Trial Outcomes & Findings for Management of Acute Pulmonary Hypertensive Crisis in Children With Known Pulmonary Arterial Hypertension (NCT NCT05439460)
NCT ID: NCT05439460
Last Updated: 2022-08-05
Results Overview
In patients with pulmonary hypertension (PH) one anticipates a greater increase in pulmonary vascular resistance as opposed to systemic vascular resistance when vasopressors are administered.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
15 participants
Primary outcome timeframe
Day 1 (at baseline and up to 5 minutes following study drug administration) (Q: 2 minutes - 2 to 5 minutes?)
Results posted on
2022-08-05
Participant Flow
Participants were assigned sequentially; the first group received phenylephrine, the second group received arginine vasopressin, and the third group received epinephrine.
Participant milestones
| Measure |
Phenylephrine
Phenylephrine (1ug/kg) administered once the child is under anesthesia.
|
Arginine Vasopressin
Arginine Vasopressin (1ug/kg) administered once the child is under anesthesia.
|
Epinephrine
Epinephrine (0.5-1ug/kg) administered once the child is under anesthesia.
|
|---|---|---|---|
|
First Intervention (Approx 5h on Study)
STARTED
|
5
|
0
|
0
|
|
First Intervention (Approx 5h on Study)
COMPLETED
|
5
|
0
|
0
|
|
First Intervention (Approx 5h on Study)
NOT COMPLETED
|
0
|
0
|
0
|
|
Second Intervention (Approx 5h on Study)
STARTED
|
0
|
5
|
0
|
|
Second Intervention (Approx 5h on Study)
COMPLETED
|
0
|
5
|
0
|
|
Second Intervention (Approx 5h on Study)
NOT COMPLETED
|
0
|
0
|
0
|
|
Third Intervention (Approx 5h on Study)
STARTED
|
0
|
0
|
5
|
|
Third Intervention (Approx 5h on Study)
COMPLETED
|
0
|
0
|
5
|
|
Third Intervention (Approx 5h on Study)
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Phenylephrine
n=5 Participants
Phenylephrine (1ug/kg) administered once the child is under anesthesia.
|
Arginine Vasopressin
n=5 Participants
Arginine Vasopressin (1ug/kg) administered once the child is under anesthesia.
|
Epinephrine
n=5 Participants
Epinephrine (0.5-1ug/kg) administered once the child is under anesthesia.
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
10.2 years
STANDARD_DEVIATION 3.8 • n=5 Participants
|
10.5 years
STANDARD_DEVIATION 4.9 • n=5 Participants
|
6.8 years
STANDARD_DEVIATION 4.2 • n=5 Participants
|
9.2 years
STANDARD_DEVIATION 4.5 • n=15 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=5 Participants
|
11 Participants
n=15 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=15 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
5 Participants
n=5 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=5 Participants
|
15 Participants
n=15 Participants
|
PRIMARY outcome
Timeframe: Day 1 (at baseline and up to 5 minutes following study drug administration) (Q: 2 minutes - 2 to 5 minutes?)In patients with pulmonary hypertension (PH) one anticipates a greater increase in pulmonary vascular resistance as opposed to systemic vascular resistance when vasopressors are administered.
Outcome measures
| Measure |
Phenylephrine
n=5 Participants
Phenylephrine (1ug/kg) administered once the child is under anesthesia.
|
Arginine Vasopressin
n=5 Participants
Arginine Vasopressin (1ug/kg) administered once the child is under anesthesia.
|
Epinephrine
n=5 Participants
Epinephrine (0.5-1ug/kg) administered once the child is under anesthesia.
|
|---|---|---|---|
|
Change in Systemic Vascular Resistance Index (SVRI) to Pulmonary Vascular Resistance Index (PVRI) Ratio (Rp:Rs Ratio)
Baseline
|
0.8 Rp:Rs ratio
Standard Deviation 0.7
|
0.75 Rp:Rs ratio
Standard Deviation 0.41
|
0.61 Rp:Rs ratio
Standard Deviation 0.23
|
|
Change in Systemic Vascular Resistance Index (SVRI) to Pulmonary Vascular Resistance Index (PVRI) Ratio (Rp:Rs Ratio)
Approx. 2 minutes following drug administration
|
0.73 Rp:Rs ratio
Standard Deviation 0.77
|
0.49 Rp:Rs ratio
Standard Deviation 0.24
|
0.6 Rp:Rs ratio
Standard Deviation 0.34
|
Adverse Events
Phenylephrine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Arginine Vasopressin
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Epinephrine
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Phenylephrine
n=5 participants at risk
Phenylephrine (1ug/kg) administered once the child is under anesthesia.
|
Arginine Vasopressin
n=5 participants at risk
Arginine Vasopressin (1ug/kg) administered once the child is under anesthesia.
|
Epinephrine
n=5 participants at risk
Epinephrine (0.5-1ug/kg) administered once the child is under anesthesia.
|
|---|---|---|---|
|
Cardiac disorders
Transient arrhythmia
|
0.00%
0/5 • During procedure (approx. 5 h)
|
0.00%
0/5 • During procedure (approx. 5 h)
|
40.0%
2/5 • During procedure (approx. 5 h)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place