Back to resultsL-citrulline for Prevention of Sequelae of Acute Lung Injury in Pediatrics Undergoing Cardiopulmonary Bypass for Heart Defects
Primary Purpose
Acute Lung Injury
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
L-citrulline
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Acute Lung Injury focused on measuring L-citrulline, pediatric, Lung Injury, Bypass, Heart Defects, Clinical Sequelae
Eligibility Criteria
Inclusion Criteria:
- Subjects, parents, or legal guardian of the subject who are willing and able to sign informed consent
- Male and female subjects aged ≤18 years of age
- Infants, children and adolescents undergoing CPB for repair of a large unrestrictive VSD, an ostium primum ASD, or a partial or complete AVSD
- Pre-operative echocardiogram which confirms the cardiovascular anatomy and defect to be surgically repaired
Exclusion Criteria:
Evidence of pulmonary artery or vein abnormalities on the pre-operative echocardiogram that will not be addressed surgically. Specific abnormalities excluded include the following:
- Significant pulmonary artery narrowing not amenable to surgical correction
- Previous pulmonary artery stent placement
- Significant left sided AV valve regurgitation not amenable to surgical correction
- Pulmonary venous return abnormalities not amenable to surgical correction
- Pulmonary vein stenosis not amenable to surgical correction
- Preoperative requirement for mechanical ventilation or intravenous inotrope support
- Presence of fixed or idiopathic pulmonary hypertension (i.e. Eisenmenger's Syndrome) prior to surgical repair
- Pre-operative use of medications to treat pulmonary hypertension
- Pregnancy; Females of child-bearing potential must be willing to participate an acceptable method of birth control for the duration of study participation (e.g. oral contraceptive, hormonal implant, intra-uterine device)
- Any condition which, in the opinion of the investigator, might interfere with the study objectives
- Participation in another clinical trial within 30 days of Screening or while participating in the current study, including the 28 days of follow-up post study drug administration
Sites / Locations
- University of Alabama
- Loma Linda University Children's Hospital
- University of California Davis Medical Center
- Children's Hospital Colorado
- Children's National Medical Center
- Nicklaus Children's Hospital
- Arnold Palmer Hospital for Children
- Advocate Children's Hospital
- Riley Hospital for Children at Indiana University
- The Johns Hopkins Hospital
- University of Mississippi Medical Center
- St Louis University, SSM Health Cardinal Glennon Children's Hospital
- Washington University School of Medicine/ St Louis Children's Hospital
- The Children's Hospital at Montefiore
- Columbia University Medical Center
- Cincinnati Children's Hospital Medical Center
- Nationwide Children's Hospital
- Primary Children's Hospital
- Seattle Children's Hospital
- University of Wisconsin
- LKH-Universitätsklinikum Graz Universitätsklinik für Kinder- und Jugendheilkunde
- Medizinische Universität Wien, Klinik für Kinder- und Jugendheilkunde, Abteilung für Pädiatrische Kardiologie Kinderherzzentrum
- Universitätsmedizin Göttingen
- Medizinische Hochschule Hannover
- Klinik für Kinderkardiologie und angeborene Herzfehler. Deutsches Herzzentrum München - Klinik an der TU München
- Universitätsklinik Tübingen, Kinderkardiologie Pulmonologie, Intensivmedizin
- Rambam Health Care Center
- Wolfson Medical Center
- Sheba Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
L-citrulline
Placebo
Arm Description
Bolus of 150 mg/kg at the initiation of cardiopulmonary bypass, but after removal of any crystalloid base; Addition of study medication at a concentration of 200 μmol/L given as a bolus during bypass. This may be administered as a one-time bolus or multiple administrations to compensate for fluids containing L-citrulline that may be removed from the patient during the course of the operation and thus to maintain the concentration of 200 μmol/L; Bolus of 20 mg/kg 30 minutes after decannulation from cardiopulmonary bypass; 9 mg/kg/hr continuous infusion for up to 48 hours.
Bolus of 150 mg/kg at the initiation of cardiopulmonary bypass; Addition of placebo matched for volume given as a bolus during bypass. This may be administered as a one-time bolus or multiple administrations during bypass; Bolus of 20 mg/kg 30 minutes after decannulation from cardiopulmonary bypass; 9 mg/kg/hr continuous infusion for up to 48 hours.
