Effects of Dexmedetomidine and Dopamine on Renal Function After Major Surgery

Renal Function Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03170739
• Other study ID #: DexR
• Status: Recruiting
• Phase: Phase 4
• Start date: June 6, 2017
• Est. completion date: December 2019

Study information

• Verified date: June 2018
• Source: First Affiliated Hospital, Sun Yat-Sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: December 2019
• Est. primary completion date: October 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients undergoing selective major surgery

Exclusion Criteria:

• Patients undergoing urologic surgery or neurosurgery

• Patients with preoperative renal disorder

Related Conditions & MeSH terms

• Renal Function

Intervention

Drug:
• Dexmedetomidine
Dexmedetomidine given during surgery.
• Dopamine
Dopamine given during surgery.

Locations

Country	Name	City	State
China	First Affiliated Hospital, Sun Yat-sen University	Guangzhou

Sponsors (1)

Lead Sponsor	Collaborator
Tao Zhang

Country where clinical trial is conducted

China, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative renal function	Serum Cr and Cys-c	Change from baseline to the 5th day after surgery
Primary	Mortality		30 days
Primary	Postoperative complications		2 weeks