NCT01920542

Brief Summary

we hypothized dexmedetomidine could reduce the reduction of renal function after cardiopulmonary bypass weaning in pediatric patients

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

August 8, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 12, 2013

Completed
20 days until next milestone

Study Start

First participant enrolled

September 1, 2013

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

November 10, 2016

Status Verified

November 1, 2016

Enrollment Period

2.8 years

First QC Date

August 8, 2013

Last Update Submit

November 8, 2016

Conditions

Acute Renal Injury

Outcome Measures

Primary Outcomes (1)

  • renal function

    at immediate after anesthetic induction (baseline), after weaning of cardiopulmonary bypass, 2h after end of operationCPB, sodium and creatinine in the urine and serum, N-acetyl-b-glucosaminidase (NAG)and albumin in only urine could be studied

    from anesthetic induction up to postoperative 2h

Study Arms (2)

no dexmedetomidine

EXPERIMENTAL

no administration of dexmedetomidine

Drug: no dexmedetomidine

dexmedetomidine

ACTIVE COMPARATOR

administration of 0.5ug/kg dexmedetomidine for 10 min and infusion of 0.5ug/kg/h of dexmedetomidine until weaning of cardiopulmonary bypass

Drug: Dexmedetomidine

Interventions

DexmedetomidineDRUG

administration of dexmedetomidine on dexemedetomidine group

Also known as: administration of dexmedetomidine
dexmedetomidine
no dexmedetomidineDRUG

no administration of dexmedetomidine on control group

Also known as: no administration of dexmedetomidine
no dexmedetomidine

Eligibility Criteria

Age1 Year - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • yr pediatric cardiac patients

You may not qualify if:

  • previous renal dysfunction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gachon University Gil Medical Cneter

Incheon, South Korea

Location

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Kyung Cheon Lee, M.D., Ph.D

    Gachon University Gil Medical Center

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

August 8, 2013

First Posted

August 12, 2013

Study Start

September 1, 2013

Primary Completion

July 1, 2016

Study Completion

August 1, 2016

Last Updated

November 10, 2016

Record last verified: 2016-11

Locations

KR(1)