Effects of Dexmedetomidine and Dopamine on Renal Function After Major Surgery

Phase 4

• Conditions: Renal Function
• Interventions: Drug: Dexmedetomidine; Drug: Dopamine

• Registration Number: NCT03170739
• Lead Sponsor: Tao Zhang

Brief Summary

Acute kidney injury (AKI) is associated with complications that may lead to multiorgan dysfunction and potentially to multi-organ failure after major surgery. Dexmedetomidine is a highly selective alpha(2)-adreno receptor agonist widely used during anesthesia. In animals, dexmedetomidine has shown protective effects in AKI after surgery. Dopamine (DA) is an organic chemical of the catecholamine and phenethylamine families that has been widely used to increased renal blood flow and urine output during surgery. However, the clinical effects of dexmedetomidine and dopamine on renal function are still controversial. The aim of this study is to investigate whether dexmedetomidine and dopamine have positive effects on renal function after selective major surgery.

Detailed Description

Acute kidney injury (AKI) is associated with complications that may lead to multiorgan dysfunction and potentially to multi-organ failure in critically ill patients. AKI accounts for 5-10% after general surgery to 45% after cardiac surgery during hospital stays and tends to be associated with increased length of hospital stay as well as increased morbidity and mortality. Even slight increases in postoperative serum creatinine concentrations have been associated with almost 5-fold increases in mortality. Dexmedetomidine is a potent and highly selective alpha(2)-adreno receptor agonist that has analgesic, sedative, anxiolytic, and sympatholytic effects. In animals, dexmedetomidine has shown protective effects in several models of ischemia-reperfusion, which is thought to be the principal mechanism of AKI in the context of surgery. Dopamine (DA) is an organic chemical of the catecholamine and phenethylamine families that has been widely used to increased renal blood flow and urine output. However, the clinical effects of dexmedetomidine and dopamine on renal function are still controversial. The aim of this study is to investigate whether dexmedetomidine and dopamine have positive effects on renal function after selective major surgery.

Study Timeline

• Study First Submitted: 2017-05-17
• Study First Submitted QC: 2017-05-26
• Study First Posted: 2017-05-31
• Study Start: 2017-06-06
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-09
• Last Update Posted: 2018-06-12
• Primary Completion: 2019-10
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

• Patients undergoing selective major surgery

Exclusion Criteria

• Patients undergoing urologic surgery or neurosurgery
• Patients with preoperative renal disorder

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dexmedetomidine	Dexmedetomidine	Dexmedetomidine 0.5ug/kg iv follow by 0.2ug/kg/h ivpump at the beginning of surgery.
Dopamine	Dopamine	Dopamine 3ug/kg/min ivpump at the beginning of surgery.
Dexmedetomidine+dopamine	Dexmedetomidine	Dexmedetomidine 0.5ug/kg iv follow by 0.2ug/kg/h ivpump, combined with dopamine 3ug/kg/min ivpump at the beginning of surgery.
Dexmedetomidine+dopamine	Dopamine	Dexmedetomidine 0.5ug/kg iv follow by 0.2ug/kg/h ivpump, combined with dopamine 3ug/kg/min ivpump at the beginning of surgery.

Primary Outcome Measures

Name	Time	Method
Mortality	30 days
Postoperative complications	2 weeks
Postoperative renal function	Change from baseline to the 5th day after surgery	Serum Cr and Cys-c

Trial Locations

Locations (1)

First Affiliated Hospital, Sun Yat-sen University; 🇨🇳 Guangzhou, China