Acute Kidney Injury(Postoperative Acute Kidney Injury in Patients Undergoing Aortic Surgery)
Conditions
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.
Interventions
DRUGdexmedetomidine
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.
DRUGsaline
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.
Sponsors
Yonsei University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acute kidney injury (AKI) after aortic surgery (AKI according to the Kidney Disease Improving Global Outcomes (KDIGO) criteria) | up to 7 days after the aortic surgery | 0.3 mg/dl increase in serum creatinine concentration within 48 hours OR, a 50% increase within 7 days postoperatively OR, urine volume \< 0.5 ml/kg/h for 6 hours |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acute kidney injury (AKI) after aortic surgery (AKI according to the Kidney Disease Improving Global Outcomes (KDIGO) criteria) | up to 7 days after the surgery | KDIGO stage 2: Serum creatinine increase to 2-3-fold from baseline OR urine output \< 0.5 ml/kg/h for 12h |
| major morbidity endpoint | acute kidney injury - up to 7 days after the surgery; Other - during the hospitalization for surgery | acute kidney injury (same as the primary endpoint), permanent stroke, prolonged ventilator care \>24h, deep wound infection, and mortality. |
| postoperative delirium | up to 7 days after the surgery | delirium - assessed with The American Psychiatric Association's fifth edition of the Diagnostic and Statistical Manual of Mental Disorders or Confusion Assessment Method for the ICU |
| drug-related adverse events | hypotension or bradycardia: during surgery; Other - during surgery and 24 hours after surgery | hypotension (mean arterial pressure \<60 mmHg) or bradycardia (\<50 beats/min) OR the use of vasopressor, inotropes or temporary pacing, OR postoperative arrhythmia |
Countries
South Korea
Outcome results
None listed