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Completed

NCT Number: NCT02975999

Use of Vasopressin Following the Fontan Operation

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.

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Key information

Conditions

Pleural Effusion Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases Pleural Diseases Respiratory Tract Diseases Single-ventricle Univentricular Heart

Age range

18 month–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Advocate Children's Hospital

Oak Lawn, Illinois, 60453, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Vasostrict, arginine

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.

Other names: Placebo

Primary outcomes

  1. Chest Tube Drainage

    Time frame: From post operative day 0 through study completion, an average of 1 month

    chest tube drainage until the day the chest tube is removed

Secondary outcomes

  1. Length of Hospital Stay

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

    Duration the patient remains in the hospital in days until the day of discharge home

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Official study title

Use of Vasopressin Following the Fontan Operation: Both Pilot and Multicenter Studies

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Nov 29, 2016
Registry last updated
Oct 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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