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

Primary Purpose

Infective Endocarditis

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
dexmedetomidine
Normal saline
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Infective Endocarditis focused on measuring Infective endocarditis, acute kidney injury, dexmedetomidine

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Anaesthesiology and Pain Medicine, Yonsei University College of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

dexmedetomidine group

Control group

Arm Description

Outcomes

Primary Outcome Measures

The incidence of acute kidney injury

Secondary Outcome Measures

Cystatin C level
serum cystatin C level (mg/L)
inflammatory mediator(IL-6) level
serum inflammatory mediator (IL-6(pg/mL)
inflammatory mediator(CRP) level
serum inflammatory mediator (CRP(mg/L))
inflammatory mediator(WBC) level
Serum WBC(/microL) level
inflammatory mediator(neutrophil count) level
serum inflammatory mediator (neutrophil count(/microL)) level
serum norepinephrine/epinephrine level(ng/mL)
intraoperative hemodynamics measured by amount of used vasopressors(mL)
intraoperative fluid intake and output
intraoperative intake and output measured by the amount of fluid(crystalloid/colloid)(mL) and blood administered(mL)
postoperative complications
postoperative complications such as development of myocardial infarction, arrhythmia, cerebrovascular accident, wound infection, and mortality.
Major adverse kidney events (MAKE)

Full Information

First Posted
February 15, 2016
Last Updated
January 14, 2019
Sponsor
Yonsei University
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1. Study Identification

Unique Protocol Identification Number
NCT02698930
Brief Title
Effect of Dexmedetomidine on Postoperative Renal Function in Infective Endocarditis Patients Undergoing Open Heart Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 2016 (Actual)
Primary Completion Date
October 2020 (Anticipated)
Study Completion Date
October 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infective Endocarditis
Keywords
Infective endocarditis, acute kidney injury, dexmedetomidine

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
94 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
dexmedetomidine group
Arm Type
Experimental
Arm Title
Control group
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
dexmedetomidine
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Normal saline
Intervention Description
Group given intravenous 0.4mcg/kg/h of normal saline from the beginning of the anesthesia to postoperative 1 day.
Primary Outcome Measure Information:
Title
The incidence of acute kidney injury
Time Frame
1 week
Secondary Outcome Measure Information:
Title
Cystatin C level
Description
serum cystatin C level (mg/L)
Time Frame
postoperative day 1,2,3 and 5
Title
inflammatory mediator(IL-6) level
Description
serum inflammatory mediator (IL-6(pg/mL)
Time Frame
postoperative day 1,2,3 and 5
Title
inflammatory mediator(CRP) level
Description
serum inflammatory mediator (CRP(mg/L))
Time Frame
postoperative day 1,2,3 and 5
Title
inflammatory mediator(WBC) level
Description
Serum WBC(/microL) level
Time Frame
postoperative day 1,2,3 and 5
Title
inflammatory mediator(neutrophil count) level
Description
serum inflammatory mediator (neutrophil count(/microL)) level
Time Frame
postoperative day 1,2,3 and 5
Title
serum norepinephrine/epinephrine level(ng/mL)
Time Frame
postoperative day 1,2,3 and 5
Title
intraoperative hemodynamics measured by amount of used vasopressors(mL)
Time Frame
postoperative day 1,2,3 and 5
Title
intraoperative fluid intake and output
Description
intraoperative intake and output measured by the amount of fluid(crystalloid/colloid)(mL) and blood administered(mL)
Time Frame
postoperative day 1,2,3 and 5
Title
postoperative complications
Description
postoperative complications such as development of myocardial infarction, arrhythmia, cerebrovascular accident, wound infection, and mortality.
Time Frame
postoperative day 1,2,3 and 5
Title
Major adverse kidney events (MAKE)
Time Frame
3month, 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Department of Anaesthesiology and Pain Medicine, Yonsei University College of Medicine
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jae-Kwang Shim, MD
Phone
82-2-2228-8500
Email
ANESHIM@yuhs.ac

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
18230632
Citation
Rosner MH, Portilla D, Okusa MD. Cardiac surgery as a cause of acute kidney injury: pathogenesis and potential therapies. J Intensive Care Med. 2008 Jan-Feb;23(1):3-18. doi: 10.1177/0885066607309998.
Results Reference
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PubMed Identifier
9524779
Citation
Conlon PJ, Jefferies F, Krigman HR, Corey GR, Sexton DJ, Abramson MA. Predictors of prognosis and risk of acute renal failure in bacterial endocarditis. Clin Nephrol. 1998 Feb;49(2):96-101.
Results Reference
background
PubMed Identifier
24137215
Citation
Ren J, Zhang H, Huang L, Liu Y, Liu F, Dong Z. Protective effect of dexmedetomidine in coronary artery bypass grafting surgery. Exp Ther Med. 2013 Aug;6(2):497-502. doi: 10.3892/etm.2013.1183. Epub 2013 Jun 25.
Results Reference
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Effect of Dexmedetomidine on Postoperative Renal Function in Infective Endocarditis Patients Undergoing Open Heart Surgery

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