Back to resultsA Study Evaluating the Efficacy and Safety of IV L-Citrulline for the Prevention of Clinical Sequelae of Acute Lung Injury Induced by Cardiopulmonary Bypass in Pediatric Patients Undergoing Surgery for Congenital Heart Defects
Primary Purpose
Ventricular Septal Defect, Atrioventricular Septal Defect, Primum Atrial Septal Defect
Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
L-citrulline
Plasmalyte A
Sponsored by
About this trial
This is an interventional prevention trial for Ventricular Septal Defect
Eligibility Criteria
Inclusion Criteria:
- Patients, parents, or legal guardian willing and able to sign informed consent
- Male and female subjects aged ≤18 years of age (females of child-bearing potential willing to practice an acceptable form of birth control)
- Patients undergoing cardiopulmonary bypass for repair of a large unrestrictive ventricular septal defect, an ostium primum/secundum atrial septal defect, or a partial or complete atrioventricular septal defect
- Pre-operative echocardiogram confirming cardiovascular anatomy and defect to be repaired
Exclusion Criteria:
Evidence of pulmonary artery or vein abnormalities that will not be addressed surgically. Specific abnormalities excluded include:
- 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 IV 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; Sexually active females of child-bearing potential must be willing to practice an acceptable method of birth control for the duration of study participation (e.g. oral contraceptive, hormonal implant, intra-uterine device)
- 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.
- Any condition which, in the opinion of the investigator, might interfere with the study objectives
Sites / Locations
- Children's of AlabamaRecruiting
- Children's Hospital of ColoradoRecruiting
- Heart Center, Ann & Robert H. Lurie Children's Hospital of ChicagoRecruiting
- Riley Hospital for Children at Indiana University HealthRecruiting
- Cardinal Glennon Children's HospitalRecruiting
- Duke University Medical Center Surgical Office of Clinical Research (SOCR)Recruiting
- Cincinnati Children's Hospital Medical CenterRecruiting
- Nationwide Children's Hospital- The Heart CenterRecruiting
- Seattle Children's Research InstituteRecruiting
- University of Wisconsin-MadisonRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Active
Placebo
Arm Description
Patients will receive: an L-citrulline bolus of 150 mg/kg at the initiation of cardiopulmonary bypass the addition L-citrulline to maintain a steady state target concentration of approximately 100 μmol/L of L-citrulline during cardiopulmonary bypass an L-citrulline bolus of 10 mg/kg 30 minutes after decannulation from cardiopulmonary bypass, followed immediately by a 9 mg/kg/hour continuous L-citrulline infusion or placebo for up to 48 hours post-first dose. The infusion rate will be adjusted (up or down titration of drug infusion) to achieve a target steady state concentration of 100 μmol/L. Infusion will be discontinued once invasive arterial blood pressure monitoring is discontinued or at 48 hours, whichever occurs first.
Plasmalyte A administered to the same schedule as the active treatment arm.
Outcomes
Primary Outcome Measures
Post-operative need for mechanical ventilation
Mechanical ventilation is defined as invasive and non-invasive mechanical ventilation including bilevel positive airway pressure (BPAP), continuous positive airway pressure (CPAP)
Secondary Outcome Measures
Intubation
Length of time on intubation
Early extubation
Frequency of extubation <12 hours after surgery
Positive pressure ventilation
Length of time on non-invasive mechanical ventilation
Duration of hospitalization
Number of post-operative days until discharge from hospital
Use of inotropes
Duration of inotrope use (e.g., dopamine, dobutamine, milrinone, epinephrine, phenylephrine and/or norepinephrine).
Use of vasodilators
Duration of vasodilator use (e.g., nitroprusside, nitroglycerin, and nicardipine)
Duration of chest tube placement
Total post-operative time chest tube is used
Volume of chest tube drainage
Total amount of chest tube drainage (mL)
Hemodynamic improvement (heart rate)
Changes in heart rate measurements.
Hemodynamic improvement (systemic arterial blood pressure)
Changes in systemic arterial systolic and diastolic blood pressure measurements.
Hemodynamic improvement (oxygen saturation)
Changes in oxygen saturation measurements.
Hemodynamic improvement (central venous pressure)
Changes in oxygen saturation measurements.
Hemodynamic improvement (pulmonary arterial pressure)
Changes in PAP measurements (when available).
Arterial blood gasses (PaO2)
Changes in PaO2 measurements
Arterial blood gasses (PaCO2)
Changes in PaCO2 measurements
Arterial blood gasses (HCO3)
Changes in HCO3 measurements
Arterial blood gasses (pH)
Changes in pH measurements
Plasma levels of L-citrulline to assess PK-PD (exposure-response) relationship
Measurement of plasma levels of L-citrulline
Health Economics: mechanical ventilation
Measured as cost per day and expressed as incremental cost per quality adjusted life year (QALY) gained
Health Economics: duration of hospitalisation
Measured as total cost of hospitalisation expressed as incremental cost per quality adjusted life year (QALY) gained
Adverse events
Incidence of adverse events and serious adverse events
Incidence of refractory hypotension
Number of subjects with any refractory hypotension. Defined as a drop of >20% in mean arterial pressure for >30 minutes.
Clinical laboratory values (Blood Hemoglobin and Total Bilirubin)
Absolute values and the absolute and percentage changes from baseline.
Clinical laboratory values (Blood Haematocrit)
Absolute values and the absolute and percentage changes from baseline.
Clinical laboratory values (Red Blood Cell Count)
Absolute values and the absolute and percentage changes from baseline.
Clinical laboratory values (White Blood Cell Count)
Absolute values and the absolute and percentage changes from baseline.
Clinical laboratory values (Blood Platelet Count)
Absolute values and the absolute and percentage changes from baseline.
Clinical laboratory values (Blood Sodium, Potassium, Calcium, Magnesium, Chloride)
Absolute values and the absolute and percentage changes from baseline.
Clinical laboratory values (Blood Urea Nitrogen and Creatinine)
Absolute values and the absolute and percentage changes from baseline.
Clinical laboratory values (Blood Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase)
Absolute values and the absolute and percentage changes from baseline.
Clinical laboratory values (Blood Lactate Dehydrogenase)
Absolute values and the absolute and percentage changes from baseline.
Clinical laboratory values (Blood Activated Clotting Time)
Absolute values and the absolute and percentage changes from baseline.
Full Information
NCT ID
NCT05253209
First Posted
January 24, 2022
Last Updated
August 17, 2023
Sponsor
Asklepion Pharmaceuticals, LLC
1. Study Identification
Unique Protocol Identification Number
NCT05253209
Brief Title
A Study Evaluating the Efficacy and Safety of IV L-Citrulline for the Prevention of Clinical Sequelae of Acute Lung Injury Induced by Cardiopulmonary Bypass in Pediatric Patients Undergoing Surgery for Congenital 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 Patients Undergoing Surgery for Congenital Heart Defects
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 29, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
February 10, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Asklepion Pharmaceuticals, LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a randomized, double-blind, placebo controlled, multicenter study to compare the efficacy and safety of L-citrulline versus placebo in patients undergoing surgery for congenital heart defects. Eligible patients 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.
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 patients undergoing surgery for congenital heart defects. Eligible patients 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.
Each enrolled patient will be randomized to receive either L citrulline or placebo throughout all administrations in the study. Patients will receive:
an L-citrulline bolus of 150 mg/kg or placebo at the initiation of cardiopulmonary bypass
the addition L-citrulline or placebo to maintain a steady state target concentration of approximately 100 μmol/L of L-Citrulline or placebo during cardiopulmonary bypass
an L-citrulline bolus of 10 mg/kg or placebo 30 minutes after decannulation from cardiopulmonary bypass, followed immediately by a 9 mg/kg/hour continuous L-citrulline infusion or placebo for up to 48 hours post-first dose. The infusion rate will be adjusted (up or down titration of drug infusion) to achieve a target steady state concentration of 100 µmol/L.
The study drug or placebo infusion will be discontinued once invasive arterial blood pressure monitoring is discontinued or at 48 hours, whichever occurs first. Patients will be followed until Day 28 or discharge from the hospital, whichever occurs first. For patients 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
Ventricular Septal Defect, Atrioventricular Septal Defect, Primum Atrial Septal Defect
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Randomization via an IWRS. Study drug or placebo will be prepared and labeled with the appropriate subject identifiers only; no information that would reveal the contents of the dose to be administered (active versus placebo) will be included on the label. Study drug (citrulline or placebo) will be provided in either identical syringes or bags and mask labeled. The bags will be the same size, shape, and fluid clarity, and hence masked to both investigators and staff administering the drug. Only the pharmacist and the unblinded monitor responsible for performing drug accountability (a different monitor than the person performing routine data monitoring) will be aware of the treatment assignment.
Allocation
Randomized
Enrollment
97 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Active
Arm Type
Experimental
Arm Description
Patients will receive:
an L-citrulline bolus of 150 mg/kg at the initiation of cardiopulmonary bypass
the addition L-citrulline to maintain a steady state target concentration of approximately 100 μmol/L of L-citrulline during cardiopulmonary bypass
an L-citrulline bolus of 10 mg/kg 30 minutes after decannulation from cardiopulmonary bypass, followed immediately by a 9 mg/kg/hour continuous L-citrulline infusion or placebo for up to 48 hours post-first dose. The infusion rate will be adjusted (up or down titration of drug infusion) to achieve a target steady state concentration of 100 μmol/L.
Infusion will be discontinued once invasive arterial blood pressure monitoring is discontinued or at 48 hours, whichever occurs first.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Plasmalyte A administered to the same schedule as the active treatment arm.
Intervention Type
Drug
Intervention Name(s)
L-citrulline
Intervention Description
Intravenous L-citrulline given for up to 48 hours
Intervention Type
Drug
Intervention Name(s)
Plasmalyte A
Intervention Description
Intravenous Plasmalyte A given for up to 48 hours
Primary Outcome Measure Information:
Title
Post-operative need for mechanical ventilation
Description
Mechanical ventilation is defined as invasive and non-invasive mechanical ventilation including bilevel positive airway pressure (BPAP), continuous positive airway pressure (CPAP)
Time Frame
Time in hours from separation from CPB until discontinuation of all mechanical ventilation including non-invasive support or Day 28, whichever occurs first
Secondary Outcome Measure Information:
Title
Intubation
Description
Length of time on intubation
Time Frame
From separation from bypass until discontinuation of intubation or Day 28, whichever occurs first
Title
Early extubation
Description
Frequency of extubation <12 hours after surgery
Time Frame
From end of surgery until 12 hours post-surgery
Title
Positive pressure ventilation
Description
Length of time on non-invasive mechanical ventilation
Time Frame
Time in hours from separation from CPB until discontinuation of all non-invasive mechanical ventilation or Day 28, whichever occurs first
Title
Duration of hospitalization
Description
Number of post-operative days until discharge from hospital
Time Frame
From surgery until discharge from hospital or Day 28, whichever occurs first
Title
Use of inotropes
Description
Duration of inotrope use (e.g., dopamine, dobutamine, milrinone, epinephrine, phenylephrine and/or norepinephrine).
Time Frame
Measured from first use until discharge or Day 28, whichever occurs first
Title
Use of vasodilators
Description
Duration of vasodilator use (e.g., nitroprusside, nitroglycerin, and nicardipine)
Time Frame
Measured from first use until discharge or Day 28, whichever occurs first
Title
Duration of chest tube placement
Description
Total post-operative time chest tube is used
Time Frame
From the end of the surgery to the time the chest tube is removed or Day 28, whichever occurs first
Title
Volume of chest tube drainage
Description
Total amount of chest tube drainage (mL)
Time Frame
Duration of chest tube placement or Day 28, whichever occurs first
Title
Hemodynamic improvement (heart rate)
Description
Changes in heart rate measurements.
Time Frame
1, 2, 4, 12, 24, and 48 hours post-dose
Title
Hemodynamic improvement (systemic arterial blood pressure)
Description
Changes in systemic arterial systolic and diastolic blood pressure measurements.
