A Phase 2/3 interventional study of Vasopressin and Normal Saline in Pleural Effusion and Single-ventricle, sponsored by Wake Forest University Health Sciences. Completed at 1 site in United States. Open to participants aged 18 Months to 7 Years. Per ClinicalTrials.gov, last updated 2024-10-24.
Sponsored by Wake Forest University Health Sciences · Phase 2/3, Interventional, and Treatment
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.
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.
324 studies on the registry are indexed under Pleural Effusion; 62 are open to participants now.
This study's enrollment of 12 is below the median of 63 across 212 interventional studies indexed under Pleural Effusion.
Browse Pleural Effusion studies →Wake Forest University Health Sciences is the lead sponsor of 1,320 studies on the registry; 199 are open to participants now.
Of its 323 completed or terminated interventional studies of FDA-regulated products, 243 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Vasopressin at 0.4mU/kg/min
Drug: Vasopressin
Normal saline will be provided on a drip infusion to the selected group once coming off cardiopulmonary bypass following the Fontan operation.
Drug: Normal Saline
Vasopressin at dose of 0.4mU/kg/min will be started on the assigned group once coming off cardiopulmonary bypass following the Fontan operation.
Also known as: Vasostrict, arginine
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.
Also known as: Placebo
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
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
| Milestone | Vasopressin | Normal Saline |
|---|---|---|
| Started | 6 | 6 |
| Completed | 6 | 6 |
| Not completed | 0 | 0 |
chest tube drainage until the day the chest tube is removed
| ml/kg | Vasopressin | Normal Saline |
|---|---|---|
| Chest Tube Drainage | 686.83 ± 307.03 | 535.50 ± 140.29 |
Duration the patient remains in the hospital in days until the day of discharge home
| days | Vasopressin | Normal Saline |
|---|---|---|
| Length of Hospital Stay | 5 ± 1.7 | 4.5 ± 0.8 |
Collected over Through study completion, an average of 3 years.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Vasopressin | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) |
| Normal Saline | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) |
| Age, Categorical(Participants) | Vasopressin | Normal Saline | Total |
|---|---|---|---|
| <=18 years | 6 | 6 | 12 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Vasopressin | Normal Saline | Total |
|---|---|---|---|
| Mean | 6 ± 1 | 5 ± 1 | 5 ± 1 |
| Sex: Female, Male(Participants) | Vasopressin | Normal Saline | Total |
|---|---|---|---|
| Female | 4 | 0 | 4 |
| Male | 2 | 6 | 8 |
| Race and Ethnicity Not Collected(Participants) | Vasopressin | Normal Saline | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(Participants) | Vasopressin | Normal Saline | Total |
|---|---|---|---|
| United States | 6 | 6 | 12 |
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Plan to share: No
This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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Wake Forest University Health Sciences