Outcomes
Primary Outcome Measures
A Composite Variable Consisting of the Longer of Either (1) Length of Time on Mechanical Ventilation or (2) Length of Inotrope Use.
Mechanical ventilation (MV) = invasive or noninvasive MV incl. bilevel (biphasic) positive airway pressure or continuous positive airway pressure. Inotrope use = medications considered within the derivation of total inotrope score (dopamine, dobutamine, milrinone, epinephrine, phenylephrine, norepinephrine). Both measures recorded until earliest of subject hospital discharge or Day 28.
Secondary Outcome Measures
Length of Time on Mechanical Ventilation
The same definitions and analyses as described for the primary endpoint will be applied.
Length of Time on Positive Pressure Ventilation
The same definitions and analyses as described for the primary endpoint will be applied.
Length of Time of Inotrope Use
The same definitions and analyses as described for the primary endpoint will be applied.
Inotrope Score
Inotrope score is reflective of the pharmacological support required by the cardiovascular system and is a good predictor of mortality and morbidity in patients undergoing bypass surgery. A lower inotrope score represents less pharmacological support and would indicate a lower risk for a poor clinical outcome. Therefore, any treatment effect would be indicated by a lower inotrope score in the citrulline group when compared to the placebo group.
In this study, the score was calculated each hour post-operatively from the time of separation from bypass until the completion of study drug. Additionally, the total inotrope score over time until Day 28 or hospital discharge was derived. Inotrope score was calculated using the following formula:
Total inotrope score = Dopamine dose (µg/kg/min) + Dobutamine dose (µg/kg/min) + 10 * Milrinone dose (µg/kg/min) + 100 * Epinephrine dose (µg/kg/min) + 100 * Phenylephrine dose (µg/kg/min) + 100 * Norepinephrine dose (µg/kg/min).
Hemodynamic Improvement: Heart Rate
Heart rate at hours 1, 2, 4, 12, 24 and 48.
Hemodynamic Improvement: Systemic Arterial Blood Pressure
Systemic arterial blood pressure at hours 1, 2, 4, 12, 24 and 48.
Hemodynamic Improvement: Oxygen Saturation
Oxygen saturation at hours 1, 2, 4, 12, 24 and 48.
Hemodynamic Improvement: Central Venous Pressure
Central venous pressure at hours 1, 2, 4, 12, 24 and 48.
Thoracotomy Output
The thoracotomy output is defined as the total volume of chest tube drainage recorded in cc prior to discontinuation of chest intubation. The total postoperative duration (in hours) that the chest tube is used will be calculated as the time from the end of the surgery to the time the chest tube is removed. If an additional chest tube is required or reinserted (until discharge from the hospital or at Day 28) the duration that the additional chest tube was used (from time of insertion to time of removal) will be added to the time the original chest tube was used for the total postoperative duration. If a subject did not use any chest tube the duration is set to 0. As a sensitivity analysis, subjects with no use of chest tube will be excluded. For subjects who died before discharge from the hospital or before Day 28, respectively, the observed duration of chest tube drainage will be used.
Length of Time of Intubation
The length will be derived as the time in hours from separation from CPB until discontinuation of intubation. Any duration of re-use of intubation will continue to accrue. If a subject did not use any intubation the length is set to 0. As a sensitivity analysis, subjects with no use of intubations will be excluded. For subjects who died before discharge from the hospital or before Day 28, respectively, the observed length of time on intubation will be used. As sensitivity analyses subjects who died will (1) be excluded from analysis and (2) be assigned a length of time on intubation of 28 days.
For the length of time on intubation the same analyses as described for the primary endpoint will be applied.
Length of Pediatric Intensive Care Unit (PICU) Stay
The length of PICU stay will be calculated as the total number of days postoperative until discharge from PICU. For subjects who died before discharge from PICU or before Day 28, respectively, the observed length of PICU stay will be used. As sensitivity analyses subjects who died will (1) be excluded from analysis and (2) be assigned a length of PICU stay of 28 days. For the length of PICU stay the same analyses as described for the primary endpoint will be applied.
