NCT01886079

Brief Summary

The purpose of study is to compare the incidence of acute kidney injury in patients receiving perioperative dexmedetomidine or placebo undergoing valvular heart surgery.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started May 2013

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 18, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 25, 2013

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

June 25, 2013

Status Verified

June 1, 2013

Enrollment Period

2 years

First QC Date

June 18, 2013

Last Update Submit

June 20, 2013

Conditions

Acute Kidney Injury

Outcome Measures

Primary Outcomes (1)

  • Comparison of postoperative renal function in patients with or without dexmedetomidine undergoing valvular heart surgery:

    BUN/Creatinine, cystatin C, eGFR, urine output Incidence of acute kidney injury (based on the AKIN criteria)

    24 hours after surgery.

Study Arms (2)

Dexmedetomidine group

EXPERIMENTAL
Drug: dexmedetomidine

Saline group

PLACEBO COMPARATOR
Drug: Saline

Interventions

dexmedetomidineDRUG

0.4 mcg/kg/h, IV, The infusion of study drug is started after anesthesia induction and continued until 24 hours after surgery

Dexmedetomidine group
SalineDRUG

0.4 mcg/kg/h, IV

Saline group

Eligibility Criteria

Age20 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adult patients over the age of 20 scheduled for valvular heart surgery

You may not qualify if:

  • Left ventricular-ejection fraction \< 30%
  • Preexisting congestive heart failure
  • Severe coronary artery disease
  • Hemodynamically unstable arrhythmia
  • Cardiogenic shock during perioperative period
  • Ventricular assist device
  • Severe renal dysfunction (eGFR \< 15ml/min per 1.73m2)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine

Seoul, 120-752, South Korea

RECRUITING

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

DexmedetomidineSodium Chloride

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Central Study Contacts

Jong Wook Song, MD

CONTACT

82-2-2228-2420SJW72331@yuhs.ac

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 18, 2013

First Posted

June 25, 2013

Study Start

May 1, 2013

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

June 25, 2013

Record last verified: 2013-06

Locations

KR(1)