Trial Outcomes & Findings for Use of Vasopressin Following the Fontan Operation (NCT NCT02975999)
NCT ID: NCT02975999
Last Updated: 2024-10-24
Results Overview
chest tube drainage until the day the chest tube is removed
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
12 participants
Primary outcome timeframe
From post operative day 0 through study completion, an average of 1 month
Results posted on
2024-10-24
Participant Flow
Participant milestones
| Measure |
Vasopressin
Vasopressin at 0.4mU/kg/min
Vasopressin: 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 Saline
Normal saline will be provided on a drip infusion to the selected group once coming off cardiopulmonary bypass following the Fontan operation.
Normal Saline: 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.
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
|
Overall Study
COMPLETED
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
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 |
Vasopressin
n=6 Participants
Vasopressin at 0.4mU/kg/min
Vasopressin: 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 Saline
n=6 Participants
Normal saline will be provided on a drip infusion to the selected group once coming off cardiopulmonary bypass following the Fontan operation.
Normal Saline: 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.
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
12 Participants
n=12 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=12 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=12 Participants
|
|
Age, Continuous
|
6 years
STANDARD_DEVIATION 1 • n=6 Participants
|
5 years
STANDARD_DEVIATION 1 • n=6 Participants
|
5 years
STANDARD_DEVIATION 1 • n=12 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
4 Participants
n=12 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
8 Participants
n=12 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
12 Participants
n=12 Participants
|
PRIMARY outcome
Timeframe: From post operative day 0 through study completion, an average of 1 monthchest tube drainage until the day the chest tube is removed
Outcome measures
| Measure |
Vasopressin
n=6 Participants
Vasopressin at 0.4mU/kg/min
Vasopressin: 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 Saline
n=6 Participants
Normal saline will be provided on a drip infusion to the selected group once coming off cardiopulmonary bypass following the Fontan operation.
Normal Saline: 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.
|
|---|---|---|
|
Chest Tube Drainage
|
686.83 ml/kg
Standard Deviation 307.03
|
535.50 ml/kg
Standard Deviation 140.29
|
SECONDARY outcome
Timeframe: From the day of the surgery (post operative day 0) through study completion, an average of 1 monthDuration the patient remains in the hospital in days until the day of discharge home
Outcome measures
| Measure |
Vasopressin
n=6 Participants
Vasopressin at 0.4mU/kg/min
Vasopressin: 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 Saline
n=6 Participants
Normal saline will be provided on a drip infusion to the selected group once coming off cardiopulmonary bypass following the Fontan operation.
Normal Saline: 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.
|
|---|---|---|
|
Length of Hospital Stay
|
5 days
Standard Deviation 1.7
|
4.5 days
Standard Deviation 0.8
|
Adverse Events
Vasopressin
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Normal Saline
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. Jamie Penk, co-investigator
LUrie Children's Hospital
Phone: 7735773782
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place