexmedetomidine Pharmacological Preconditioning in Patients Undergoing Coronary Artery Bypass Grafting With Cardiopulmonary Bypass: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07841054
- Acronym / sponsor ID
- Bursa City Hospital Thesis 2
- Conditions
- Dexmedetomidine, Postoperative Acute Kidney Injury, Cardiopulmonary Bypass Graft, Postoperative Complications
- Keywords
- Cardiac surgery-associated acute kidney injury, Dexmedetomidine, Coronary artery bypass grafting, Cardiopulmonary bypass, Renal protection, Vasoactive-inotropic score
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Bursa City HospitalOther government
- Study start
- 20 Dec 2025 (actual)
- Primary completion
- 31 May 2026 (actual)
- Study completion
- 1 Aug 2026 (actual)
- First posted
- 25 Sep 2026 (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.
Acute kidney injury (AKI) is one of the most frequent complications of coronary artery bypass graft (CABG) surgery performed with cardiopulmonary bypass (CPB). Even small postoperative rises in serum creatinine are associated with longer intensive care stay and higher mortality. Ischemia-reperfusion injury, the systemic inflammatory response elicited by contact of blood with the bypass circuit, and heightened perioperative sympathetic activity are believed to contribute to its development.
Dexmedetomidine is a selective alpha-2 adrenergic receptor agonist used as a sedative and anesthetic adjunct. It attenuates sympathetic outflow and has shown anti-inflammatory and organ-protective properties in experimental models and in some cardiac surgical populations, but whether it reduces AKI after on-pump CABG surgery has not been established.
This is a prospective, randomized, double-blind, placebo-controlled, single-center trial in adults undergoing elective CABG surgery with CPB. One hundred patients aged 18-80 years, ASA physical status II or III, with a preoperative serum creatinine below 1.5 mg/dL are allocated 1:1 to a dexmedetomidine group (n=50) or a control group (n=50). Patients in the dexmedetomidine group receive a loading dose of 1 microgram/kg over 15 minutes after central venous catheterization, followed by a maintenance infusion of 0.5 microgram/kg/h until the start of CPB. Patients in the control group receive an equal volume of 0.9% sodium chloride over the same period and with the same infusion scheme. In both groups the infusion is stopped when CPB begins; no study drug is given during bypass or postoperatively. Anesthesia, surgery, CPB conduct, fluid and vasoactive therapy, and postoperative intensive care follow a standardized protocol with identical numerical thresholds in both groups, applied by clinicians unaware of group allocation.
The primary outcome is the incidence of postoperative AKI within the first 72 hours, staged according to the serum creatinine criteria of the KDIGO 2012 classification. Secondary outcomes are systemic inflammatory markers (white blood cell count, neutrophils, lymphocytes, neutrophil-to-lymphocyte ratio, C-reactive protein, procalcitonin), vasoactive drug requirement quantified by the vasoactive-inotropic score, need for renal replacement therapy, time to extubation, intensive care unit and hospital length of stay, and 30-day and 90-day mortality. All patients are followed until postoperative day 90.
All variables assessed in the study are parameters obtained as part of routine clinical care in this patient population; no additional intervention or additional laboratory test is performed for study purposes.
Detailed description
Acute kidney injury (AKI) is one of the most frequent complications of coronary artery bypass graft (CABG) surgery performed with cardiopulmonary bypass (CPB). Even small postoperative rises in serum creatinine are associated with longer intensive care stay and higher mortality. Ischemia-reperfusion injury, the systemic inflammatory response elicited by contact of blood with the bypass circuit, and heightened perioperative sympathetic activity are believed to contribute to its development.
Dexmedetomidine is a selective alpha-2 adrenergic receptor agonist used as a sedative and anesthetic adjunct. It attenuates sympathetic outflow and has shown anti-inflammatory and organ-protective properties in experimental models and in some cardiac surgical populations, but whether it reduces AKI after on-pump CABG surgery has not been established.
