Pleural Effusion, Single-ventricle
Conditions
Brief 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.
Detailed description
A pilot 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. 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.
Interventions
DRUGVasopressin
Vasopressin at dose of 0.4mU/kg/min will be started on the assigned group once coming off cardiopulmonary bypass following the Fontan operation.
DRUGNormal 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.
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Months to 7 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Chest Tube Drainage | From post operative day 0 through study completion, an average of 1 month | chest tube drainage until the day the chest tube is removed |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of Hospital Stay | From the day of the surgery (post operative day 0) through study completion, an average of 1 month | Duration the patient remains in the hospital in days until the day of discharge home |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 6 |
| 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. | 6 |
| Total | 12 |
Baseline characteristics
| Characteristic | Normal Saline | Total | Vasopressin |
|---|---|---|---|
| Age, Categorical <=18 years | 6 Participants | 12 Participants | 6 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 5 years STANDARD_DEVIATION 1 | 5 years STANDARD_DEVIATION 1 | 6 years STANDARD_DEVIATION 1 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 6 Participants | 12 Participants | 6 Participants |
| Sex: Female, Male Female | 0 Participants | 4 Participants | 4 Participants |
| Sex: Female, Male Male | 6 Participants | 8 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 6 |
| other Total, other adverse events | 0 / 6 | 0 / 6 |
| serious Total, serious adverse events | 0 / 6 | 0 / 6 |
Outcome results
Primary
Chest Tube Drainage
chest tube drainage until the day the chest tube is removed
Time frame: From post operative day 0 through study completion, an average of 1 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vasopressin | Chest Tube Drainage | 686.83 ml/kg | Standard Deviation 307.03 |
| Normal Saline | Chest Tube Drainage | 535.50 ml/kg | Standard Deviation 140.29 |
Secondary
Length of Hospital Stay
Duration the patient remains in the hospital in days until the day of discharge home
Time frame: From the day of the surgery (post operative day 0) through study completion, an average of 1 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vasopressin | Length of Hospital Stay | 5 days | Standard Deviation 1.7 |
| Normal Saline | Length of Hospital Stay | 4.5 days | Standard Deviation 0.8 |