Phase 3
N=189
L-citrulline for Prevention of Sequelae of Acute Lung Injury in Pediatrics Undergoing Cardiopulmonary Bypass for Heart Defects
Acute Lung Injury
Bottom Line
View on ClinicalTrials.gov: NCT02891837 ↗Enrolled (actual)
189
Serious AEs
8.9%
Results posted
Feb 2023
Primary outcome: Primary: A Composite Variable Consisting of the Longer of Either (1) Length of Time on Mechanical Ventilation or (2) Length of Inotrope Use. — 3351.1; 3549.6 Minutes — p=0.4930
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- L-citrulline (Drug); Placebo (Other)
- Age
- Pediatric, Adult
- Sex
- All
- Sponsor
- Asklepion Pharmaceuticals, LLC
- Primary completion
- Jun 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY A Composite Variable Consisting of the Longer of Either (1) Length of Time on Mechanical Ventilation or (2) Length of Inotrope Use. |
1484.9; 1730.7 | 0.1560 |
| SECONDARY Length of Time on Mechanical Ventilation |
420.2; 649.7 | — |
| SECONDARY Length of Time on Positive Pressure Ventilation |
200.9; 358.0 | — |
| SECONDARY Length of Time of Inotrope Use |
1428.6; 1653.1 | — |
| SECONDARY Inotrope Score |
14.7; 17.4; 17.2; 13.5; 4.5; 4.5 | — |
| SECONDARY Hemodynamic Improvement: Heart Rate |
-43.9; -40.6; -14.1; 1.1; 10.0; 18.5 | — |
| SECONDARY Hemodynamic Improvement: Systemic Arterial Blood Pressure |
-17.9; -22.3; -3.8; -4.0; 7.3; 8.9 | — |
| SECONDARY Hemodynamic Improvement: Oxygen Saturation |
1.3; -1.8; 2.3; 1.5; 1.4; 0.7 | — |
| SECONDARY Hemodynamic Improvement: Central Venous Pressure |
-10.0; -6.8; -6.5; -5.2; 6.7; -5.2 | 0.0326 sig |
| SECONDARY Thoracotomy Output |
209.42; 194.35 | — |
| SECONDARY Length of Time of Intubation |
329.9; 386.5 | — |
| SECONDARY Length of Pediatric Intensive Care Unit (PICU) Stay |
5.6; 7.1 | — |
| SECONDARY Length of Time on Vasodilators |
617.9; 624.8 | — |
| SECONDARY Length of Hospitalization |
4.9; 4.8 | — |
| SECONDARY Patients With Plasma Concentrations of Citrulline |
2264.6; 26.7; 2625.4; 25.4; 760.1; 25.7 | — |
| SECONDARY Occurrence of Adverse and Serious Adverse Events |
48; 30; 20; 10; 47; 30 | — |
| SECONDARY Number of Patients With Refractory Hypotension |
— | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT02891837). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.