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Use of Vasopressin Following the Fontan Operation

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ClinicalTrials.gov Identifier: NCT02975999
Recruitment Status : Suspended (Pilot study is finished, multi centered is awaiting funding)
First Posted : November 29, 2016
Last Update Posted : January 12, 2018
Sponsor:
Information provided by (Responsible Party):
Jamie Penk, Advocate Health Care

Brief Summary:
The purpose of this study is to determine whether Vasopressin following the Fontan operation will decrease chest tube output and duration.

Condition or disease Intervention/treatment Phase
Pleural Effusion Single-ventricle Drug: Vasopressin Drug: Normal Saline Phase 2 Phase 3

Detailed Description:

A pilot and subsequently a multicenter, 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.

The multicenter study will be phase two and will be conducted in the cardiac operating rooms and cardiac intensive care unit (CVICU) of 7 pediatric cardiovascular programs in the United States. The investigators will be enrolling 12 subjects undergoing the Fontan operation from each participating institution. Six patients will be randomly assigned to receive Vasopressin while six will receive placebo.

A total of 84 patients undergoing the Fontan operation will be included in the study and randomized to one of the two treatment groups.

Group 1 will include 42 subjects who will receive the treatment drug (Vasopressin) for 48 hours following the Fontan operation. Group 2 will include 42 subjects who will receive placebo (normal saline) and will serve as a control group.

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Use of Vasopressin Following the Fontan Operation: Both Pilot and Multicenter Studies
Study Start Date : December 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Vasopressin

Arm Intervention/treatment
Experimental: Vasopressin
Vasopressin at 0.4mU/kg/min
Drug: 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.
Other Name: Vasostrict, arginine

Placebo Comparator: Normal saline
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
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 Name: Placebo




Primary Outcome Measures :
  1. Chest tube drainage [ Time Frame: From post operative day 0 through study completion, an average of 1 month ]
    chest tube drainage in ml/kg/day until the day the chest tube is removed


Secondary Outcome Measures :
  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



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Ages Eligible for Study:   18 Months to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02975999


Locations
United States, Illinois
Advocate Children's Hospital
Oak Lawn, Illinois, United States, 60453
Sponsors and Collaborators
Advocate Health Care

Responsible Party: Jamie Penk, Pediatric Cardiologist, Advocate Health Care
ClinicalTrials.gov Identifier: NCT02975999     History of Changes
Other Study ID Numbers: HRP-530
First Posted: November 29, 2016    Key Record Dates
Last Update Posted: January 12, 2018
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Pleural Effusion
Pleural Diseases
Respiratory Tract Diseases
Vasopressins
Arginine Vasopressin
Hemostatics
Coagulants
Vasoconstrictor Agents
Antidiuretic Agents
Natriuretic Agents
Physiological Effects of Drugs