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Early Use of Vasopressin in Post-Fontan Management (VAMP)

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ClinicalTrials.gov Identifier: NCT03088345
Recruitment Status : Recruiting
First Posted : March 23, 2017
Last Update Posted : May 14, 2018
Sponsor:
Information provided by (Responsible Party):
Amee Bigelow, Medical College of Wisconsin

Brief Summary:
This is an investigator initiated, prospective, single-center, double-blinded, randomized, placebo-controlled trial of post-operative low dose vasopressin infusions as an early treatment of low systemic perfusion in pediatric patients following Fontan palliation.

Condition or disease Intervention/treatment Phase
Circulatory Perfusion Disorder Congenital Heart Disease Single-ventricle Drug: Vasopressin, Arginine Drug: Placebos Phase 2 Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Use of Arginine Vasopressin in Early Postoperative Management After Fontan Palliation
Actual Study Start Date : March 6, 2017
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : December 2020


Arm Intervention/treatment
Experimental: Vasopressin, Arginine
Patients randomized to this arm will receive a continuous arginine vasopressin infusion immediately following the modified ultrafiltration (MUF) period of their cardiac surgery.
Drug: Vasopressin, Arginine
Subjects will be started on a blinded continuous infusion of study drug/placebo in the OR, immediately following the completion of the MUF at 0.3 mU/kg/min. All caregivers will be blinded to the arm assignment. The infusion will run for 20 hours, at which time it will be weaned off at 0.1 mU/hr, over 3 hours.During the active study period, the care team will treat subjects per SOC, using any preferred medication to correct low cardiac output; there is no restriction on using open-label vasopressin during the active study treatment period.

Placebo Comparator: Placebo
Patients randomized to this arm will receive a continuous normal saline infusion immediately following the modified ultrafiltration (MUF) period of their cardiac surgery.
Drug: Placebos
Subjects will be started on a blinded continuous infusion of study drug/placebo in the OR, immediately following the completion of the MUF at 0.3 mU/kg/min. All caregivers will be blinded to the arm assignment. The infusion will run for 20 hours, at which time it will be weaned off at 0.1 mU/hr, over 3 hours.During the active study period, the care team will treat subjects per SOC, using any preferred medication to correct low cardiac output; there is no restriction on using open-label vasopressin during the active study treatment period.
Other Name: Normal Saline




Primary Outcome Measures :
  1. Hemodynamics as characterized by vasoactive inotrope score (VIS) [ Time Frame: 48 hours post-operative ]
    VIS will be calculated hourly for all subjects and compared between groups.

  2. Hemodynamics as characterized by organ perfusion pressure [ Time Frame: 24 hours post-operative ]
    Organ perfusion pressure measured as Mean Arterial Pressure (MAP) minus Central Venous Pressure (CVP) will be measured every 15 minutes for the first 12hours post-operatively and then hourly for an additional 12 hours for all subjects and compared between the two study groups.

  3. Hemodynamics as characterized by transpulmonary pressure gradient [ Time Frame: 24 hours post-operative ]
    The transpulmonary pressure gradient (TPG), defined as the difference between mean pulmonary arterial pressure(Ppa) and left atrial (common atrial) pressure (Pla) will be measured every 15minutes for the first 12 hours and then hourly for an additional 12hours for all subjects and compared between the two study groups.

  4. Hemodynamics as characterized by regional oximetry differences [ Time Frame: 48 hours post-operative ]
    Regional oximetry will be used, as is standard at our institution of using two patches (cerebral and renal) of near infrared spectroscopy which will be measured every 15minutes for the first 12hours and then hourly for an additional 12hours for all subjects and compared between the two study groups.


Secondary Outcome Measures :
  1. Renal function characterized by the presence of oliguria [ Time Frame: 24 hour post-operative ]
    Urine output to be measured in ml/kg/hr for all subjects, with oliguria defined as output <0.4 ml/kg/hr x4 hours.

  2. Renal dysfunction as characterized by cystatin level [ Time Frame: 48 hours post-operatively ]
    Cystatin levels will be measured pre-operatively and at 48 hours and a change in level will be compared between groups.

  3. Liver dysfunction as characterized by transaminase levels [ Time Frame: 48 hours post-operative ]
    Transaminase levels (alanine and aspartate, measured in IU/L ) will be tracked for all patients and changes will be compared between study groups.

  4. Fluid Balance [ Time Frame: 48 hours post-operative ]
    Hourly fluid intake and output will be measured in ml/kg/hr and compared between groups to determine if fluid balance is equal between groups.


Other Outcome Measures:
  1. Resource Utilization measured by length of stay (LOS) [ Time Frame: 48 hours postoperative ]
    LOS measured in days compared between group

  2. Change in Vasopressin Levels [ Time Frame: 48 hours postoperative ]
    Arginine Vasopressin levels to be measured 5 separate times from the preoperative period to 48 hours post-operative, timed levels will be compared between groups, as well as change in levels between groups.



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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Planned completion of Fontan palliation
  • English or Spanish speaking
  • Completion of Informed Consent

Exclusion Criteria:

  • Previous failed attempts at Fontan completion with subsequent takedown
  • Planned concomitant atrioventricular valvuloplasty or neoaortic valve or arch reconstruction at the time of Fontan completion
  • History of renal failure requiring renal replacement therapy
  • Absence of informed consent

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): NCT03088345


Contacts
Contact: Amee Bigelow, MD 414-266-4730 abigelow@mcw.edu
Contact: Nancy Ghanayem, MD 414-266-3938 nxghanay@texaschildrens.org

Locations
United States, Wisconsin
Children's Hospital of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Amee Bigelow, MD    414-266-4730    abigelow@mcw.edu   
Sponsors and Collaborators
Medical College of Wisconsin
Investigators
Principal Investigator: George Hoffman, MD Medical College of Wisconsin

Publications:

Responsible Party: Amee Bigelow, Professor, Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT03088345     History of Changes
Other Study ID Numbers: IRBNet 885148
First Posted: March 23, 2017    Key Record Dates
Last Update Posted: May 14, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Amee Bigelow, Medical College of Wisconsin:
Fontan Palliation Surgery
Post-Operative Care

Additional relevant MeSH terms:
Heart Diseases
Cardiovascular Diseases
Vasopressins
Arginine Vasopressin
Hemostatics
Coagulants
Vasoconstrictor Agents
Antidiuretic Agents
Natriuretic Agents
Physiological Effects of Drugs