Time Frame
1, 2, 4, 12, 24, and 48 hours post-dose
Title
Hemodynamic improvement (oxygen saturation)
Description
Changes in oxygen saturation measurements.
Time Frame
1, 2, 4, 12, 24, and 48 hours post-dose
Title
Hemodynamic improvement (central venous pressure)
Description
Changes in oxygen saturation measurements.
Time Frame
1, 2, 4, 12, 24, and 48 hours post-dose
Title
Hemodynamic improvement (pulmonary arterial pressure)
Description
Changes in PAP measurements (when available).
Time Frame
1, 2, 4, 12, 24, and 48 hours post-dose
Title
Arterial blood gasses (PaO2)
Description
Changes in PaO2 measurements
Time Frame
Intra-operatively to Day 28
Title
Arterial blood gasses (PaCO2)
Description
Changes in PaCO2 measurements
Time Frame
Intra-operatively to Day 28
Title
Arterial blood gasses (HCO3)
Description
Changes in HCO3 measurements
Time Frame
Intra-operatively to Day 28
Title
Arterial blood gasses (pH)
Description
Changes in pH measurements
Time Frame
Intra-operatively to Day 28
Title
Plasma levels of L-citrulline to assess PK-PD (exposure-response) relationship
Description
Measurement of plasma levels of L-citrulline
Time Frame
Pre-surgery, 6, 12, 24 and 48 hours after first dose
Title
Health Economics: mechanical ventilation
Description
Measured as cost per day and expressed as incremental cost per quality adjusted life year (QALY) gained
Time Frame
Total over duration of hospitalization or to Day 28 whichever occurs first
Title
Health Economics: duration of hospitalisation
Description
Measured as total cost of hospitalisation expressed as incremental cost per quality adjusted life year (QALY) gained
Time Frame
Total over duration of hospitalization or to Day 28 whichever occurs first
Title
Adverse events
Description
Incidence of adverse events and serious adverse events
Time Frame
Pre-operatively until Day 28
Title
Incidence of refractory hypotension
Description
Number of subjects with any refractory hypotension. Defined as a drop of >20% in mean arterial pressure for >30 minutes.
Time Frame
From the end of surgery until 48 hours after first dose
Title
Clinical laboratory values (Blood Hemoglobin and Total Bilirubin)
Description
Absolute values and the absolute and percentage changes from baseline.
Time Frame
Intra-operatively, Days 1, 2 and 28
Title
Clinical laboratory values (Blood Haematocrit)
Description
Absolute values and the absolute and percentage changes from baseline.
Time Frame
Intra-operatively, Days 1, 2 and 28
Title
Clinical laboratory values (Red Blood Cell Count)
Description
Absolute values and the absolute and percentage changes from baseline.
Time Frame
Intra-operatively, Days 1, 2 and 28
Title
Clinical laboratory values (White Blood Cell Count)
Description
Absolute values and the absolute and percentage changes from baseline.
Time Frame
Intra-operatively, Days 1, 2 and 28
Title
Clinical laboratory values (Blood Platelet Count)
Description
Absolute values and the absolute and percentage changes from baseline.
Time Frame
Intra-operatively, Days 1, 2 and 28
Title
Clinical laboratory values (Blood Sodium, Potassium, Calcium, Magnesium, Chloride)
Description
Absolute values and the absolute and percentage changes from baseline.
Time Frame
Intra-operatively, Days 1, 2 and 28
Title
Clinical laboratory values (Blood Urea Nitrogen and Creatinine)
Description
Absolute values and the absolute and percentage changes from baseline.
Time Frame
Intra-operatively, Days 1, 2 and 28
Title
Clinical laboratory values (Blood Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase)
Description
Absolute values and the absolute and percentage changes from baseline.
Time Frame
Intra-operatively, Days 1, 2 and 28
Title
Clinical laboratory values (Blood Lactate Dehydrogenase)
Description
Absolute values and the absolute and percentage changes from baseline.
Time Frame
Intra-operatively, Days 1, 2 and 28
Title
Clinical laboratory values (Blood Activated Clotting Time)
Description
Absolute values and the absolute and percentage changes from baseline.
