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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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4 November 2024 |
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Main ID: |
NCT02975999 |
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Date of registration:
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22/09/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Use of Vasopressin Following the Fontan Operation
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Scientific title:
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Use of Vasopressin Following the Fontan Operation: Both Pilot and Multicenter Studies |
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Date of first enrolment:
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December 2016 |
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Target sample size:
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12 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT02975999 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 2/Phase 3
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Countries of recruitment
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United States
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Contacts
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Name:
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Jamie Penk, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Advocate Health |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Months
Age maximum:
7 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Single-ventricle
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Pleural Effusion
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Intervention(s)
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Drug: Vasopressin
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Drug: Normal Saline
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Primary Outcome(s)
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Chest Tube Drainage
[Time Frame: From post operative day 0 through study completion, an average of 1 month]
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Secondary Outcome(s)
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Length of Hospital Stay
[Time Frame: From the day of the surgery (post operative day 0) through study completion, an average of 1 month]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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