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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vasopressin | Experimental | Vasopressin at 0.4mU/kg/min |
|
| Normal saline | Placebo Comparator | Normal saline will be provided on a drip infusion to the selected group once coming off cardiopulmonary bypass following the Fontan operation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vasopressin | Drug | Vasopressin at dose of 0.4mU/kg/min will be started on the assigned group once coming off cardiopulmonary bypass following the Fontan operation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Chest Tube Drainage | chest tube drainage until the day the chest tube is removed | From post operative day 0 through study completion, an average of 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Length of Hospital Stay | Duration the patient remains in the hospital in days until the day of discharge home | From the day of the surgery (post operative day 0) through study completion, an average of 1 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jamie Penk, MD | Advocate Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Advocate Children's Hospital | Oak Lawn | Illinois | 60453 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Normal Saline |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Chest Tube Drainage | chest tube drainage until the day the chest tube is removed | Posted | Mean | Standard Deviation | ml/kg | From post operative day 0 through study completion, an average of 1 month |
|
Through study completion, an average of 3 years.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jamie Penk, co-investigator | LUrie Children's Hospital | 7735773782 | jpenk@luriechildrens.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 29, 2016 | Sep 18, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010996 | Pleural Effusion |
| D000080039 | Univentricular Heart |
| ID | Term |
|---|---|
| D010995 | Pleural Diseases |
| D012140 | Respiratory Tract Diseases |
| D006330 | Heart Defects, Congenital |
| D018376 | Cardiovascular Abnormalities |
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| ID | Term |
|---|---|
| D014667 | Vasopressins |
| D001127 | Arginine Vasopressin |
| D001120 | Arginine |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D010909 | Pituitary Hormones, Posterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
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|
| Normal Saline | Drug | 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. |
|
|
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.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
| Secondary | Length of Hospital Stay | Duration the patient remains in the hospital in days until the day of discharge home | Posted | Mean | Standard Deviation | days | From the day of the surgery (post operative day 0) through study completion, an average of 1 month |
|
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | 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. | 0 | 6 | 0 | 6 | 0 | 6 |
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| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
| D024361 | Amino Acids, Basic |
| D000596 | Amino Acids |
| D000599 | Amino Acids, Diamino |
| D000601 | Amino Acids, Essential |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |