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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
Sponsor:
Information provided by (Responsible Party):
Yonsei University

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.


Condition or disease Intervention/treatment Phase
Acute Kidney Injury(Postoperative Acute Kidney Injury in Patients Undergoing Aortic Surgery) Drug: dexmedetomidine Drug: saline Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Actual Study Start Date : September 2015
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: dexmedetomidine
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
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.
Drug: 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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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



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Ages Eligible for Study:   20 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Contacts
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Contact: Sarah Soh, MD 82-2-2228-8512 yeonchoo@yuhs.ac

Locations
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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    yeonchoo@yuhs.ac   
Sponsors and Collaborators
Yonsei University

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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT02607163     History of Changes
Other Study ID Numbers: 4-2015-0672
First Posted: November 17, 2015    Key Record Dates
Last Update Posted: January 21, 2019
Last Verified: January 2019

Additional relevant MeSH terms:
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Wounds and Injuries
Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Anesthetics
Dexmedetomidine
Central Nervous System Depressants
Physiological Effects of Drugs
Hypnotics and Sedatives
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action