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Vasopressin and Inhaled Prostacyclin in Pediatric Pulmonary Hypertension
Plain-language guide to NCT01370096: phase 2 interventional trial of Vasopressin, 3 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01370096
- Phase
- phase 2
- Status
- terminated early
- Start
- 2012-02
- Completion (planned or actual)
- 2016-09
- Participants
- 3 (actual)
- Design
- na, open label (everyone knows who gets what), treatment
- Conditions studied
- Pulmonary Hypertension
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
In this phase 2 trial, researchers set out to test Vasopressin.
To diagnose pulmonary hypertension, children have a cardiac catheterization to check the blood pressure in their lungs.
Children with pulmonary hypertension have high blood pressure in their lungs.
The right ventricle of the heart has to do more work to pump against this higher pressure.
The registry classes the interventions as drug.
More on the Plan
Background: Pulmonary hypertension (PH) is a rare, but devastating disease that affects both adult and pediatric patients.
The resuscitation of patients with PH after cardiac arrest is extremely difficult.
The use of epinephrine, a pulmonary vasoconstrictor, during resuscitation may impair filling of the left ventricle.
The ideal resuscitation drug(s) would dilate the pulmonary vascular bed to help fill the left ventricle while constricting the systemic vascular bed to maintain coronary perfusion.
Who Took Part
Enrollment: 3 actual participants took part.
It was open to people of any sex aged up to 18 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
The full record lists 0 inclusion and 2 exclusion criteria; among the exclusions: any patient with known pulmonary veno-occlusive disease.
How the Study Was Run
It was run as a single-group and open-label study.
Nothing was hidden in this open-label Vasopressin study: the participants and staff both knew the treatment.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2012-02 with completion listed for 2016-09.
It ran at 1 site in Canada.
Its stated primary purpose is treatment.
What Was Measured
Researchers chose this as the main measure: PVR/SVR indexed ratio (time frame: Within 15 minutes of intervention).
What This Means in Plain Language
Put simply, this is a phase 2 trial of Vasopressin in 3 people.
Its size is small, so on its own it can only give an early look.
It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Vasopressin compound page, all human trials.
Our Notes on the Compound
Vasopressin: A 9-amino-acid hormone (antidiuretic hormone) that controls water balance and blood vessel tone; used in septic shock.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.