Sedation With Dexmedetomidine During Cardiac Catheterization

NCT01072643 | Terminated Phase 2 Results DMC

• 1 other identifier: 09-007076
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

Clinical dose escalation drug trial to evaluate the effect of 3 different doses of dexmedetomidine on the pulmonary vascular bed in pediatric subjects with elevated pulmonary vascular resistance (PVR). The study will be conducted in 2 parts, with part 1 incorporating stopping rules to optimize safety of the drug in this population. The second part of this study will evaluate if the lowest safest dose, as determined in part 1, is adequate to provide effective sedation during a cardiac catheterization procedure.

Conditions

Pulmonary Hypertension

Keywords

Sedation; Pulmonary Hypertension; Pediatric; Cardiac Catheterization; Pulmonary Vascular Resistance

Outcome Measures

Primary Outcomes (1)

• The Primary Endpoint Will be the Change in PVR in Wood Units

  Pulmonary vascular resistance (PVR) in Wood units calculated during cardiac catheterization;

  For each subject PVR will be measured by cardiac catheterization at T0 ( baseline measurement) , after DEX bolus (T1) which is given over 10 minutes and after 30 mins after start of the DEX infusion (T2) - Maximum upto 4 hours

Secondary Outcomes (4)

• Efficacy of Sedation With DEX

  Subjects will participate in a dose escalation study which will define minimal effective dose that results in effective sedation in ≥ 7 out of 8 patients in that dose cohort. Maximum upto 4 hours

• Quantify the Effect of DEX on PVR in Pediatric Subjects With Pulmonary Hypertension (PHTN) and Its Dependence on Baseline PVR

  Every individual patient will be studied over maximum of 4 hours during the dose escalation phase. This part of the study will be completed in 1 year

• Obtain Pharmacokinetic Data in This Population

  6 hours

• Demonstrate That DEX is a Safe Sedative in Pediatric Subjects With PHTN

  24 hours

Study Arms (1)

Dexmedetomidine

EXPERIMENTAL

To study safety of DEX with regard to effect on PVR; There will be 3 study groups (n=8 per group). The groups will be based on DEX doses as follows- Group 1 - Bolus 1 mcg/kg followed by infusion 0.7 mcg/kg/hr Group 2 - Bolus 1.5 mcg/kg followed by infusion 1.05 mcg/kg/hr Group 3 - Bolus 2 mcg/kg followed by infusion 1.4 mcg/kg/hr

Drug: Dexmedetomidine

Interventions

Dexmedetomidine DRUG

This is a single center, dose escalation study of Dexmedetomidine in pediatric subjects with pulmonary hypertension (PVR\>4WU) undergoing hemodynamic cardiac catheterization and vasoreactivity drug testing. Cohorts of 8 evaluable subjects will receive dose level 1, dose level 2, or dose level 3 of Dexmedetomidine.

Also known as: Precedex

Dexmedetomidine

Eligibility Criteria

• Age: 8 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Subjects with a diagnosis of pulmonary hypertension
• Procedure - Planned cardiac catheterization procedure with spontaneous ventilation and natural airway
• Patients who want sedation or general anesthetic for the procedure.
• Age: Subjects ≥8 years and \< 21 years
• Adequate Renal Function defined As:Serum creatinine ≤ 1 mg/dL
• Adequate Liver Function defined As:Total bilirubin ≤ 1.5 mg/dL alanine aminotransferase (ALT) ≤ 2 times the upper limit of normal
• Informed Consent: All parents or legal guardians must sign a written informed consent.
• Signed assent when developmentally appropriate
• Negative pregnancy test in menstruating females and all females ≥ 12 yr

You may not qualify if:

• Refusal of Informed Consent/Assent
• Subjects with single ventricle physiology
• Pregnant or lactating females
• Subjects with syndromes e.g. Trisomy 21 will be excluded due to variability in pharmacodynamic responses and airway instability during sedation
• Inappropriate clinical or developmental status to undergo cardiac catheterization under conditions of spontaneous ventilation with a natural airway
• Second or third degree heart block
• Moderate - severe right ventricular dysfunction/failure
• Subjects who, in the opinion of the investigator, are not appropriate candidates for an investigational drug study e.g. behavioral or anxiety disorders, inability to lie supine
• Concomitant Medications - Investigational Drugs: Subjects who have received another investigational drug protocol 30 days prior to enrollment in this study
• Subjects who in the opinion of the investigator may be non compliant with study schedules or procedures.
• Non-English speaking subjects will be excluded due to need for direct communication from clinical and study staff during study procedures and the ability to complete study tools.

Sponsors & Collaborators

• Aruna Nathan: lead
• Children's Hospital of Philadelphia: collaborator

Study Sites (1)

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Hypertension, Pulmonary

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Aruna T. Nathan
• Organization: The Children's Hospital of Philadelphia

aruna.nathan@gmail.com

215-590-1858

Study Officials

• Aruna T Nathan, MBBS

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Attending Physician

Study Record Dates

• First Submitted: February 15, 2010
• First Posted: February 22, 2010
• Study Start: March 1, 2010
• Primary Completion: March 1, 2013
• Study Completion: April 1, 2013
• Last Updated: April 16, 2019
• Results First Posted: September 8, 2014

Record last verified: 2019-04

Locations

US (1)