NCT00480740

Brief Summary

The purpose of this study is to examine the pharmacokinetics, pharmacodynamics, and pharmacogenomics of dexmedetomidine in the following three pediatric patient populations: patients with bi-directional cavopulmonary anastomosis or a Fontan procedure, patients who have had a cardiac transplant, and patients with otherwise normal physiology who are undergoing closure of a patent ductus arteriosis or atrial septal defect.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
41

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Dec 2006

Longer than P75 for phase_3

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2006

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 29, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 31, 2007

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
3.7 years until next milestone

Results Posted

Study results publicly available

June 26, 2015

Completed
Last Updated

June 26, 2015

Status Verified

June 1, 2015

Enrollment Period

4.8 years

First QC Date

May 29, 2007

Results QC Date

August 19, 2014

Last Update Submit

June 17, 2015

Conditions

Cardiac TransplantPatent Ductus ArteriousAtrial Septal DefectBidirectional Cavopulmonary Anastomosis

Keywords

DexmedetomidineCongenital heart diseasepharmacokineticspharmacodynamicspediatricBidirectional cavopulmonary anastomosisFontan physiologyCardiac transplant

Outcome Measures

Primary Outcomes (1)

  • Changes in Hemodynamic Variables Recorded During Administration of Sevoflurane + Dexmedetomidine.

    Non-inferiority was shown when differences at steady-state (dexmedetomidine + sevoflurane) compared to baseline (sevoflurane alone) and its associated 95% confidence interval fell completely within the range of plus or minus 20%.The 95% confidence interval was normalized by subtracting the baseline values. Bispectral Index: monitors electroencephalographic and electromyographic parameters to monitor the depth of anesthesia.

    Up to 24 hours following cardiac catheterization

Study Arms (3)

Cardiac Transplant

EXPERIMENTAL

diagnostic cardiac catheterization in children with a transplanted heart

Drug: Dexmedetomidine

Fontan procedure

EXPERIMENTAL

diagnostic cardiac catheterization in children with a transplanted ventricle

Drug: Dexmedetomidine

Normal Physiology

OTHER

diagnostic cardiac catheterization in children with normal cardiac physiology

Drug: Dexmedetomidine

Interventions

DexmedetomidineDRUG

Dexmedetomidine load of 1 microgram/kilogram over 10 minutes, followed by a 1 microgram/kilogram/hour infusion during the time of catheterization

Also known as: Precedex
Cardiac TransplantFontan procedureNormal Physiology

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • age is birth to 18 years
  • \> or = 6 kg.
  • American Society of Anesthesiology (ASA) I, II, or III
  • undergone prior cardiac transplant, Fontan or has a patent ductus arterious or atrial septal defect.
  • scheduled for cardiac catheterization

You may not qualify if:

  • subject or family history of malignant hyperthermia
  • known hepatic disorder determined by history physical exam or laboratory tests
  • pregnant or lactating female
  • receiving inotropic agents or has a pacemaker
  • weighs less than 6 kg.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's National Medical Center

Washington D.C., District of Columbia, 20010, United States

Location

Related Publications (2)

  • Finkel JC, Johnson YJ, Quezado ZM. The use of dexmedetomidine to facilitate acute discontinuation of opioids after cardiac transplantation in children. Crit Care Med. 2005 Sep;33(9):2110-2. doi: 10.1097/01.ccm.0000178183.21883.23.

    PMID: 16148487BACKGROUND

  • Finkel JC, Elrefai A. The use of dexmedetomidine to facilitate opioid and benzodiazepine detoxification in an infant. Anesth Analg. 2004 Jun;98(6):1658-1659. doi: 10.1213/01.ANE.0000113547.34160.A5.

    PMID: 15155322BACKGROUND

MeSH Terms

Conditions

Heart Septal Defects, AtrialHeart Defects, Congenital

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

Heart Septal DefectsCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title
Dr. Julia Finkel
Organization
Children's National Medical Center
jfinkel@childrensnational.org
202-476-4867

Study Officials

  • Julia C Finkel, MD

    Children's National Research Institute

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

May 29, 2007

First Posted

May 31, 2007

Study Start

December 1, 2006

Primary Completion

October 1, 2011

Study Completion

October 1, 2011

Last Updated

June 26, 2015

Results First Posted

June 26, 2015

Record last verified: 2015-06

Locations

US(1)