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Effect of Dexmedetomidine on Postoperative Renal Function in Infective Endocarditis Patients Undergoing Open Heart Surgery

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ClinicalTrials.gov Identifier: NCT02698930
Recruitment Status : Recruiting
First Posted : March 4, 2016
Last Update Posted : January 15, 2019
Sponsor:
Information provided by (Responsible Party):
Yonsei University

Brief Summary:

Acute kidney injury is major complication after open heart surgery. The cause of acute kidney injury following open heart surgery is related to activation of sympathetic nervous system, decrease of renal blood flow, ischemia-reperfusion injury and systemic inflammatory response.

Infective endocarditis patients undergoing open heart surgery have systemic inflammatory response associated with infective endocarditis. And the inflammatory response can be aggravated by cardiopulmonary bypass. The incidence of acute kidney injury following open heart surgery due to infective endocarditis was 50% in a previous report. And this acute kidney injury was related to the poor outcome and high mortality. Thus, the preventive method to protect kidney function will be needed in the patients with infective endocarditis undergoing open heart surgery.

Dexmedetomidine is a selective α2-agonist and has sedative, analgesic, and CNS depressive effect. And several experimental study demonstrated the renal protective effect. Intraoperative dexmedetomidine administration can reduce the amount of anesthetics needed and suppress the sympathetic response resulted by surgical stimulation. And dexmedetomidine was reported to reduce the level of serum cortisol, epinephrine and norepinephrine during the operation. Thus, these effects of dexmedetomidine can be expected to reduce the incidence of acute kidney injury.

Therefore, the investigators hypothesized that dexmedetomidine has renal protective effect and this effect might be related to the suppression of inflammatory response. Thus, the investigators will evaluate the incidence of acute kidney injury and the incidence of major adverse kidney events (MAKE) after open heart surgery due to infective endocarditis and the level of inflammatory mediators.

The primary end point of this study is the incidence of acute kidney injury after open heart surgery due to infective endocarditis. And secondary end point is the incidence of MAKE, the level of cystatin C which is related to the renal function, the level of inflammatory mediator and the postoperative morbidities.


Condition or disease Intervention/treatment Phase
Infective Endocarditis Drug: dexmedetomidine Drug: Normal saline Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 94 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Actual Study Start Date : August 2016
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endocarditis

Arm Intervention/treatment
Experimental: dexmedetomidine group Drug: dexmedetomidine
Randomly selected patients of the dexmedetomidine group are given intravenous 0.4mcg/kg/h of dexmedetomidine from the beginning of the anesthesia to postoperative 1 day.

Placebo Comparator: Control group Drug: Normal saline
Group given intravenous 0.4mcg/kg/h of normal saline from the beginning of the anesthesia to postoperative 1 day.




Primary Outcome Measures :
  1. The incidence of acute kidney injury [ Time Frame: 1 week ]

Secondary Outcome Measures :
  1. Cystatin C level [ Time Frame: postoperative day 1,2,3 and 5 ]
    serum cystatin C level (mg/L)

  2. inflammatory mediator(IL-6) level [ Time Frame: postoperative day 1,2,3 and 5 ]
    serum inflammatory mediator (IL-6(pg/mL)

  3. inflammatory mediator(CRP) level [ Time Frame: postoperative day 1,2,3 and 5 ]
    serum inflammatory mediator (CRP(mg/L))

  4. inflammatory mediator(WBC) level [ Time Frame: postoperative day 1,2,3 and 5 ]
    Serum WBC(/microL) level

  5. inflammatory mediator(neutrophil count) level [ Time Frame: postoperative day 1,2,3 and 5 ]
    serum inflammatory mediator (neutrophil count(/microL)) level

  6. serum norepinephrine/epinephrine level(ng/mL) [ Time Frame: postoperative day 1,2,3 and 5 ]
  7. intraoperative hemodynamics measured by amount of used vasopressors(mL) [ Time Frame: postoperative day 1,2,3 and 5 ]
  8. intraoperative fluid intake and output [ Time Frame: postoperative day 1,2,3 and 5 ]
    intraoperative intake and output measured by the amount of fluid(crystalloid/colloid)(mL) and blood administered(mL)

  9. postoperative complications [ Time Frame: postoperative day 1,2,3 and 5 ]
    postoperative complications such as development of myocardial infarction, arrhythmia, cerebrovascular accident, wound infection, and mortality.

  10. Major adverse kidney events (MAKE) [ Time Frame: 3month, 1 year ]


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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients with infective endocarditis
  • patients who are scheduled to undergo open heart surgery

Exclusion Criteria:

  • chronic kidney disease
  • taking high dose steroid (>10mg/day prednisolone or equivalent)
  • age under 20 years
  • cognitive dysfunction
  • disabling mental change disorder
  • unable to communicate or speak Korean

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): NCT02698930


Locations
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Korea, Republic of
Department of Anaesthesiology and Pain Medicine, Yonsei University College of Medicine Recruiting
Seoul, Korea, Republic of, 120-752
Contact: Jae-Kwang Shim, MD    82-2-2228-8500    ANESHIM@yuhs.ac   
Sponsors and Collaborators
Yonsei University

Publications:
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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT02698930     History of Changes
Other Study ID Numbers: 4-2015-0839
First Posted: March 4, 2016    Key Record Dates
Last Update Posted: January 15, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Yonsei University:
Infective endocarditis
acute kidney injury
dexmedetomidine
Additional relevant MeSH terms:
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Endocarditis, Bacterial
Endocarditis
Heart Diseases
Cardiovascular Diseases
Bacterial Infections
Cardiovascular Infections
Infection
Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
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