Clinical trial
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
Name
CIT-003-01
Description
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.
Trial arms
Trial start
2016-08-01
Estimated PCD
2019-06-01
Trial end
2019-07-01
Status
Completed
Phase
Early phase I
Treatment
L-citrulline
* 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.
Arms:
L-citrulline
Placebo
* 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.
Arms:
Placebo
Size
189
Primary endpoint
A Composite Variable Consisting of the Longer of Either (1) Length of Time on Mechanical Ventilation or (2) Length of Inotrope Use.
28 Days
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 189, 'type': 'ACTUAL'}}
Updated at
2023-02-23
1 organization
1 product
1 indication
Product
L-citrullineIndication
ALIOrganization
Asklepion Pharmaceuticals