Trial Outcomes & Findings for Post-bypass Prophylactic IVIG in Infants and Neonates (NCT NCT02043379)

NCT ID: NCT02043379

Last Updated: 2017-04-13

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 50 participants
• Primary outcome timeframe: until Hospital Discharge, an average of 30 days
• Results posted on: 2017-04-13

Participant Flow

Participant milestones

Measure	IVIG 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. IVIG: 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.	Normal Saline 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. Placebo: 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.
Overall Study STARTED	30	20
Overall Study COMPLETED	30	20
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Post-bypass Prophylactic IVIG in Infants and Neonates

Baseline characteristics by cohort

Measure	IVIG n=30 Participants 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. IVIG: 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.	Normal Saline n=20 Participants 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. Placebo: 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.	Total n=50 Participants Total of all reporting groups
Age, Categorical <=18 years	30 Participants n=5 Participants	20 Participants n=7 Participants	50 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	9 days n=5 Participants	47 days n=7 Participants	11.5 days n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants	8 Participants n=7 Participants	22 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants	12 Participants n=7 Participants	28 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	8 Participants n=5 Participants	2 Participants n=7 Participants	10 Participants n=5 Participants
Race (NIH/OMB) White	22 Participants n=5 Participants	18 Participants n=7 Participants	40 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Weight	3.45 kilograms n=5 Participants	3.85 kilograms n=7 Participants	3.51 kilograms n=5 Participants
Gestational Age	38 weeks n=5 Participants	38.5 weeks n=7 Participants	38 weeks n=5 Participants
STAT category 1	3 participants n=5 Participants	0 participants n=7 Participants	3 participants n=5 Participants
STAT category 2	2 participants n=5 Participants	5 participants n=7 Participants	7 participants n=5 Participants
STAT category 3	7 participants n=5 Participants	8 participants n=7 Participants	15 participants n=5 Participants
STAT category 4	12 participants n=5 Participants	4 participants n=7 Participants	16 participants n=5 Participants
STAT category 5	6 participants n=5 Participants	3 participants n=7 Participants	9 participants n=5 Participants
Cardiopulmonyar bypass time	105.5 minutes n=5 Participants	91.5 minutes n=7 Participants	97.5 minutes n=5 Participants
Aortic cross clamp time	52 minutes n=5 Participants	56 minutes n=7 Participants	53.5 minutes n=5 Participants
Intubated Pre-operatively Yes	5 subjects n=5 Participants	5 subjects n=7 Participants	10 subjects n=5 Participants
Intubated Pre-operatively No	25 subjects n=5 Participants	15 subjects n=7 Participants	40 subjects n=5 Participants

PRIMARY outcome

Timeframe: until Hospital Discharge, an average of 30 days

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

Outcome measures

Measure	IVIG n=30 Participants 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. IVIG: 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.	Normal Saline n=20 Participants 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. Placebo: 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.
Post-Operative Infections Yes	9 subjects	6 subjects
Post-Operative Infections No	21 subjects	14 subjects

PRIMARY outcome

Timeframe: within 1 week of surgery

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

Outcome measures

Measure	IVIG n=30 Participants 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. IVIG: 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.	Normal Saline n=20 Participants 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. Placebo: 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.
Post-operative Infection Yes	5 Subjects	3 Subjects
Post-operative Infection No	25 Subjects	17 Subjects

PRIMARY outcome

Timeframe: until Hospital Discharge, an average of 30 days

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

Outcome measures

Measure	IVIG n=30 Participants 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. IVIG: 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.	Normal Saline n=20 Participants 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. Placebo: 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.
Blood Stream Infection Yes	5 subjects	1 subjects
Blood Stream Infection No	25 subjects	19 subjects

PRIMARY outcome

Timeframe: 7 days

Outcome measures

Measure	IVIG n=30 Participants 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. IVIG: 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.	Normal Saline n=20 Participants 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. Placebo: 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.
Blood Stream Infection Within 1 Week of Surgery Yes	3 subjects	0 subjects
Blood Stream Infection Within 1 Week of Surgery No	27 subjects	20 subjects

SECONDARY outcome

Timeframe: up to 48 hours post CPB

Plasma albumin will be assessed at 24 and 48 hours.