Time Frame
Intra-operatively, Days 1, 2 and 28
10. Eligibility
Sex
All
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients, parents, or legal guardian willing and able to sign informed consent
Male and female subjects aged ≤18 years of age (females of child-bearing potential willing to practice an acceptable form of birth control)
Patients undergoing cardiopulmonary bypass for repair of a large unrestrictive ventricular septal defect, an ostium primum/secundum atrial septal defect, or a partial or complete atrioventricular septal defect
Pre-operative echocardiogram confirming cardiovascular anatomy and defect to be repaired
Exclusion Criteria:
Evidence of pulmonary artery or vein abnormalities that will not be addressed surgically. Specific abnormalities excluded include:
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 IV 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; Sexually active females of child-bearing potential must be willing to practice an acceptable method of birth control for the duration of study participation (e.g. oral contraceptive, hormonal implant, intra-uterine device)
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.
Any condition which, in the opinion of the investigator, might interfere with the study objectives
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gurdyal Kalsi, MD, MFPM
Phone
+1 410.736.3750
Email
gurdyal.kalsi@asklepionpharm.com
First Name & Middle Initial & Last Name or Official Title & Degree
Heather Hill
Phone
+1 443.839.5726
Email
heather.hill@asklepionpharm.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher Mastropietro, MD, FCCM
Organizational Affiliation
Riley Hospital for Children at Indiana University Health
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gurdyal Kalsi, MD, MFPM
Organizational Affiliation
Asklepion Pharmaceuticals, LLC
Official's Role
Study Director
Facility Information:
Facility Name
Children's of Alabama
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed Asfari, MD
Phone
205-638-5216
Email
aasfari@uabmc.edu
First Name & Middle Initial & Last Name & Degree
Ahmed Asfari, MD
Facility Name
Children's Hospital of Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Benjamin Frank, MD
Phone
720-777-5674
First Name & Middle Initial & Last Name & Degree
Benjamin Frank, MD
Facility Name
Heart Center, Ann & Robert H. Lurie Children's Hospital of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611-2605
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Monge, MD
Phone
312-227-5395
First Name & Middle Initial & Last Name & Degree
Michael Monge, MD
Facility Name
Riley Hospital for Children at Indiana University Health
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christopher Mastropietro, MD
Phone
317-944-5165
Email
cmastrop@iupui.edu
First Name & Middle Initial & Last Name & Degree
Christopher Mastropietro
Facility Name
Cardinal Glennon Children's Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erik Masden, MD
Phone
314-577-5600
Ext
7629
Email
erik.madsen@health.slu.edu
First Name & Middle Initial & Last Name & Degree
Erik Masden, MD
Facility Name
Duke University Medical Center Surgical Office of Clinical Research (SOCR)
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ziv Beckerman, MD
Phone
919-613-6585
First Name & Middle Initial & Last Name & Degree
Ziv Beckerman, MD
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexis Benscoter, DO
Phone
513-803-4942
Email
Alexis.Ramby@cchmc.org
First Name & Middle Initial & Last Name & Degree
Alexis Benscoter, DO
Facility Name
Nationwide Children's Hospital- The Heart Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Janet Simsic, MD
Phone
614-355-5763
Email
Janet.Simsic@nationwidechildrens.org
First Name & Middle Initial & Last Name & Degree
Janet Simsic, MD
Facility Name
Seattle Children's Research Institute
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Monique Radman, MD, MAS
Phone
206-987-5721
Email
Monique.Radman@seattlechildrens.org
First Name & Middle Initial & Last Name & Degree
Monique Radman, MD, MAS
Facility Name
University of Wisconsin-Madison
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792-4108
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Petros Anagnostopoulos
Phone
608-576-0788
Email
surgeryresearch@surgery.wisc.edu
First Name & Middle Initial & Last Name & Degree
Petros Anagnostopoulos
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
A Study Evaluating the Efficacy and Safety of IV L-Citrulline for the Prevention of Clinical Sequelae of Acute Lung Injury Induced by Cardiopulmonary Bypass in Pediatric Patients Undergoing Surgery for Congenital Heart Defects
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