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The Hemodynamic Effects of Vasopressin in Patients With Fontan Physiology
Plain-language guide to NCT04463394: early phase 1 interventional trial of Vasopressin, 28 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT04463394
- Phase
- early phase 1
- Status
- completed
- Start
- 2020-08-12
- Completion (planned or actual)
- 2022-02-15
- Participants
- 28 (actual)
- Design
- na, open label (everyone knows who gets what), treatment
- Conditions studied
- Hypotension; Fontan Physiology
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
In this early phase 1 trial, researchers set out to test Vasopressin.
It had 1 arm (groups): Vasopressin (experimental).
Participants undergoing cardiac catheterization.
The registry classes the interventions as drug.
More on the Plan
These patients have changes in venous capacitance, compliance, and venomotor tone.
Vasoconstrictive medications are frequently used to treat hypotension when patients are refractory to fluid resuscitation.
However, most of these medications have an effect on both the systemic and pulmonary circulations, raising the vascular pressures of both circuits.
The ideal agent would be one that raises systemic vascular pressure while having a minimal effect on the pulmonary circulation.
Who Took Part
The registry lists 28 actual participants took part.
It was open to people of any sex.
Healthy volunteers were not accepted; participants needed the condition being studied.
The full record lists 0 inclusion and 4 exclusion criteria; among the exclusions: critical illness severe enough to preclude extended cardiac catheterization time; patients already on vasopressin; patients with pulmonary hypertension.
How the Study Was Run
The set-up was sequential and open-label.
Nothing was hidden in this open-label Vasopressin study: the participants and staff both knew the treatment.
It started in 2020-08-12 with completion listed for 2022-02-15.
It ran at 2 sites in United States (2).
Its stated primary purpose is treatment.
What Was Measured
Researchers chose this as the main measure: Change in systemic (aortic) blood pressure. Change in pulmonary artery pressure. Change in transpulmonary gradient.
What This Means in Plain Language
Put simply, this is a early phase 1 trial of Vasopressin in 28 people.
Its size is small, so on its own it can only give an early look.
The trial is marked completed; 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.