Trial Outcomes & Findings for Sedation With Dexmedetomidine During Cardiac Catheterization (NCT NCT01072643)

Results Overview

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

Recruitment status

TERMINATED

Study phase

PHASE2/PHASE3

Target enrollment

4 participants

Primary outcome timeframe

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

Results posted on

2019-04-16

Participant Flow

22 patients were screened, but 18 were determined to be not feasible, only 4 participants were enrolled and started the study at drug level 1 (bolus of 1mcg/kg and infusion at 0.7mcg/kg/hr); There was no escalation to either dose level 2 or dose level 3 as we did not reach enrollment target of 8 subjects in dose level 1

Participant milestones

Participant milestones
Measure	Dexmedetomidine (DEX) 1 mcg/kg Bolus To study safety of Dexmedetomidine (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 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.
Overall Study STARTED	4
Overall Study COMPLETED	4
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Sedation With Dexmedetomidine During Cardiac Catheterization

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dexmedetomidine n=4 Participants 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 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.
Age, Categorical <=18 years	3 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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

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

Outcome measures

Outcome measures
Measure	Subject 1 n=1 Participants Pulmonary vascular resistance (PVR) in Wood units calculated during cardiac catheterization	Subject 2 n=1 Participants Pulmonary vascular resistance (PVR) in Wood units calculated during cardiac catheterization	Subject 3 n=1 Participants Pulmonary vascular resistance (PVR) in Wood units calculated during cardiac catheterization	Subject 4 n=1 Participants Pulmonary vascular resistance (PVR) in Wood units calculated during cardiac catheterization
The Primary Endpoint Will be the Change in PVR in Wood Units T0	8.9 wood units	13.7 wood units	5.45 wood units	8.57 wood units
The Primary Endpoint Will be the Change in PVR in Wood Units T1	9.7 wood units	15.5 wood units	6.52 wood units	13.18 wood units
The Primary Endpoint Will be the Change in PVR in Wood Units T2	7.1 wood units	15.5 wood units	7.0 wood units	2.27 wood units

SECONDARY outcome

Timeframe: 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

Population: The study was terminated early due to increased pulmonary vascular resistance (PVR) in one subject from To-T1 reaching the level of a predetermined stopping rule. Investigators suggested that it is premature to conclude that DEX does not adversely affect PVR.

The study was terminated early due to increased pulmonary vascular resistance (PVR) in one subject from To-T1 reaching the level of a predetermined stopping rule. Investigators suggested that it is premature to conclude that DEX does not adversely affect PVR

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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

Population: The study was terminated early due to increased pulmonary vascular resistance (PVR) in one subject from To-T1 reaching the level of a predetermined stopping rule. Investigators suggested that it is premature to conclude that DEX does not adversely affect PVR

The study was terminated early due to increased pulmonary vascular resistance (PVR) in one subject from To-T1 reaching the level of a predetermined stopping rule. Investigators suggested that it is premature to conclude that DEX does not adversely affect PVR

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 hours

Population: The study was terminated early due to increased pulmonary vascular resistance (PVR) in one subject from To-T1 reaching the level of a predetermined stopping rule. Investigators suggested that it is premature to conclude that DEX does not adversely affect PVR.

The study was terminated early due to increased pulmonary vascular resistance (PVR) in one subject from To-T1 reaching the level of a predetermined stopping rule. Investigators suggested that it is premature to conclude that DEX does not adversely affect PVR

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 hours

Population: The study was terminated early due to increased pulmonary vascular resistance (PVR) in one subject from To-T1 reaching the level of a predetermined stopping rule. Investigators suggested that it is premature to conclude that DEX does not adversely affect PVR.

The study was terminated early due to increased pulmonary vascular resistance (PVR) in one subject from To-T1 reaching the level of a predetermined stopping rule. Investigators suggested that it is premature to conclude that DEX does not adversely affect PVR.

Outcome measures

Outcome data not reported

Adverse Events

Dexmedetomidine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Aruna T. Nathan

The Children's Hospital of Philadelphia

Phone: 215-590-1858

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place