Length of Time on Vasodilators
Length of time on vasodilators will be measured from first use following separation from bypass, until the subject is discharged from the hospital or at Day 28. The length will be derived as the time in hours from separation from CPB until discontinuation of all vasodilators.
Length of Hospitalization
The length of hospitalization will be calculated as the total number of days postoperative until discharge from the hospital. For subjects who died before discharge from the hospital or before Day 28, respectively, the observed length of hospitalization will be used. As sensitivity analyses subjects who died will (1) be excluded from analysis and (2) be assigned a length of hospitalization of 28 days. The same analyses as described for the primary endpoint will be applied.
Patients With Plasma Concentrations of Citrulline
Plasma citrulline concentrations will be assessed in both treatment groups to determine the number of patients who reach the therapeutic sustained target plasma citrulline level of ≥100 μmol/L. Blood collection for assessment of plasma citrulline concentrations will be taken prior to surgery, during surgery, 30 minutes post-decannulation after CPB (prior to bolus and 5 minutes after bolus), at the specified post-operative time points (6h, 12h, 24h, 48h), and at hospital discharge or Day 28, whichever occurs first.
Occurrence of Adverse and Serious Adverse Events
Pre-treatment adverse events and treatment adverse events will be analyzed separately. The number of affected subjects will be reported.
Number of Patients With Refractory Hypotension
Refractory hypotension is defined as a 20% drop of mean arterial pressure (MAP) below specific age-related criteria for more than 30 minutes. The number of subjects with any refractory hypotension from end of surgery until 48 hours will be compared between groups.
Full Information
NCT ID
NCT02891837
First Posted
August 23, 2016
Last Updated
January 27, 2023
Sponsor
Asklepion Pharmaceuticals, LLC
1. Study Identification
Unique Protocol Identification Number
NCT02891837
Brief Title
L-citrulline for Prevention of Sequelae of Acute Lung Injury in Pediatrics Undergoing Cardiopulmonary Bypass for Heart Defects
Official Title
A Phase III Double-Blind, Randomized, Placebo Controlled, Multi-Center Clinical Study to Evaluate the Efficacy and Safety of Intravenous L-citrulline for the Prevention of Clinical Sequelae of Acute Lung Injury Induced by Cardiopulmonary Bypass in Pediatric Subjects Undergoing Surgery for Congenital Heart Defects
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
August 2016 (Actual)
Primary Completion Date
June 2019 (Actual)
Study Completion Date
July 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Asklepion Pharmaceuticals, LLC
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to determine whether L-citrulline is effective and safe in the prevention of clinical sequelae of Acute Lung Injury in pediatric subjects undergoing surgery for congenital heart defects.
Detailed Description
This is a randomized, double-blind, placebo controlled, multicenter study that will compare the efficacy and safety of L-citrulline versus placebo in subjects undergoing surgery for congenital heart defects.
Eligible subjects undergoing repair of a large unrestrictive ventricular septal defect (VSD), a partial or complete atrioventricular septal defect (AVSD), or an ostium primum atrial septal defect (primum ASD) will be eligible for enrollment in this study.
Each enrolled subject will be randomized to receive either L-citrulline or placebo throughout all administrations in the study. Subjects will receive an L-citrulline bolus of 150 mg/kg or placebo at the initiation of cardiopulmonary bypass, the addition of L-citrulline at a concentration of 200 μmol/L or placebo given as a bolus during bypass. This may be administered as a one-time bolus or multiple administrations to compensate for fluids containing L-citrulline that may be removed from the patient during the course of the operation and thus to maintain the concentration of 200 μmol/L. L-citrulline bolus of 20 mg/kg or placebo 30 minutes after decannulation from cardiopulmonary bypass, followed immediately by a 9 mg/kg/hr continuous L-citrulline infusion or placebo for up to 48 hours.
