Post-bypass Prophylactic IVIG in Infants and Neonates

NCT02043379 | Completed Results DMC

• 1 other identifier: F13114002
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study protocol is to determine if administering Intravenous Immunoglobulin (IVIG) for treatment of cardiopulmonary bypass (CPB) induced hypogammaglobulinemia in the early post-operative period can impact post-surgical outcomes (i.e., infection, fluid overload, and associated morbidities).

Conditions

Hypogammaglobulinemia; Congenital Heart Disease

Keywords

congenital heart disease; Cardiopulmonary Bypass; Hypogammaglobulinemia

Outcome Measures

Primary Outcomes (4)

• Post-Operative Infections

  The primary endpoint of this study is incidence of post-operative infections through hospital discharge

  until Hospital Discharge, an average of 30 days

• Post-operative Infection

  Any positive culture or treatment for culture negative sepsis within 1 week of surgery

  within 1 week of surgery

• Blood Stream Infection

  Any positive blood culture during the post-operative period until hospital discharge

  until Hospital Discharge, an average of 30 days

• Blood Stream Infection Within 1 Week of Surgery

  7 days

Secondary Outcomes (22)

• Post-operative Plasma Albumin

  up to 48 hours post CPB

• Fluid Overload Variables

  0-24 hours post-CPB

• Post-operative Inotrope Score

  first 48 hours post-CPB

• Respiratory Variables

  until Hospital Discharge, an average of 30 days

• Hospital Discharge

  Approximately 1 month

Study Arms (2)

IVIG

EXPERIMENTAL

Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose and will be administered per hospital standards for IVIG administration.

Drug: IVIG

Normal Saline

PLACEBO COMPARATOR

Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug. This infusion will be administered as if the subject is receiving IVIG according to hospital policy.

Other: Placebo

Interventions

IVIG DRUG

Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care.

Also known as: Gamunex

IVIG

Placebo OTHER

If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight.

Also known as: Normal Saline

Normal Saline

Eligibility Criteria

• Age: Up to 6 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Infants \<6 months old
• Successfully weaned off cardiopulmonary bypass after cardiac surgery

You may not qualify if:

• Requirement of extra corporeal membrane oxygenation in the operating room
• Known immune deficiency
• Current Do Not Resuscitate or limitation of care order
• Current enrollment in another interventional clinical study
• Refusal of parental consent

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• Grifols Biologicals, LLC: collaborator

Study Sites (1)

Children's of Alabama

Birmingham, Alabama, 35233, United States

Location

MeSH Terms

Conditions

Agammaglobulinemia; Heart Defects, Congenital

Interventions

Immunoglobulins, Intravenous; Saline Solution

Condition Hierarchy (Ancestors)

Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Immunoglobulin G; Immunoglobulin Isotypes; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Jeffrey Alten, MD
• Organization: UAB Pediatric Cardiac Critical Care Medicine

jalten@peds.uab.edu

(205) 975-3123

Study Officials

• Jeffrey Alten, MD

  University of Alabama at Birmingham Pediatric Cardiac Critical Care

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 14, 2014
• First Posted: January 23, 2014
• Study Start: May 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: April 13, 2017
• Results First Posted: April 13, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)