This is a prospective, randomized, double-blind, placebo-controlled, single-center trial in adults undergoing elective CABG surgery with CPB. One hundred patients aged 18-80 years, ASA physical status II or III, with a preoperative serum creatinine below 1.5 mg/dL are allocated 1:1 to a dexmedetomidine group (n=50) or a control group (n=50). Patients in the dexmedetomidine group receive a loading dose of 1 microgram/kg over 15 minutes after central venous catheterization, followed by a maintenance infusion of 0.5 microgram/kg/h until the start of CPB. Patients in the control group receive an equal volume of 0.9% sodium chloride over the same period and with the same infusion scheme. In both groups the infusion is stopped when CPB begins; no study drug is given during bypass or postoperatively. Anesthesia, surgery, CPB conduct, fluid and vasoactive therapy, and postoperative intensive care follow a standardized protocol with identical numerical thresholds in both groups, applied by clinicians unaware of group allocation.
The primary outcome is the incidence of postoperative AKI within the first 72 hours, staged according to the serum creatinine criteria of the KDIGO 2012 classification. Secondary outcomes are systemic inflammatory markers (white blood cell count, neutrophils, lymphocytes, neutrophil-to-lymphocyte ratio, C-reactive protein, procalcitonin), vasoactive drug requirement quantified by the vasoactive-inotropic score, need for renal replacement therapy, time to extubation, intensive care unit and hospital length of stay, and 30-day and 90-day mortality. All patients are followed until postoperative day 90.
All variables assessed in the study are parameters obtained as part of routine clinical care in this patient population; no additional intervention or additional laboratory test is performed for study purposes.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine | Experimental | Drug: DexmedetomidinePatients undergoing elective coronary artery bypass graft surgery with cardiopulmonary bypass (CPB) who receive intravenous dexmedetomidine in the pre-bypass period. After central venous catheterization and a subsequent 5-minute period of hemodynamic stabilization, a loading dose of 1 microgram/kg is infused over 15 minutes, followed by a maintenance infusion of 0.5 microgram/kg/h until the start of CPB. The infusion is terminated with the initiation of CPB; no study drug is given during bypass or postoperatively. All other aspects of anesthesia, surgery, CPB conduct, fluid and vasoactive therapy, and postoperative intensive care follow a standardized protocol identical to that used in the control arm. |
| Control Group | Placebo comparator | Drug: 0.9 % sodium chloridePatients undergoing elective coronary artery bypass graft surgery with cardiopulmonary bypass (CPB) who receive an equal volume of 0.9% sodium chloride instead of dexmedetomidine. The placebo infusion is started after central venous catheterization and the subsequent 5-minute period of hemodynamic stabilization and is given over the same time intervals and with the same infusion scheme as in the dexmedetomidine arm (15-minute loading infusion followed by a maintenance infusion), and is terminated with the initiation of CPB. All other aspects of anesthesia, surgery, CPB conduct, fluid and vasoactive therapy, and postoperative intensive care follow the same standardized protocol as in the dexmedetomidine arm. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 to 80 years
- Scheduled for elective coronary artery bypass graft surgery with cardiopulmonary bypass at the study center
- American Society of Anesthesiologists (ASA) physical status class II or III
- Preoperative serum creatinine below 1.5 mg/dL
- Written informed consent obtained at the preoperative visit
Key exclusion criteria (12 listed)
- Left main coronary artery stenosis greater than 50%
- Severe valvular dysfunction
- Severe left ventricular hypertrophy or cardiomyopathy
- Arrhythmia causing significant hemodynamic compromise
- Left ventricular ejection fraction below 35%
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 |
|---|---|---|