Outcome measures

Measure	IVIG n=30 Participants 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. IVIG: 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.	Normal Saline n=20 Participants 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. Placebo: 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.
Post-operative Plasma Albumin 24 hour post-op	3.7 g/dL Standard Deviation 0.74	4.1 g/dL Standard Deviation 0.67
Post-operative Plasma Albumin 48 hour post-op	3.3 g/dL Standard Deviation 0.57	3.6 g/dL Standard Deviation 0.52

SECONDARY outcome

Timeframe: 0-24 hours post-CPB

The following fluid overload variables will be assessed in milliliters per kilogram at 0-24 hours post-cardiopulmonary bypass: blood product and albumin administration, chest tube output, urine output, peritoneal dialysis output, net fluid balance, and percent fluid overload. The total output the subject's produce (urine, chest tube, peritoneal drainage, etc.) will be subtracted from the total input (medications, blood products, albumin administration, etc) to determine the total fluid intake in milliliters. This total number will then be divided by the subject's weight in kilograms to determine the fluid overload in mL/kg.

Outcome measures

Measure	IVIG n=30 Participants 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. IVIG: 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.	Normal Saline n=20 Participants 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. Placebo: 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.
Fluid Overload Variables	30 mililiters/kilogram Interval 0.6 to 74.0	58.1 mililiters/kilogram Interval 34.4 to 87.0

SECONDARY outcome

Timeframe: first 48 hours post-CPB

The average admit, 12 hour, 24 hour, and 48 hour post-operative inotrope score will be calculated excluding Milrinone. To calculate the inotrope score the following formula was used: (Epinephrine/Norepinephrine dose in mcg/kg/min x 100) + (Dopamine dose in mcg/kg/min x 1) + (Phenylephrine dose in mcg/kg/min x 10) + (Vasopressin dose unit/kg/hr x 60/10000). The higher the inotrope score the more cardiac support the subject requires. There is not a "normal" scale or range used for this calculation.

Outcome measures

Measure	IVIG n=30 Participants 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. IVIG: 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.	Normal Saline n=20 Participants 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. Placebo: 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.
Post-operative Inotrope Score Admit	5 inotropic score Interval 3.23 to 7.95	4.5 inotropic score Interval 3.15 to 6.6
Post-operative Inotrope Score 12 hr post-op	5.3 inotropic score Interval 3.25 to 7.68	5.3 inotropic score Interval 3.0 to 8.0
Post-operative Inotrope Score 24 hr post-op	5.3 inotropic score Interval 3.3 to 7.3	5.8 inotropic score Interval 3.18 to 6.93
Post-operative Inotrope Score 48 hr post-op	6.8 inotropic score Interval 3.08 to 7.83	2 inotropic score Interval 1.0 to 6.25

SECONDARY outcome

Timeframe: until Hospital Discharge, an average of 30 days

Alive, ventilator free days will be recorded at hospital discharge.

Outcome measures

Measure	IVIG n=30 Participants 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. IVIG: 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.	Normal Saline n=20 Participants 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. Placebo: 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.
Respiratory Variables	24.7 days Interval 21.1 to 26.3	25.5 days Interval 21.6 to 27.0

SECONDARY outcome

Timeframe: Approximately 1 month

From admit post-operative to the Pediatric cardiac intensive care unit until discharge from the hospital in days.

Outcome measures

Measure	IVIG n=30 Participants 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. IVIG: 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.	Normal Saline n=20 Participants 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. Placebo: 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.
Hospital Discharge	22 days Interval 11.25 to 35.0	22 days Interval 7.25 to 34.75

SECONDARY outcome

Timeframe: 5 days post-op

Plasma Immunoglobulin levels will be checked pre-operatively, 12 hours post-op and 5 days post-op

Outcome measures

Measure	IVIG n=30 Participants 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. IVIG: 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.	Normal Saline n=20 Participants 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. Placebo: 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.
Plasma Immunoglobulins Pre-operative serum IgG level	487 mg/dL Standard Deviation 226.1	414 mg/dL Standard Deviation 230.5
Plasma Immunoglobulins 12 hour post-operative serum IgG level	496 mg/dL Standard Deviation 183	569 mg/dL Standard Deviation 272
Plasma Immunoglobulins Post-operative day 3 serum IgG level	837 mg/dL Standard Deviation 243	508 mg/dL Standard Deviation 215.4
Plasma Immunoglobulins Post-operative day 5 serum IgG level	839 mg/dL Standard Deviation 213	585 mg/dL Standard Deviation 212.3

SECONDARY outcome

Timeframe: Pre-operative to 48 hours post-operative

Plasma cytokine levels measured preoperatively, 0, 4, 12, 24 hours, and 48 hours post-operatively.

