Phase 3 N=12 Randomized Quadruple-blind Treatment

Use of Vasopressin Following the Fontan Operation

Pleural Effusion · Single-ventricle

Bottom Line

View on ClinicalTrials.gov: NCT02975999 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2024

Primary outcome: Primary: Chest Tube Drainage — 686.83; 535.50 ml/kg

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Vasopressin (Drug); Normal Saline (Drug)
Age: Pediatric · 0+ yrs
Sex: All
Sponsor: Wake Forest University Health Sciences
Primary completion: Dec 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Chest Tube Drainage	686.83; 535.50	—
SECONDARY Length of Hospital Stay	5; 4.5	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02975999). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.