The Effect of Dexmedetomidine on Prevention of Postoperative Acute Kidney Injury in Patients Undergoing Aortic Surgery
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|ClinicalTrials.gov Identifier: NCT02607163|
Recruitment Status : Recruiting
First Posted : November 17, 2015
Last Update Posted : January 21, 2019
Acute kidney injury(AKI) is a common and severe complication after the cardiac surgery. Postoperative AKI increases the in-hospital stay, intensive care unit(ICU) stay and postoperative mortality. Aortic surgery is the most risky surgery that causes the postoperative AKI, and the incidence of AKI after aortic surgery is about 50%.
The α1- and α2-adrenergic receptors in the kidney modulate vasoconstrictor and vasodilatory effects, respectively. Agents that attenuate renal vasoconstriction may have potential as renoprotective drugs because vasoconstriction most likely contributes to the pathophysiology of AKI. Clonidine, an α2-agonist, has been shown experimentally to inhibit renin release and cause a diuresis, and it has been evaluated in an experimental AKI model, confirming its potential as a renoprotective agent. Furthermore, it has been already reported that dexmedetomidine, α2-agonist, reduce the impairment of renal function after cardiac operation.
The aim of this study is to examine the association between preoperative dexmedetomidine infusion and the incidence of postoperative acute kidney injury(AKI) in patients undergoing aortic surgery.
|Condition or disease||Intervention/treatment||Phase|
|Acute Kidney Injury(Postoperative Acute Kidney Injury in Patients Undergoing Aortic Surgery)||Drug: dexmedetomidine Drug: saline||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||108 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Actual Study Start Date :||September 2015|
|Estimated Primary Completion Date :||May 2019|
|Estimated Study Completion Date :||May 2019|
dexmedetomidine, 0.4 mcg/kg/h, IV, The infusion of study drug is started after anesthesia induction and continued until 24 hours after surgery.
Immediately after the induction of anesthesia, patients in the dexmedetomidine group received dexmedetomidine continuous intravenous (IV) infusion of 0.4 mcg/kg/h until 24 hours after surgery.
Placebo Comparator: control
saline, same infusion rate (received equal volume of normal saline), IV, The infusion of study drug is started after anesthesia induction and continued until 24 hours after surgery.
same infusion rate (received equal volume of normal saline), IV, The infusion of study drug is started after anesthesia induction and continued until 24 hours after surgery.
- Postoperative acute kidney injury (AKI) after aortic surgery [AKI according to the Acute Kidney Injury Network classifications (AKIN stage 1, 2 and 3)] [ Time Frame: up to 48 hours after the aortic surgery ]Serum creatinine increase ≥ 0.3 mg/dl OR increase to 1.5-fold from baseline OR urine output < 0.5 ml/kg/h for 6h
- Postoperative acute kidney injury (AKI) after aortic surgery [AKI according to the Acute Kidney Injury Network classifications (AKIN stage 2 and 3)] [ Time Frame: up to 5 days after the aortic surgery ]AKIN stage 2: Serum creatinine increase to 2-3-fold from baseline OR urine output < 0.5 ml/kg/h for 12h AKIN stage 3: Serum creatinine increase to 3.0-fold from baseline OR serum creatinine ≥ 4 mg/dl with an acute increase of at least 0.5 mg/dl OR urine output < 0.3 ml/kg/h for 24h OR anuria 12h OR need of RRT
- major adverse kidney events assessed 90 days after posteoprative acute kidney injury [ Time Frame: 90 days after posteoprative acute kidney injury ]major adverse kidney events: death, initiation of dialysis, or 25% decrease in eGFR
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02607163
|Contact: Sarah Soh, MDemail@example.com|
|Korea, Republic of|
|Department of Anesthesiology and Pain Medicine, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine||Recruiting|
|Seoul, Korea, Republic of, 03722|
|Contact: Sarah Soh, MD 82-2-2228-8512 firstname.lastname@example.org|