Effects of Dexmedetomidine and Dopamine on Renal Function After Major Surgery

• Sponsor: Tao Zhang (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03170739
• Collaborator: (none)
• Enrollment: 180
• Location: 1
• Arms: 4
• Anticipated Duration (Months): 29.8
• Patients Per Site Per Month: 6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Renal Function	Drug: Dexmedetomidine; Drug: Dopamine	Phase 4

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 180 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Effects of Dexmedetomidine and Dopamine on Renal Function After Selective Major Surgery in Adult Patients
• Actual Study Start Date: Jun 6, 2017
• Anticipated Primary Completion Date: Oct 1, 2019
• Anticipated Study Completion Date: Dec 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dexmedetomidine Dexmedetomidine 0.5ug/kg iv follow by 0.2ug/kg/h ivpump at the beginning of surgery.	Drug: Dexmedetomidine; Dexmedetomidine given during surgery.
Experimental: Dopamine Dopamine 3ug/kg/min ivpump at the beginning of surgery.	Drug: Dopamine; Dopamine given during surgery.
Experimental: Dexmedetomidine+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.	Drug: Dexmedetomidine; Dexmedetomidine given during surgery.; Drug: Dopamine; Dopamine given during surgery.
No Intervention: Control group No intervention

Outcome Measures

Primary Outcome Measures

1. Postoperative renal function [Change from baseline to the 5th day after surgery]

   Serum Cr and Cys-c

2. Mortality [30 days]

3. Postoperative complications [2 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients undergoing selective major surgery

Exclusion Criteria:

• Patients undergoing urologic surgery or neurosurgery

• Patients with preoperative renal disorder

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	First Affiliated Hospital, Sun Yat-sen University	Guangzhou		China

Sponsors and Collaborators

• Tao Zhang

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• Ji F, Li Z, Young JN, Yeranossian A, Liu H. Post-bypass dexmedetomidine use and postoperative acute kidney injury in patients undergoing cardiac surgery with cardiopulmonary bypass. PLoS One. 2013 Oct 10;8(10):e77446. doi: 10.1371/journal.pone.0077446. eCollection 2013.

• Responsible Party: Tao Zhang, Clinical Professor of Department of Anesthesiology, First Affiliated Hospital, Sun Yat-Sen University
• ClinicalTrials.gov Identifier: NCT03170739
• Other Study ID Numbers: DexR
• First Posted: May 31, 2017
• Last Update Posted: Jun 12, 2018
• Last Verified: Jun 1, 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Tao Zhang, Clinical Professor of Department of Anesthesiology, First Affiliated Hospital, Sun Yat-Sen University: dexmedetomidine; dopamine; surgery
• Additional relevant MeSH terms: Dopamine; Dexmedetomidine

Study Results

No Results Posted as of Jun 12, 2018