Effects of Dexmedetomidine and Dopamine on Renal Function After Major Surgery

NCT03170739 — Phase 4, Unknown, 180 participants, Tao Zhang

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

RegistryNCT03170739
StatusUnknown
PhasePhase 4
Study typeInterventional; randomized, parallel, masking: double, prevention
Enrollment180 (Estimated)
SponsorTao Zhang (Other)
ConditionsRenal Function
InterventionsDexmedetomidine, Dopamine (Drug)
Datesstart 2017-06-06, primary completion 2019-10-01 (estimated), completion 2019-12-01 (estimated), first posted 2017-05-31, last updated 2018-06-12
Locations1 site in China

Related Papers Related Patents Related Grants Related Experts
All trials for Renal Function All trials of Dexmedetomidine All trials of Dopamine

-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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
DexmedetomidineExperimentalDrug: DexmedetomidineDexmedetomidine 0.5ug/kg iv follow by 0.2ug/kg/h ivpump at the beginning of surgery.
DopamineExperimentalDrug: DopamineDopamine 3ug/kg/min ivpump at the beginning of surgery.
Dexmedetomidine+dopamineExperimentalDrug: Dexmedetomidine; Drug: DopamineDexmedetomidine 0.5ug/kg iv follow by 0.2ug/kg/h ivpump, combined with dopamine 3ug/kg/min ivpump at the beginning of surgery.
Control groupNo interventionNo intervention
  • Dexmedetomidine (Drug): Dexmedetomidine given during surgery.
  • Dopamine (Drug): Dopamine given during surgery.

+Outcome measures

Primary outcomes

  • Postoperative renal function [Change from baseline to the 5th day after surgery]: Serum Cr and Cys-c
  • Mortality [30 days]
  • Postoperative complications [2 weeks]

+Eligibility

Sex: All, ages: 18 Years to 80 Years

Inclusion Criteria:

* Patients undergoing selective major surgery

Exclusion Criteria:

* Patients undergoing urologic surgery or neurosurgery
* Patients with preoperative renal disorder

+Locations (1)

FacilityCityCountryStatus
First Affiliated Hospital, Sun Yat-sen UniversityGuangzhouChinaRecruiting

+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. PMID 24130886