N/A N=50 Randomized Triple-blind Treatment

Post-bypass Prophylactic IVIG in Infants and Neonates

Hypogammaglobulinemia · Congenital Heart Disease

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View on ClinicalTrials.gov: NCT02043379 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2017

Primary outcome: Primary: Post-Operative Infections — 9; 6; 21; 14 subjects — p=1

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: IVIG (Drug); Placebo (Other)
Age: Pediatric
Sex: All
Sponsor: University of Alabama at Birmingham
Primary completion: Jun 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Post-Operative Infections	9; 6; 21; 14	1
PRIMARY Post-operative Infection	5; 3; 25; 17	1
PRIMARY Blood Stream Infection	5; 1; 25; 19	0.38
PRIMARY Blood Stream Infection Within 1 Week of Surgery	3; 0; 27; 20	0.26
SECONDARY Post-operative Plasma Albumin	3.7; 4.1; 3.3; 3.6	0.42
SECONDARY Fluid Overload Variables	30; 58.1; 7.4; 34.9; 46.6; 77	0.09
SECONDARY Post-operative Inotrope Score	5; 4.5; 5.3; 5.3; 5.3; 5.8	0.81
SECONDARY Respiratory Variables	62.1; 59	0.63
SECONDARY Hospital Discharge	22; 22	0.79
SECONDARY Plasma Immunoglobulins	487; 414; 496; 569; 837; 508	0.32
SECONDARY Interferon-gamma Plasma Cytokine Levels	2.2; 3.5; 2.6; 6; 2.8; 6.1	0.60
SECONDARY Immunoglobulin Concentration in Chest Tube Drainage	50.9; 62.2; 154.3; 161.3; 195.2; 227.6	0.27
SECONDARY Mortality	3; 2; 27; 18	1
SECONDARY Intensive Care Unit Length of Stay	357.9; 189.6	0.4
SECONDARY Fluid Overload Variables	30; 58.1; 7.4; 34.9; 46.6; 77	0.09
SECONDARY Respiratory Variables	62.1; 59	0.63
SECONDARY Respiratory Variables	62.1; 59	0.63
SECONDARY Interleukin-10 Plasma Cytokine Levels	1.4; 1.8; 54.4; 124; 10.1; 20.1	0.41
SECONDARY Interleukin-12p70 Plasma Cytokine Levels	0.2; 0.2; 0.2; 0.6; 0.4; 0.5	0.28
SECONDARY Interleukin-1b Plasma Cytokine Levels	0.2; 0.2; 0.3; 0.4; 0.3; 0.5	0.1
SECONDARY Interleukin-6 Plasma Cytokine Levels	2.1; 3.3; 10.3; 17.3; 32.6; 52.4	0.35
SECONDARY Interleukin-8 Plasma Cytokine Levels	18.7; 17.7; 76.5; 163; 116.5; 147.5	0.1
SECONDARY Tumor Necrosis Factor Plasma Cytokine Levels	2.3; 2.9; 2.9; 4.3; 3.7; 5.3	0.46
SECONDARY Immunoglobulin Concentration in Peritoneal Dialysis Drainage	33.1; 101.6; 136.2; 201.6; 279.8; 221.2	0.37
SECONDARY Serum Creatinine	0.4; 0.4; 0.8; 0.7	0.43
SECONDARY Lactic Acid	1.3; 1.4; 5.7; 5.4	0.87

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).

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

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Data sourced from ClinicalTrials.gov (NCT02043379). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.