Effect of Intraoperative Dexmedetomidine on Development of Acute Kidney Injury

Phase 4

Completed

• Conditions: Malignant Tumor
• Interventions: Drug: Normal Saline; Drug: Dexmedetomidine

• Registration Number: NCT02641938
• Lead Sponsor: Gangnam Severance Hospital

Brief Summary

To investigate the renal protective effect of dexmedetomidine in patients undergoing cytoreduction and hyperthermic intraperitoneal chemotherapy

Detailed Description

A cytoreductive surgery and hyperthermic intraperitoneal chemotherapy may lead to the renal hypoperfusion, systemic inflammatory response, and oxidative stress. Dexmedetomidine has been known to protect the kidney against inflammation and oxidative stress in diverse clinical settings. It may also enhance a renal perfusion by inhibition of renal sympathoexcitation. We hypothesized administration of dexmedetomidine might protect the kidney in patients undergoing cytoreduction and hyperthermic intraperitoneal chemotherapy.

Study Timeline

• Study Start: 2015-12
• Study First Submitted: 2015-12-20
• Study First Submitted QC: 2015-12-25
• Study First Posted: 2015-12-30
• Primary Completion: 2017-11
• Study Completion: 2017-11
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-29
• Last Update Posted: 2018-01-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

• Diagnosis of malignant tumor with peritoneal metastasis
• Scheduled for elective cytoreduction and hyperthermic intraperitoneal chemotherapy

Exclusion Criteria

• Preoperative chronic kidney disease stage ≥4 defined by KDOQI ( eGFR < 30 mL/min/1.73m2)
• Congestive heart failure
• Atrioventricular block > 1st degree
• Bradycardia < 45 beat per minute
• History of myocardial infarction within 3 months
• Pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Normal Saline	Normal Saline	IV loading and infusion of same volume of normal saline after induction of anesthesia until the completion of the surgery
Dexmedetomidine	Dexmedetomidine	1ug/kg IV loading over 20 minutes followed by 0.5ug/kg/hr IV infusion after induction of anesthesia until the completion of the surgery

Primary Outcome Measures

Name	Time	Method
Change of Creatinine clearance from baseline	Postoperative day 1,2,3,4,5,6,7	Assessment of the creatinine clearance which reflects kidney function during postoperative 7 days

Trial Locations

Locations (1)

GangnamSH; 🇰🇷 Seoul, Korea, Republic of