The study drug or placebo infusion will be discontinued once invasive arterial blood pressure monitoring is discontinued or at 48 hours, whichever comes first. Subjects will be followed until Day 28 or discharge from the hospital, whichever comes first. For subjects discharged prior to Day 28, a final assessment via telephone will be conducted at Day 28.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Lung Injury
Keywords
L-citrulline, pediatric, Lung Injury, Bypass, Heart Defects, Clinical Sequelae
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
189 (Actual)
8. Arms, Groups, and Interventions
Arm Title
L-citrulline
Arm Type
Experimental
Arm Description
Bolus of 150 mg/kg at the initiation of cardiopulmonary bypass, but after removal of any crystalloid base;
Addition of study medication at a concentration of 200 μmol/L given as a bolus during bypass. This may be administered as a one-time bolus or multiple administrations to compensate for fluids containing L-citrulline that may be removed from the patient during the course of the operation and thus to maintain the concentration of 200 μmol/L;
Bolus of 20 mg/kg 30 minutes after decannulation from cardiopulmonary bypass;
9 mg/kg/hr continuous infusion for up to 48 hours.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Bolus of 150 mg/kg at the initiation of cardiopulmonary bypass;
Addition of placebo matched for volume given as a bolus during bypass. This may be administered as a one-time bolus or multiple administrations during bypass;
Bolus of 20 mg/kg 30 minutes after decannulation from cardiopulmonary bypass;
9 mg/kg/hr continuous infusion for up to 48 hours.
Intervention Type
Drug
Intervention Name(s)
L-citrulline
Intervention Description
Bolus of 150 mg/kg at the initiation of cardiopulmonary bypass, but after removal of any crystalloid base;
Addition of study medication at a concentration of 200 μmol/L given as a bolus during bypass. This may be administered as a one-time bolus or multiple administrations to compensate for fluids containing L-citrulline that may be removed from the patient during the course of the operation and thus to maintain the concentration of 200 μmol/L;
Bolus of 20 mg/kg 30 minutes after decannulation from cardiopulmonary bypass;
9 mg/kg/hr continuous infusion for up to 48 hours.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Bolus of 150 mg/kg at the initiation of cardiopulmonary bypass;
Addition of placebo matched for volume given as a bolus during bypass. This may be administered as a one-time bolus or multiple administrations during bypass;
Bolus of 20 mg/kg 30 minutes after decannulation from cardiopulmonary bypass;
9 mg/kg/hr continuous infusion for up to 48 hours.
Primary Outcome Measure Information:
Title
A Composite Variable Consisting of the Longer of Either (1) Length of Time on Mechanical Ventilation or (2) Length of Inotrope Use.
Description
Mechanical ventilation (MV) = invasive or noninvasive MV incl. bilevel (biphasic) positive airway pressure or continuous positive airway pressure. Inotrope use = medications considered within the derivation of total inotrope score (dopamine, dobutamine, milrinone, epinephrine, phenylephrine, norepinephrine). Both measures recorded until earliest of subject hospital discharge or Day 28.
Time Frame
28 Days
Secondary Outcome Measure Information:
Title
Length of Time on Mechanical Ventilation
Description
The same definitions and analyses as described for the primary endpoint will be applied.
Time Frame
28 Days
Title
Length of Time on Positive Pressure Ventilation
Description
The same definitions and analyses as described for the primary endpoint will be applied.
Time Frame
28 Days
Title
Length of Time of Inotrope Use
Description
The same definitions and analyses as described for the primary endpoint will be applied.
Time Frame
28 days
Title
Inotrope Score
Description
Inotrope score is reflective of the pharmacological support required by the cardiovascular system and is a good predictor of mortality and morbidity in patients undergoing bypass surgery. A lower inotrope score represents less pharmacological support and would indicate a lower risk for a poor clinical outcome. Therefore, any treatment effect would be indicated by a lower inotrope score in the citrulline group when compared to the placebo group.
In this study, the score was calculated each hour post-operatively from the time of separation from bypass until the completion of study drug. Additionally, the total inotrope score over time until Day 28 or hospital discharge was derived. Inotrope score was calculated using the following formula:
Total inotrope score = Dopamine dose (µg/kg/min) + Dobutamine dose (µg/kg/min) + 10 * Milrinone dose (µg/kg/min) + 100 * Epinephrine dose (µg/kg/min) + 100 * Phenylephrine dose (µg/kg/min) + 100 * Norepinephrine dose (µg/kg/min).
