Clinical trial NCT02607163: The Effect of Dexmedetomidine on Prevention of Postoperative Acute Kidney Injury in Patients Undergoing Aortic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Kidney Injury(Postoperative Acute Kidney Injury in Patients Undergoing Aortic Surgery)
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2015-11-17
Enrollment: 108
Sex: ALL
Minimum age (years): 20
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. the patients undergoing ascending, arch and/or proximal descending aorta surgery with cardiopulmonary bypass
2. 20 - 100 yrs old

Exclusion Criteria:

1. having preoperative severe renal dysfunction (eGFR \< 15 ml/min per 1.73m2)
2. Left ventricular-ejection fraction \< 30%
3. Preexisting congestive heart failure
4. Severe coronary artery disease
5. Hemodynamically unstable arrhythmia
6. Cardiogenic shock during perioperative period
7. Ventricular assist device use
8. cannot communication because of a language barrier or illiteracy

Primary outcomes:
measure: Acute kidney injury (AKI) after aortic surgery (AKI according to the Kidney Disease Improving Global Outcomes (KDIGO) criteria)
timeFrame: up to 7 days after the aortic surgery
Secondary outcomes:
measure: Acute kidney injury (AKI) after aortic surgery (AKI according to the Kidney Disease Improving Global Outcomes (KDIGO) criteria)
timeFrame: up to 7 days after the surgery
measure: Acute kidney injury (AKI) after aortic surgery (AKI according to the Kidney Disease Improving Global Outcomes (KDIGO) criteria)
timeFrame: up to 7 days after the surgery
measure: major morbidity endpoint
timeFrame: acute kidney injury - up to 7 days after the surgery; Other - during the hospitalization for surgery
measure: postoperative delirium
timeFrame: up to 7 days after the surgery
measure: drug-related adverse events
timeFrame: hypotension or bradycardia: during surgery; Other - during surgery and 24 hours after surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine
Study officials:
References:
citation: Soh S, Shim JK, Song JW, Bae JC, Kwak YL. Effect of dexmedetomidine on acute kidney injury after aortic surgery: a single-centre, placebo-controlled, randomised controlled trial. Br J Anaesth. 2020 Apr;124(4):386-394. doi: 10.1016/j.bja.2019.12.036. Epub 2020 Jan 29.