Use of Vasopressin Following the Fontan Operation
| Status: | Suspended |
|---|---|
| Conditions: | Cardiology, Pulmonary |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | Any - 7 |
| Updated: | 1/14/2018 |
| Start Date: | December 2016 |
| End Date: | December 2019 |
Use of Vasopressin Following the Fontan Operation: Both Pilot and Multicenter Studies
The purpose of this study is to determine whether Vasopressin following the Fontan operation
will decrease chest tube output and duration.
will decrease chest tube output and duration.
A pilot and subsequently a multicenter, randomized, double blinded clinical trial to evaluate
the use of vasopressin following the Fontan operation.
Phase one of the study will be a single center pilot study and will be conducted at Advocate
Children's Hospital, Oak Lawn IL. This will be a randomized and double blinded. Ten patients
will be enrolled with five patients as control group and five receiving Vasopressin.
Vasopressin levels will be obtained just prior to initiation of Vasopressin and 48 hours
later in the pilot study. Safety and effect size will be evaluated after this pilot study.
The multicenter study will be phase two and will be conducted in the cardiac operating rooms
and cardiac intensive care unit (CVICU) of 7 pediatric cardiovascular programs in the United
States. The investigators will be enrolling 12 subjects undergoing the Fontan operation from
each participating institution. Six patients will be randomly assigned to receive Vasopressin
while six will receive placebo.
A total of 84 patients undergoing the Fontan operation will be included in the study and
randomized to one of the two treatment groups.
Group 1 will include 42 subjects who will receive the treatment drug (Vasopressin) for 48
hours following the Fontan operation. Group 2 will include 42 subjects who will receive
placebo (normal saline) and will serve as a control group.
Drug administration protocol:
Vasopressin at a dose of 0.4 mU/kg/min will be started on subjects in the study group while
coming off cardiopulmonary bypass. The dose of Vasopressin will not be titrated. Study drug
drip will infuse for 48 hours after which will be discontinued.
The placebo group will be receiving normal saline at the same rate of the vasopressin group.
The treating physician will be blinded.
the use of vasopressin following the Fontan operation.
Phase one of the study will be a single center pilot study and will be conducted at Advocate
Children's Hospital, Oak Lawn IL. This will be a randomized and double blinded. Ten patients
will be enrolled with five patients as control group and five receiving Vasopressin.
Vasopressin levels will be obtained just prior to initiation of Vasopressin and 48 hours
later in the pilot study. Safety and effect size will be evaluated after this pilot study.
The multicenter study will be phase two and will be conducted in the cardiac operating rooms
and cardiac intensive care unit (CVICU) of 7 pediatric cardiovascular programs in the United
States. The investigators will be enrolling 12 subjects undergoing the Fontan operation from
each participating institution. Six patients will be randomly assigned to receive Vasopressin
while six will receive placebo.
A total of 84 patients undergoing the Fontan operation will be included in the study and
randomized to one of the two treatment groups.
Group 1 will include 42 subjects who will receive the treatment drug (Vasopressin) for 48
hours following the Fontan operation. Group 2 will include 42 subjects who will receive
placebo (normal saline) and will serve as a control group.
Drug administration protocol:
Vasopressin at a dose of 0.4 mU/kg/min will be started on subjects in the study group while
coming off cardiopulmonary bypass. The dose of Vasopressin will not be titrated. Study drug
drip will infuse for 48 hours after which will be discontinued.
The placebo group will be receiving normal saline at the same rate of the vasopressin group.
The treating physician will be blinded.
Inclusion Criteria:
- Subjects between 1.5-7 years old undergoing Fontan operation.
Exclusion Criteria:
- Patients with a planned fenestrated Fontan.
- Patients undergoing revision surgery for failing Fontan.
- Evidence of renal insufficiency prior to surgery defined by creatinine >1 mg/dl.
- Planned arch reconstruction at the time of the Fontan procedure
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