Effects of Dexmedetomidine and Dopamine on Renal Function... | NCT03170739

Studies
Effects of Dexmedetomidine and Dopamine on Renal Function After Major Surgery

NCT03170739

Sponsor

Tao Zhang

Status

Unknown status

Last Update Posted

Jun 12, 2018Actual

Enrollment

180Estimated

Phase

Phase 4

Conditions

Renal Function

Interventions

Dexmedetomidine
Dopamine

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 6, 2017Actual

Primary Completion Date

Oct 2019Estimated

Completion Date

Dec 2019Estimated

First Submitted Date

May 17, 2017

First Submission Date that Met QC Criteria

May 26, 2017

First Posted Date

May 31, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 9, 2018

Last Update Posted Date

Jun 12, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Tao Zhang, Clinical Professor of Department of Anesthesiology, First Affiliated Hospital, Sun Yat-Sen UniversitySponsor-Investigator

Lead Sponsor

Tao ZhangOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

180Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Dexmedetomidine	Experimental	Dexmedetomidine 0.5ug/kg iv follow by 0.2ug/kg/h ivpump at the beginning of surgery.	Drug: Dexmedetomidine
Dopamine	Experimental	Dopamine 3ug/kg/min ivpump at the beginning of surgery.	Drug: Dopamine
Dexmedetomidine+dopamine	Experimental	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 Drug: Dopamine
Control group	No Intervention	No intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dexmedetomidine	Drug	Dexmedetomidine given during surgery.	Dexmedetomidine Dexmedetomidine+dopamine

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients undergoing selective major surgery

Exclusion Criteria:

Patients undergoing urologic surgery or neurosurgery
Patients with preoperative renal disorder

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
First Affiliated Hospital, Sun Yat-sen University	Recruiting	Guangzhou			China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24130886	Background	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.

ID	Term
D007093	Imidazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds