Effect of Intraoperative Dexmedetomidine on Development of Acute Kidney Injury

Malignant Tumor Clinical Trial

Official title:

Effect of Intraoperative Dexmedetomidine on Development of Acute Kidney Injury Following Cytoreduction and Hyperthermic Intraperitoneal Chemotherapy: a Double-blind Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02641938
• Other study ID #: 3-2015-0262
• Status: Completed
• Phase: Phase 4
• First received: December 20, 2015
• Last updated: December 29, 2017
• Start date: December 2015
• Est. completion date: November 2017

Study information

• Verified date: December 2017
• Source: Gangnam Severance Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: November 2017
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Malignant Tumor
• Neoplasms

Intervention

Drug:
• Dexmedetomidine
Dexmedetomidine group :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
• Normal Saline
Control group :IV loading and infusion of same volume of normal saline after induction of anesthesia until the completion of the surgery

Locations

Country	Name	City	State
Korea, Republic of	GangnamSH	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Gangnam Severance Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of Creatinine clearance from baseline	Assessment of the creatinine clearance which reflects kidney function during postoperative 7 days	Postoperative day 1,2,3,4,5,6,7