Outcome measures

Measure	IVIG n=30 Participants 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. IVIG: 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.	Normal Saline n=20 Participants 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. Placebo: 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.
Interferon-gamma Plasma Cytokine Levels Pre-operative	2.2 pg/mL Interval 0.7 to 4.5	3.5 pg/mL Interval 2.5 to 7.7
Interferon-gamma Plasma Cytokine Levels 0 hour post-op	2.6 pg/mL Interval 1.3 to 4.2	6 pg/mL Interval 3.4 to 12.4
Interferon-gamma Plasma Cytokine Levels 4 hour post-op	2.8 pg/mL Interval 2.2 to 4.1	6.1 pg/mL Interval 3.0 to 16.0
Interferon-gamma Plasma Cytokine Levels 12 hour post-op	2.8 pg/mL Interval 2.0 to 4.5	6.3 pg/mL Interval 2.6 to 10.4
Interferon-gamma Plasma Cytokine Levels 24 hour post-op	2 pg/mL Interval 1.3 to 3.2	5.6 pg/mL Interval 2.7 to 11.5
Interferon-gamma Plasma Cytokine Levels 48 hour post-op	2.2 pg/mL Interval 1.4 to 3.2	3.4 pg/mL Interval 2.3 to 5.2

SECONDARY outcome

Timeframe: 24 hours post-op

Immunoglobulin concentration will be measured from chest tube every 4 hours for first 12 hours post-operative and then 24 hours post-operative.

Outcome measures

Measure	IVIG n=30 Participants 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. IVIG: 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.	Normal Saline n=20 Participants 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. Placebo: 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.
Immunoglobulin Concentration in Chest Tube Drainage 0 hr post-op	50.9 mg/dL Interval 23.3 to 73.6	62.2 mg/dL Interval 39.4 to 117.5
Immunoglobulin Concentration in Chest Tube Drainage 4 hr post-op	154.3 mg/dL Interval 79.4 to 250.7	161.3 mg/dL Interval 111.0 to 291.2
Immunoglobulin Concentration in Chest Tube Drainage 8 hr post-op	195.2 mg/dL Interval 122.3 to 308.6	227.6 mg/dL Interval 150.6 to 448.1
Immunoglobulin Concentration in Chest Tube Drainage 12 hr post-op	233.5 mg/dL Interval 155.3 to 316.3	226.8 mg/dL Interval 202.4 to 447.2
Immunoglobulin Concentration in Chest Tube Drainage 24 hr post-op	614.2 mg/dL Interval 471.0 to 916.4	268.7 mg/dL Interval 190.1 to 578.0

SECONDARY outcome

Timeframe: Approximately 1 month

Incidence of mortality from admit to Pediatric cardiac intensive care unit post-operatively until hospital discharge .

Outcome measures

Measure	IVIG n=30 Participants 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. IVIG: 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.	Normal Saline n=20 Participants 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. Placebo: 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.
Mortality Yes	3 subjects	2 subjects
Mortality No	27 subjects	18 subjects

SECONDARY outcome

Timeframe: 1 month

The length of stay in the pediatric cardiac intensive care unit from admit post-operative until either discharge home, discharge to another unit/hospital/care facility, or death. This value is calculated in hours. Admit post-operative is recorded as hour 0.

Outcome measures

Measure	IVIG n=30 Participants 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. IVIG: 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.	Normal Saline n=20 Participants 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. Placebo: 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.
Intensive Care Unit Length of Stay	357.9 hours Interval 141.3 to 536.6	189.6 hours Interval 106.0 to 575.8

SECONDARY outcome

Timeframe: 0-48 hours post-CPB

The following fluid overload variables will be assessed at 0-24 hours, 25-48 hours, and 0-48 hours post-cardiopulmonary bypass: blood product and albumin administration, chest tube output, urine output, peritoneal dialysis output, net fluid balance, and percent fluid overload.The total output the subject's produce (urine, chest tube, peritoneal drainage, etc.) will be subtracted from the total input (medications, blood products, albumin administration, etc) to determine the total fluid intake in milliliters. This total number will then be divided by the subject's weight in kilograms to determine the fluid overload in mL/kg.

