Effects of Dexmedetomidine and Dopamine on Renal Function After Major Surgery
1 other identifier
interventional
180
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jun 2017
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 17, 2017
CompletedFirst Posted
Study publicly available on registry
May 31, 2017
CompletedStudy Start
First participant enrolled
June 6, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedJune 12, 2018
June 1, 2018
2.3 years
May 17, 2017
June 9, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Postoperative renal function
Serum Cr and Cys-c
Change from baseline to the 5th day after surgery
Mortality
30 days
Postoperative complications
2 weeks
Study Arms (4)
Dexmedetomidine
EXPERIMENTALDexmedetomidine 0.5ug/kg iv follow by 0.2ug/kg/h ivpump at the beginning of surgery.
Dopamine
EXPERIMENTALDopamine 3ug/kg/min ivpump at the beginning of surgery.
Dexmedetomidine+dopamine
EXPERIMENTALDexmedetomidine 0.5ug/kg iv follow by 0.2ug/kg/h ivpump, combined with dopamine 3ug/kg/min ivpump at the beginning of surgery.
Control group
NO INTERVENTIONNo intervention
Interventions
Eligibility Criteria
You may qualify if:
- Patients undergoing selective major surgery
You may not qualify if:
- Patients undergoing urologic surgery or neurosurgery
- Patients with preoperative renal disorder
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tao Zhanglead
Study Sites (1)
First Affiliated Hospital, Sun Yat-sen University
Guangzhou, China
Related 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.
PMID: 24130886BACKGROUND
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Clinical Professor of Department of Anesthesiology
Study Record Dates
First Submitted
May 17, 2017
First Posted
May 31, 2017
Study Start
June 6, 2017
Primary Completion
October 1, 2019
Study Completion
December 1, 2019
Last Updated
June 12, 2018
Record last verified: 2018-06