At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 12 enrolled
Drug / intervention
Vasopressin +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Use of Vasopressin Following the Fontan Operation: Both Pilot and Multicenter Studies
In Brief
A Phase 3 clinical trial evaluating Vasopressin and Normal Saline for Pleural Effusion and Single-ventricle. Completed, enrolled 12 participants across 1 site.
Detailed Summary
The purpose of this pilot study is to prepare for a larger study to determine whether Vasopressin following the Fontan operation will decrease chest tube output and duration.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPleural Effusion, Single-ventricle
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedNov 2016
Enrollment StartDec 2016
Primary CompletionDec 2019
TodayJul 2026
First PostedNov 29, 2016
Enrollment StartDec 1, 2016
Primary CompletionDec 1, 2019
TodayJul 2, 2026
Enrollment to primary: 3 yearsPosted 9.6 years ago
Interventions
Vasopressindrug
Vasopressin at dose of 0.4mU/kg/min will be started on the assigned group once coming off cardiopulmonary bypass following the Fontan operation.
Normal Salinedrug
Normal saline at starting dose of 0.4mU/kg/min will be started on the assigned group once coming off cardiopulmonary bypass following the Fontan operation.