Sedation With Dexmedetomidine During Cardiac Catheterization
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Pulmonary Hypertension |
Drug: Dexmedetomidine |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | The Pharmacodynamics, Safety, and Pharmacokinetics of Sedation With Dexmedetomidine in Children Undergoing Hemodynamic Cardiac Catheterization With Special Reference to the Pulmonary Vascular Bed |
- The Primary endpoint will be the change in PVR in Wood units [ Time Frame: 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 ] [ Designated as safety issue: Yes ]
- Efficacy of sedation with DEX [ Time Frame: 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 ] [ Designated as safety issue: Yes ]
- To quantify the effect of DEX on PVR in pediatric subjects with pulmonary hypertension and its dependence on baseline PVR [ Time Frame: 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 ] [ Designated as safety issue: Yes ]
- To obtain pharmacokinetic data in this population [ Time Frame: 6 hours ] [ Designated as safety issue: Yes ]
- To demonstrate that DEX is a safe sedative in pediatric subjects with PHTN [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 80 |
| Study Start Date: | March 2010 |
| Estimated Study Completion Date: | March 2013 |
| Estimated Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Dexmedetomidine
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
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.
Other Name: Precedex
|
Detailed Description:
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. The study will be conducted in 2 parts, with a pilot phase incorporating stopping rules to optimize safety of the drug in this population. Study subjects will include pediatric subjects with Pulmonary Hypertension (PHTN).
Part 1: This will be the dose escalation phase of the study. Twenty four evaluable subjects will be enrolled. Subjects will include 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. The dose will be escalated to the next dose of DEX once all subjects have been enrolled in the preceding DEX dose cohort, and safety has been established at that level. Inadequate sedation despite the highest dose of DEX at each level will be considered a treatment failure on an intention to treat basis. Part 2: This part of the study will be conducted after the pilot phase is safely completed, and the full complement of subjects will be recruited.
Eligibility| Ages Eligible for Study: | 8 Years to 21 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Contacts and Locations| Contact: Aruna T Nathan, MBBS | 215-590-1858 | nathan@email.chop.edu |
| United States, Pennsylvania | |
| The Children's Hospital of Philadelphia | Recruiting |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Principal Investigator: | Aruna T Nathan, MBBS | Children's Hospital of Philadelphia |
More Information
No publications provided
| Responsible Party: | Aruna Nathan, Attending Physician, Children's Hospital of Philadelphia |
| ClinicalTrials.gov Identifier: | NCT01072643 History of Changes |
| Other Study ID Numbers: | 09-007076 |
| Study First Received: | February 15, 2010 |
| Last Updated: | January 9, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Children's Hospital of Philadelphia:
|
Sedation Pulmonary Hypertension Pediatric Cardiac Catheterization Pulmonary Vascular Resistance |
Additional relevant MeSH terms:
|
Hypertension Hypertension, Pulmonary Vascular Diseases Cardiovascular Diseases Lung Diseases Respiratory Tract Diseases Dexmedetomidine Hypnotics and Sedatives Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents |
Therapeutic Uses Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Adrenergic alpha-2 Receptor Agonists Adrenergic alpha-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 19, 2013