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

Infective Endocarditis Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02698930
• Other study ID #: 4-2015-0839
• Status: Recruiting
• Phase: N/A
• Start date: August 2016
• Est. completion date: October 2020

Study information

• Verified date: January 2019
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 94
• Est. completion date: October 2020
• Est. primary completion date: October 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Endocarditis
• Endocarditis, Bacterial
• Infective Endocarditis

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Department of Anaesthesiology and Pain Medicine, Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (3)

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. — View 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. Epub 2013 Jun 25. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of acute kidney injury		1 week
Secondary	Cystatin C level	serum cystatin C level (mg/L)	postoperative day 1,2,3 and 5
Secondary	inflammatory mediator(IL-6) level	serum inflammatory mediator (IL-6(pg/mL)	postoperative day 1,2,3 and 5
Secondary	inflammatory mediator(CRP) level	serum inflammatory mediator (CRP(mg/L))	postoperative day 1,2,3 and 5
Secondary	inflammatory mediator(WBC) level	Serum WBC(/microL) level	postoperative day 1,2,3 and 5
Secondary	inflammatory mediator(neutrophil count) level	serum inflammatory mediator (neutrophil count(/microL)) level	postoperative day 1,2,3 and 5
Secondary	serum norepinephrine/epinephrine level(ng/mL)		postoperative day 1,2,3 and 5
Secondary	intraoperative hemodynamics measured by amount of used vasopressors(mL)		postoperative day 1,2,3 and 5
Secondary	intraoperative fluid intake and output	intraoperative intake and output measured by the amount of fluid(crystalloid/colloid)(mL) and blood administered(mL)	postoperative day 1,2,3 and 5
Secondary	postoperative complications	postoperative complications such as development of myocardial infarction, arrhythmia, cerebrovascular accident, wound infection, and mortality.	postoperative day 1,2,3 and 5
Secondary	Major adverse kidney events (MAKE)		3month, 1 year