Outcome measures

Measure	IVIG n=30 Participants 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. IVIG: 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.	Normal Saline n=20 Participants 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. Placebo: 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.
Fluid Overload Variables 0-24 hours post-CPB	30 militers/kilogram Interval 0.6 to 74.0	58.1 militers/kilogram Interval 34.4 to 87.0
Fluid Overload Variables 25-48 hours post-CPB	7.4 militers/kilogram Interval -35.53 to 41.55	34.9 militers/kilogram Interval -0.4 to 43.85
Fluid Overload Variables 0-48 hours post-CPB	46.6 militers/kilogram Interval 13.9 to 85.25	77 militers/kilogram Interval 36.8 to 114.73

SECONDARY outcome

Timeframe: until extubation, an average of 2 days

Time until first extubation in hours

Outcome measures

Measure	IVIG n=30 Participants 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. IVIG: 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.	Normal Saline n=20 Participants 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. Placebo: 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.
Respiratory Variables	46 hours Interval 18.5 to 88.1	43 hours Interval 18.0 to 93.2

SECONDARY outcome

Timeframe: until extubation, an average of 2 days

Total time duration of post-operative length of mechanical ventilation until hospital discharge

Outcome measures

Measure	IVIG n=30 Participants 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. IVIG: 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.	Normal Saline n=20 Participants 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. Placebo: 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.
Respiratory Variables	62.1 hours Interval 29.9 to 165.0	59 hours Interval 23.3 to 153.5

SECONDARY outcome

Timeframe: pre-operative through 48 hours post-operative

Plasma cytokine levels measured preoperatively, 0, 4, 12, 24 hours, and 48 hours post-operatively.

Outcome measures

Measure	IVIG n=30 Participants 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. IVIG: 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.	Normal Saline n=20 Participants 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. Placebo: 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.
Interleukin-10 Plasma Cytokine Levels Pre-operative	1.4 pg/mL Interval 1.0 to 3.2	1.8 pg/mL Interval 1.1 to 3.0
Interleukin-10 Plasma Cytokine Levels 0 hour post-operative	54.4 pg/mL Interval 37.5 to 91.7	124 pg/mL Interval 52.5 to 216.5
Interleukin-10 Plasma Cytokine Levels 4 hour post-operative	10.1 pg/mL Interval 6.4 to 25.3	20.1 pg/mL Interval 7.9 to 56.7
Interleukin-10 Plasma Cytokine Levels 12 hour post-operative	4.7 pg/mL Interval 2.7 to 7.9	10.2 pg/mL Interval 5.5 to 20.9
Interleukin-10 Plasma Cytokine Levels 24 hour post-operative	1.8 pg/mL Interval 1.2 to 3.6	4 pg/mL Interval 2.0 to 6.7
Interleukin-10 Plasma Cytokine Levels 48 hour post-operatiave	1.1 pg/mL Interval 0.8 to 2.3	2.3 pg/mL Interval 1.2 to 9.8

SECONDARY outcome

Timeframe: pre-operative through 48 hours post-operative

Plasma cytokine levels measured preoperatively, 0, 4, 12, 24 hours, and 48 hours post-operatively.

Outcome measures

Measure	IVIG n=30 Participants 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. IVIG: 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.	Normal Saline n=20 Participants 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. Placebo: 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.
Interleukin-12p70 Plasma Cytokine Levels Pre-operative	0.2 pg/mL Interval 0.2 to 0.2	0.2 pg/mL Interval 0.2 to 0.6
Interleukin-12p70 Plasma Cytokine Levels 0 hour post-operative	0.2 pg/mL Interval 0.2 to 0.3	0.6 pg/mL Interval 0.3 to 2.1
Interleukin-12p70 Plasma Cytokine Levels 4 hour post-operative	0.4 pg/mL Interval 0.3 to 0.5	0.5 pg/mL Interval 0.3 to 3.5
Interleukin-12p70 Plasma Cytokine Levels 12 hour post-operative	0.5 pg/mL Interval 0.3 to 0.8	1 pg/mL Interval 0.4 to 2.0
Interleukin-12p70 Plasma Cytokine Levels 24 hour post-operative	0.3 pg/mL Interval 0.2 to 0.5	0.7 pg/mL Interval 0.3 to 1.6
Interleukin-12p70 Plasma Cytokine Levels 48 hour post-operatiave	0.2 pg/mL Interval 0.2 to 0.3	0.4 pg/mL Interval 0.2 to 0.8

SECONDARY outcome

Timeframe: pre-operative through 48 hours post-operative

Plasma cytokine levels measured preoperatively, 0, 4, 12, 24 hours, and 48 hours post-operatively.