Time Frame
Up to 48 hours after separation from CBP
Title
Hemodynamic Improvement: Heart Rate
Description
Heart rate at hours 1, 2, 4, 12, 24 and 48.
Time Frame
2 Days
Title
Hemodynamic Improvement: Systemic Arterial Blood Pressure
Description
Systemic arterial blood pressure at hours 1, 2, 4, 12, 24 and 48.
Time Frame
2 Days
Title
Hemodynamic Improvement: Oxygen Saturation
Description
Oxygen saturation at hours 1, 2, 4, 12, 24 and 48.
Time Frame
2 Days
Title
Hemodynamic Improvement: Central Venous Pressure
Description
Central venous pressure at hours 1, 2, 4, 12, 24 and 48.
Time Frame
2 Days
Title
Thoracotomy Output
Description
The thoracotomy output is defined as the total volume of chest tube drainage recorded in cc prior to discontinuation of chest intubation. The total postoperative duration (in hours) that the chest tube is used will be calculated as the time from the end of the surgery to the time the chest tube is removed. If an additional chest tube is required or reinserted (until discharge from the hospital or at Day 28) the duration that the additional chest tube was used (from time of insertion to time of removal) will be added to the time the original chest tube was used for the total postoperative duration. If a subject did not use any chest tube the duration is set to 0. As a sensitivity analysis, subjects with no use of chest tube will be excluded. For subjects who died before discharge from the hospital or before Day 28, respectively, the observed duration of chest tube drainage will be used.
Time Frame
28 Days
Title
Length of Time of Intubation
Description
The length will be derived as the time in hours from separation from CPB until discontinuation of intubation. Any duration of re-use of intubation will continue to accrue. If a subject did not use any intubation the length is set to 0. As a sensitivity analysis, subjects with no use of intubations will be excluded. For subjects who died before discharge from the hospital or before Day 28, respectively, the observed length of time on intubation will be used. As sensitivity analyses subjects who died will (1) be excluded from analysis and (2) be assigned a length of time on intubation of 28 days.
For the length of time on intubation the same analyses as described for the primary endpoint will be applied.
Time Frame
28 Days
Title
Length of Pediatric Intensive Care Unit (PICU) Stay
Description
The length of PICU stay will be calculated as the total number of days postoperative until discharge from PICU. For subjects who died before discharge from PICU or before Day 28, respectively, the observed length of PICU stay will be used. As sensitivity analyses subjects who died will (1) be excluded from analysis and (2) be assigned a length of PICU stay of 28 days. For the length of PICU stay the same analyses as described for the primary endpoint will be applied.
Time Frame
28 Days
Title
Length of Time on Vasodilators
Description
Length of time on vasodilators will be measured from first use following separation from bypass, until the subject is discharged from the hospital or at Day 28. The length will be derived as the time in hours from separation from CPB until discontinuation of all vasodilators.
Time Frame
28 Days
Title
Length of Hospitalization
Description
The length of hospitalization will be calculated as the total number of days postoperative until discharge from the hospital. For subjects who died before discharge from the hospital or before Day 28, respectively, the observed length of hospitalization will be used. As sensitivity analyses subjects who died will (1) be excluded from analysis and (2) be assigned a length of hospitalization of 28 days. The same analyses as described for the primary endpoint will be applied.
Time Frame
28 Days
Title
Patients With Plasma Concentrations of Citrulline
Description
Plasma citrulline concentrations will be assessed in both treatment groups to determine the number of patients who reach the therapeutic sustained target plasma citrulline level of ≥100 μmol/L. Blood collection for assessment of plasma citrulline concentrations will be taken prior to surgery, during surgery, 30 minutes post-decannulation after CPB (prior to bolus and 5 minutes after bolus), at the specified post-operative time points (6h, 12h, 24h, 48h), and at hospital discharge or Day 28, whichever occurs first.
Time Frame
28 Days
Title
Occurrence of Adverse and Serious Adverse Events
Description
Pre-treatment adverse events and treatment adverse events will be analyzed separately. The number of affected subjects will be reported.
