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

NCT02698930 | Unknown

• 1 other identifier: 4-2015-0839
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

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.

Conditions

Infective Endocarditis

Keywords

Infective endocarditis; acute kidney injury; dexmedetomidine

Outcome Measures

Primary Outcomes (1)

• The incidence of acute kidney injury

  1 week

Secondary Outcomes (10)

• Cystatin C level

  postoperative day 1,2,3 and 5

• inflammatory mediator(IL-6) level

  postoperative day 1,2,3 and 5

• inflammatory mediator(CRP) level

  postoperative day 1,2,3 and 5

• inflammatory mediator(WBC) level

  postoperative day 1,2,3 and 5

• inflammatory mediator(neutrophil count) level

  postoperative day 1,2,3 and 5

Study Arms (2)

dexmedetomidine group

EXPERIMENTAL

Drug: dexmedetomidine

Control group

PLACEBO COMPARATOR

Drug: Normal saline

Interventions

dexmedetomidine DRUG

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.

dexmedetomidine group

Normal saline DRUG

Group given intravenous 0.4mcg/kg/h of normal saline from the beginning of the anesthesia to postoperative 1 day.

Control group

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

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

Seoul, 120-752, South Korea

RECRUITING

Related Publications (3)

• 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.

  PMID: 18230632 BACKGROUND

• 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.

  PMID: 9524779 BACKGROUND

• 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.

  PMID: 24137215 BACKGROUND

MeSH Terms

Conditions

Endocarditis; Acute Kidney Injury

Interventions

Dexmedetomidine; Saline Solution

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2016
• First Posted: March 4, 2016
• Study Start: August 1, 2016
• Primary Completion: October 1, 2020
• Study Completion: October 1, 2020
• Last Updated: January 15, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)