The Effect of Dexmedetomidine on Prevention of Postoperative Acute Kidney Injury in Patients Undergoing Aortic Surgery

NCT02607163 | Completed

• 1 other identifier: 4-2015-0672
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Kidney Injury(Postoperative Acute Kidney Injury in Patients Undergoing Aortic Surgery)

Outcome Measures

Primary Outcomes (1)

• Acute kidney injury (AKI) after aortic surgery (AKI according to the Kidney Disease Improving Global Outcomes (KDIGO) criteria)

  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

  up to 7 days after the aortic surgery

Secondary Outcomes (5)

• 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

• 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

• major morbidity endpoint

  acute kidney injury - up to 7 days after the surgery; Other - during the hospitalization for surgery

• postoperative delirium

  up to 7 days after the surgery

• drug-related adverse events

  hypotension or bradycardia: during surgery; Other - during surgery and 24 hours after surgery

Study Arms (2)

dexmedetomidine

EXPERIMENTAL

dexmedetomidine, 0.4 mcg/kg/h, IV, The infusion of study drug is started after anesthesia induction and continued until 24 hours after surgery.

Drug: dexmedetomidine

control

PLACEBO COMPARATOR

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.

Drug: saline

Interventions

dexmedetomidine DRUG

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.

dexmedetomidine

saline DRUG

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.

control

Eligibility Criteria

• Age: 20 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• the patients undergoing ascending, arch and/or proximal descending aorta surgery with cardiopulmonary bypass
• yrs old

You may not qualify if:

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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Department of Anesthesiology and Pain Medicine, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine

Seoul, 03722, South Korea

Location

Related Publications (1)

• 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.

  PMID: 32007239 DERIVED

MeSH Terms

Interventions

Dexmedetomidine; Sodium Chloride

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2015
• First Posted: November 17, 2015
• Study Start: September 1, 2015
• Primary Completion: March 6, 2019
• Study Completion: March 6, 2019
• Last Updated: September 9, 2019

Record last verified: 2019-09

Locations

KR (1)