Outcome measures

Measure	IVIG n=30 Participants 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. IVIG: 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.	Normal Saline n=20 Participants 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. Placebo: 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.
Interleukin-1b Plasma Cytokine Levels Pre-operative	0.2 pg/mL Interval 0.1 to 0.2	0.2 pg/mL Interval 0.1 to 0.7
Interleukin-1b Plasma Cytokine Levels 0 hour post-operative	0.3 pg/mL Interval 0.2 to 0.4	0.4 pg/mL Interval 0.3 to 0.4
Interleukin-1b Plasma Cytokine Levels 4 hour post-operative	0.3 pg/mL Interval 0.3 to 0.6	0.5 pg/mL Interval 0.4 to 0.6
Interleukin-1b Plasma Cytokine Levels 12 hour post-operative	0.3 pg/mL Interval 0.3 to 0.5	0.3 pg/mL Interval 0.2 to 0.3
Interleukin-1b Plasma Cytokine Levels 24 hour post-operative	0.3 pg/mL Interval 0.2 to 0.5	0.5 pg/mL Interval 0.3 to 1.4
Interleukin-1b Plasma Cytokine Levels 48 hour post-operatiave	0.3 pg/mL Interval 0.2 to 0.6	0.3 pg/mL Interval 0.2 to 0.4

SECONDARY outcome

Timeframe: pre-operative through 48 hours post-operative

Plasma cytokine levels measured preoperatively, 0, 4, 12, 24 hours, and 48 hours post-operatively.

Outcome measures

Measure	IVIG n=30 Participants 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. IVIG: 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.	Normal Saline n=20 Participants 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. Placebo: 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.
Interleukin-6 Plasma Cytokine Levels Pre-operative	2.1 pg/mL Interval 1.1 to 5.5	3.3 pg/mL Interval 1.4 to 7.6
Interleukin-6 Plasma Cytokine Levels 0 hour post-operative	10.3 pg/mL Interval 6.6 to 16.2	17.3 pg/mL Interval 9.9 to 30.7
Interleukin-6 Plasma Cytokine Levels 4 hour post-operative	32.6 pg/mL Interval 23.6 to 46.5	52.4 pg/mL Interval 33.8 to 84.9
Interleukin-6 Plasma Cytokine Levels 12 hour post-operative	43.6 pg/mL Interval 29.6 to 64.8	49.8 pg/mL Interval 36.6 to 86.6
Interleukin-6 Plasma Cytokine Levels 24 hour post-operative	26.3 pg/mL Interval 15.6 to 50.4	40.8 pg/mL Interval 24.2 to 81.3
Interleukin-6 Plasma Cytokine Levels 48 hour post-operatiave	15.8 pg/mL Interval 9.4 to 21.5	15.5 pg/mL Interval 10.5 to 24.8

SECONDARY outcome

Timeframe: pre-operative through 48 hours post-operative

Plasma cytokine levels measured preoperatively, 0, 4, 12, 24 hours, and 48 hours post-operatively.

Outcome measures

Measure	IVIG n=30 Participants 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. IVIG: 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.	Normal Saline n=20 Participants 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. Placebo: 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.
Interleukin-8 Plasma Cytokine Levels Pre-operative	18.7 pg/dL Interval 14.4 to 22.7	17.7 pg/dL Interval 12.8 to 23.4
Interleukin-8 Plasma Cytokine Levels 0 hour post-operative	76.5 pg/dL Interval 58.8 to 131.0	163 pg/dL Interval 99.9 to 255.5
Interleukin-8 Plasma Cytokine Levels 4 hour post-operative	116.5 pg/dL Interval 63.6 to 162.3	147.5 pg/dL Interval 71.0 to 214.8
Interleukin-8 Plasma Cytokine Levels 12 hour post-operative	67.1 pg/dL Interval 36.7 to 131.0	90 pg/dL Interval 50.0 to 132.0
Interleukin-8 Plasma Cytokine Levels 24 hour post-operative	47.7 pg/dL Interval 40.3 to 61.7	46 pg/dL Interval 33.4 to 112.8
Interleukin-8 Plasma Cytokine Levels 48 hour post-operatiave	33.6 pg/dL Interval 24.6 to 59.8	38.2 pg/dL Interval 23.6 to 64.7

SECONDARY outcome

Timeframe: pre-operative through 48 hours post-operative

Plasma cytokine levels measured preoperatively, 0, 4, 12, 24 hours, and 48 hours post-operatively.