Time Frame
28 Days
Title
Number of Patients With Refractory Hypotension
Description
Refractory hypotension is defined as a 20% drop of mean arterial pressure (MAP) below specific age-related criteria for more than 30 minutes. The number of subjects with any refractory hypotension from end of surgery until 48 hours will be compared between groups.
Time Frame
2 Days
10. Eligibility
Sex
All
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects, parents, or legal guardian of the subject who are willing and able to sign informed consent
Male and female subjects aged ≤18 years of age
Infants, children and adolescents undergoing cardiopulmonary bypass (CPB) for repair of a large unrestrictive VSD, an ostium primum ASD, or a partial or complete AVSD
Pre-operative echocardiogram which confirms the cardiovascular anatomy and defect to be surgically repaired
Exclusion Criteria:
Evidence of pulmonary artery or vein abnormalities on the pre-operative echocardiogram that will not be addressed surgically. Specific abnormalities excluded include the following:
Significant pulmonary artery narrowing not amenable to surgical correction
Previous pulmonary artery stent placement
Significant left sided AV valve regurgitation not amenable to surgical correction
Pulmonary venous return abnormalities not amenable to surgical correction
Pulmonary vein stenosis not amenable to surgical correction
Preoperative requirement for mechanical ventilation or intravenous inotrope support
Presence of fixed or idiopathic pulmonary hypertension (i.e. Eisenmenger's Syndrome) prior to surgical repair
Pre-operative use of medications to treat pulmonary hypertension
Pregnancy; Females of child-bearing potential must be willing to participate an acceptable method of birth control for the duration of study participation (e.g. oral contraceptive, hormonal implant, intra-uterine device)
Any condition which, in the opinion of the investigator, might interfere with the study objectives
Participation in another clinical trial within 30 days of Screening or while participating in the current study, including the 28 days of follow-up post study drug administration
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gurdyal Kalsi, MD
Organizational Affiliation
Asklepion Pharmaceuticals, LLC
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Loma Linda University Children's Hospital
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Facility Name
University of California Davis Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Children's Hospital Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Children's National Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Nicklaus Children's Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Facility Name
Arnold Palmer Hospital for Children
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Advocate Children's Hospital
City
Oak Lawn
State/Province
Illinois
ZIP/Postal Code
60453
Country
United States
Facility Name
Riley Hospital for Children at Indiana University
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
The Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216-4505
Country
United States
Facility Name
St Louis University, SSM Health Cardinal Glennon Children's Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63104
Country
United States
Facility Name
Washington University School of Medicine/ St Louis Children's Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
The Children's Hospital at Montefiore
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Facility Name
Nationwide Children's Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States
Facility Name
Primary Children's Hospital
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84113
Country
United States
Facility Name
Seattle Children's Hospital
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Facility Name
University of Wisconsin
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792-1690
Country
United States
Facility Name
LKH-Universitätsklinikum Graz Universitätsklinik für Kinder- und Jugendheilkunde
City
Graz
ZIP/Postal Code
8036
Country
Austria
Facility Name
Medizinische Universität Wien, Klinik für Kinder- und Jugendheilkunde, Abteilung für Pädiatrische Kardiologie Kinderherzzentrum
City
Wien
ZIP/Postal Code
1050
Country
Austria
Facility Name
Universitätsmedizin Göttingen
City
Göttingen
ZIP/Postal Code
37075
Country
Germany
Facility Name
Medizinische Hochschule Hannover
City
Hanover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Klinik für Kinderkardiologie und angeborene Herzfehler. Deutsches Herzzentrum München - Klinik an der TU München
City
München
ZIP/Postal Code
80636
Country
Germany
Facility Name
Universitätsklinik Tübingen, Kinderkardiologie Pulmonologie, Intensivmedizin
City
Tübingen
ZIP/Postal Code
Tübingen
Country
Germany
Facility Name
Rambam Health Care Center
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Facility Name
Wolfson Medical Center
City
H̱olon
ZIP/Postal Code
5822012
Country
Israel
Facility Name
Sheba Medical Center
City
Ramat Gan
ZIP/Postal Code
5265601
Country
Israel
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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L-citrulline for Prevention of Sequelae of Acute Lung Injury in Pediatrics Undergoing Cardiopulmonary Bypass for Heart Defects
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