| DexmedetomidineIntravenous dexmedetomidine, started after central venous catheterization and a 5-minute period of hemodynamic stabilization: loading dose 1 microgram/kg over 15 minutes, followed by a maintenance infusion of 0.5 microgram/kg/h until the start of cardiopulmonary bypass. The infusion is prepared by a physician who is not involved in intraoperative or postoperative care, in a syringe indistinguishable from the placebo syringe. | Drug | Dexmedetomidine |
| 0.9 % sodium chlorideIntravenous 0.9% sodium chloride in a volume equal to that of the study drug, administered over the same time intervals and with the same infusion scheme as dexmedetomidine (15-minute loading infusion followed by a maintenance infusion until the start of cardiopulmonary bypass). | Drug | Control Group |
Primary outcome
Incidence of postoperative acute kidney injury (KDIGO serum creatinine criterion)
Time frame: From the preoperative baseline measurement to postoperative hour 72
Number and percentage of participants developing acute kidney injury (AKI) of any stage (stage 1 or higher) according to the serum creatinine criterion of the KDIGO 2012 classification. The preoperative serum creatinine value is taken as the baseline; serum creatinine is measured at postoperative hours 0, 24, 48 and 72. AKI is defined as an increase in serum creatinine of 0.3 mg/dL or more from baseline within 48 hours, or a rise to 1.5 times baseline or higher, or the need for renal replacement therapy. The urine output criterion of the KDIGO classification is not applied.
5 secondary outcomes
Vasoactive-inotropic score
Time frame: After separation from cardiopulmonary bypass, at intensive care unit admission (postoperative hour 0) and at postoperative hour 24
Systemic immune-inflammatory response
Time frame: Preoperative baseline, at intensive care unit admission (postoperative hour 0) and at postoperative hour 24
Time to extubation
Time frame: From ICU admission to extubation, assessed up to postoperative day 7
Length of intensive care unit stay
Time frame: From ICU admission to ICU discharge, assessed up to postoperative day 30
Length of hospital stay
Time frame: From surgery to hospital discharge, assessed up to postoperative day 30
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 25 Sep 2026.
- Background1. Kidney Disease: Improving Global Outcomes (KDIGO) Acute Kidney Injury Work Group. KDIGO Clinical Practice Guideline for Acute Kidney Injury. Kidney Int Suppl. 2012;2(1):1-138. 2. Nadim MK, Forni LG, Bihorac A, et al. Cardiac and vascular surgery-associated acute kidney injury: the 20th International Consensus Conference of the ADQI (Acute Disease Quality Initiative) Group. J Am Heart Assoc. 2018;7(11):e008834. 3. Walsh M, Devereaux PJ, Garg AX, et al. Relationship between intraoperative mean arterial pressure and clinical outcomes after noncardiac surgery: toward an empirical definition of hypotension. Anesthesiology. 2013;119(3):507-515. (PMID 23835589) 4. Li J, Wang R, Wan J, et al. Postoperative central venous pressure is associated with acute kidney injury in patients undergoing coronary artery bypass grafting. Front Cardiovasc Med. 2022;9:1016436. (PMID 36465466) 5. Gaies MG, Gurney JG, Yen AH, et al. Vasoactive-inotropic score as a predictor of morbidity and mortality in infants after cardiopulmonary bypass. Pediatr Crit Care Med. 2010;11(2):234-238. (PMID 19794327) 6. Cho JS, Shim JK, Soh S, Kim MK, Kwak YL. Perioperative dexmedetomidine reduces the incidence and severity of acute kidney injury following valvular heart surgery. Kidney Int. 2016;89(3):693-700. (PMID 26444030)
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexmedetomidine and 0.9 % sodium chloride in people with Dexmedetomidine and Postoperative Acute Kidney Injury, run by Bursa City Hospital at 1 site in Turkey (Türkiye).
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 5 inclusion and 12 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 25 Sep 2026. 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 Turkey (Türkiye). 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.
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?
Incidence of postoperative acute kidney injury (KDIGO serum creatinine criterion) (time frame: From the preoperative baseline measurement to postoperative hour 72). 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 NCT07841054, which also lists 1 linked publication.
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 25 Sep 2026.