Effects of Dexmedetomidine and Dopamine on Renal Function After Major Surgery

Study Overview
=================
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.

Official Title
-----------------
Effects of Dexmedetomidine and Dopamine on Renal Function After Selective Major Surgery in Adult Patients

Conditions
-----------------
Renal Function

Intervention / Treatment
-----------------
* Drug: Dexmedetomidine
* Drug: Dopamine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing selective major surgery Exclusion Criteria: Patients undergoing urologic surgery or neurosurgery Patients with preoperative renal disorder

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dexmedetomidine<br>Dexmedetomidine 0.5ug/kg iv follow by 0.2ug/kg/h ivpump at the beginning of surgery. | Drug: Dexmedetomidine<br>* Dexmedetomidine given during surgery.<br>|
| Experimental: Dopamine<br>Dopamine 3ug/kg/min ivpump at the beginning of surgery. | Drug: Dopamine<br>* Dopamine given during surgery.<br>|
| Experimental: Dexmedetomidine+dopamine<br>Dexmedetomidine 0.5ug/kg iv follow by 0.2ug/kg/h ivpump, combined with dopamine 3ug/kg/min ivpump at the beginning of surgery. | Drug: Dexmedetomidine<br>* Dexmedetomidine given during surgery.<br>Drug: Dopamine<br>* Dopamine given during surgery.<br>|
| No Intervention: Control group<br>No intervention | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative renal function | Serum Cr and Cys-c | Change from baseline to the 5th day after surgery | 
| Mortality |  | 30 days | 
| Postoperative complications |  | 2 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
dexmedetomidine, dopamine, surgery