Outcome measures

Measure	IVIG n=30 Participants 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. IVIG: 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.	Normal Saline n=20 Participants 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. Placebo: 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.
Tumor Necrosis Factor Plasma Cytokine Levels Pre-operative	2.3 pg/dL Interval 1.9 to 3.4	2.9 pg/dL Interval 2.4 to 4.0
Tumor Necrosis Factor Plasma Cytokine Levels 0 hour post-operative	2.9 pg/dL Interval 2.2 to 3.8	4.3 pg/dL Interval 2.5 to 6.4
Tumor Necrosis Factor Plasma Cytokine Levels 4 hour post-operative	3.7 pg/dL Interval 2.6 to 5.6	5.3 pg/dL Interval 3.7 to 7.6
Tumor Necrosis Factor Plasma Cytokine Levels 12 hour post-operative	3.1 pg/dL Interval 2.2 to 3.4	4.1 pg/dL Interval 2.7 to 5.5
Tumor Necrosis Factor Plasma Cytokine Levels 24 hour post-operative	2.9 pg/dL Interval 2.2 to 3.4	3.8 pg/dL Interval 3.0 to 5.0
Tumor Necrosis Factor Plasma Cytokine Levels 48 hour post-operatiave	2.4 pg/dL Interval 2.0 to 3.2	3.5 pg/dL Interval 2.1 to 4.8

SECONDARY outcome

Timeframe: 24 hours post-op

Immunoglobulin concentration will be measured from chest tube and peritoneal drain every 4 hours for first 12 hours post-operative and 24 hours post-operative.

Outcome measures

Measure	IVIG n=30 Participants 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. IVIG: 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.	Normal Saline n=20 Participants 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. Placebo: 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.
Immunoglobulin Concentration in Peritoneal Dialysis Drainage 0 hr post-op	33.1 mg/dL Interval 18.8 to 52.1	101.6 mg/dL Interval 11.5 to 144.3
Immunoglobulin Concentration in Peritoneal Dialysis Drainage 4 hr post-op	136.2 mg/dL Interval 45.6 to 263.3	201.6 mg/dL Interval 114.5 to 384.2
Immunoglobulin Concentration in Peritoneal Dialysis Drainage 8 hr post-op	279.8 mg/dL Interval 193.4 to 446.8	221.2 mg/dL Interval 84.4 to 513.2
Immunoglobulin Concentration in Peritoneal Dialysis Drainage 12 hr post-op	387.33 mg/dL Interval 143.1 to 510.2	300.1 mg/dL Interval 149.4 to 434.3
Immunoglobulin Concentration in Peritoneal Dialysis Drainage 24 hr post-op	1613.9 mg/dL Interval 598.3 to 2181.1	366.9 mg/dL Interval 170.4 to 984.2

SECONDARY outcome

Timeframe: 48 hours

Pre-operative and 48 hour post-operative maximum creatinine recorded.

Outcome measures

Measure	IVIG n=30 Participants 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. IVIG: 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.	Normal Saline n=20 Participants 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. Placebo: 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.
Serum Creatinine Pre-operative	0.4 mg/dL Standard Deviation 0.15	0.4 mg/dL Standard Deviation 0.17
Serum Creatinine Max	0.8 mg/dL Standard Deviation 0.28	0.7 mg/dL Standard Deviation 0.38

SECONDARY outcome

Timeframe: pre-operative through 24 hours post-operative

Outcome measures

Measure	IVIG n=30 Participants 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. IVIG: 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.	Normal Saline n=20 Participants 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. Placebo: 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.
Lactic Acid Pre-operative	1.3 mmol/L Standard Deviation 0.65	1.4 mmol/L Standard Deviation 0.75
Lactic Acid 24 hour maximum	5.7 mmol/L Standard Deviation 4	5.4 mmol/L Standard Deviation 4.54

Adverse Events

IVIG

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Normal Saline

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jeffrey Alten, MD

UAB Pediatric Cardiac Critical Care Medicine

Phone: (205) 975-3123

Email: jalten@peds.uab.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place