Use of Vasopressin Following the Fontan Operation

NCT02975999 | Completed Phase 2 Results DMC

• 1 other identifier: HRP-530
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Pleural Effusion; Single-ventricle

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Length of Hospital Stay

  From the day of the surgery (post operative day 0) through study completion, an average of 1 month

Study Arms (2)

Vasopressin

EXPERIMENTAL

Vasopressin at 0.4mU/kg/min

Drug: Vasopressin

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.

Drug: Normal Saline

Interventions

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.

Also known as: Vasostrict, arginine

Vasopressin

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.

Also known as: Placebo

Normal saline

Eligibility Criteria

• Age: 18 Months - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Subjects between 1.5-7 years old undergoing Fontan operation.

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Advocate Children's Hospital

Oak Lawn, Illinois, 60453, United States

Location

MeSH Terms

Conditions

Pleural Effusion; Univentricular Heart

Interventions

Vasopressins; Arginine Vasopressin; Arginine; Saline Solution

Condition Hierarchy (Ancestors)

Pleural Diseases; Respiratory Tract Diseases; Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Amino Acids, Basic; Amino Acids; Amino Acids, Diamino; Amino Acids, Essential; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Dr. Jamie Penk, co-investigator
• Organization: LUrie Children's Hospital

jpenk@luriechildrens.org

7735773782

Study Officials

• Jamie Penk, MD

  Advocate Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2016
• First Posted: November 29, 2016
• Study Start: December 1, 2016
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: October 24, 2024
• Results First Posted: October 9, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)