Phase 2
N=22
Intravenous L-Citrulline to Treat Children Undergoing Heart Bypass Surgery : Revised Protocol
Atrial Septal Defect · Ventricular Septal Defect · Atrioventricular Septal Defect
Bottom Line
View on ClinicalTrials.gov: NCT01120964 ↗Enrolled (actual)
22
Serious AEs
0.0%
Results posted
Jun 2022
Primary outcome: Primary: L-citrulline Plasma Levels — 200.9; 34.1; 2405.9; 29.5 µmol/L
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Intravenous L-Citrulline (Drug); Placebo of Intravenous L-Citrulline (Drug)
- Age
- Pediatric
- Sex
- All
- Sponsor
- Asklepion Pharmaceuticals, LLC
- Primary completion
- Apr 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY L-citrulline Plasma Levels |
200.9; 34.1; 2405.9; 29.5; 890.9; 30.6 | — |
| SECONDARY Postoperative Invasive Mechanical Ventilation (Mean and SD) |
5.1; 37.1; 5.1; 24.7 | 0.0222 sig |
| SECONDARY Postoperative Invasive Mechanical Ventilation (Median and Range) |
0.0; 21.7; 0.0; 21.7 | 0.0222 sig |
| SECONDARY Total Duration of Respiratory Support |
31.2; 81.9 | 0.0418 sig |
| SECONDARY Postoperative Intravenous Inotrope Duration |
13.4; 26.1 | 0.0727 |
| SECONDARY Total Inotrope Score |
602.7; 1162.6 | 0.1271 |
| SECONDARY Time on Vasoactive Medications |
6.3; 9.8 | 0.9720 |
| SECONDARY Total Vasoactive Score |
5.5; 10.6 | 0.8884 |
| SECONDARY Length of ICU Stay |
35.94; 105.08; 14.5; 44.4; 14.5; 32.0 | 0.1891 |
| SECONDARY Composite Endpoint: Cessation of Positive Pressure Ventilation and of Inotrope Therapy |
14.3; 44.4; 14.3; 32.0 | 0.0479 sig |
| SECONDARY Length of Hospitalization |
4.6; 8.4 | 0.2637 |
| SECONDARY Incidence of Increased PVT (Defined as a Sustained Mean Pulmonary Artery Pressure Greater Than 20 mm Hg for at Least 2 Hours, Measured During the First 48 Hours |
— | — |
| SECONDARY Duration of Chest Tube Drainage |
82.7; 90.2 | 0.6431 |
| SECONDARY Volume of Chest Tube Drainage |
211; 240 | 0.6408 |
| SECONDARY Survival |
11; 11 | — |
| SECONDARY Number of Patients With Clinically Significant Hypotension. |
2; 1 | — |
Summary
This clinical trial will determine the safety and effectiveness of intravenous L-citrulline in children undergoing cardiopulmonary bypass during heart surgery. Participants will be randomly assigned to either L-citrulline or a placebo (a substance that has no medicine in it).
Citrulline is a protein building block in the body that can convert into another substance, nitric oxide (NO), which controls blood pressure in the lungs. Increased blood pressure in the lungs can be an important surgical problem; it may also lead to problems following surgery, such as severe high blood pressure in the lungs (pulmonary hypertension), increased time spent on a breathing machine, and a longer stay in the intensive care unit (ICU). The hypothesis of this study is that perioperative supplementation with intravenous citrulline will increase plasma citrulline, arginine and NO metabolites and prevent elevations in the postoperative PVT leading to a decrease in the duration of postoperative invasive mechanical ventilation.
The objective of this study is to determine in a randomized placebo controlled phase IB multicenter clinical trial if a revised protocol of intravenous L-citrulline delivery given perioperatively achieves a plasma citrulline level of > 100 umol/L in children undergoing surgical repair of an atrial septal defect,ventricular septal defect or an atrioventricular septal defect.
Eligibility Criteria
Inclusion Criteria
- Informed Consent signed by the subject's legal representative
- Subjects < 6 years old
- Subjects undergoing cardiopulmonary bypass for repair of an atrial septal defect, a ventricular septal defect or an atrioventricular septal defect
Exclusion Criteria
- Pulmonary artery or vein abnormalities being addressed surgically
- Preoperative requirement for invasive mechanical ventilation or intravenous inotrope support
- Any condition which, in the opinion of the investigator, might interfere with study objectives
Data sourced from ClinicalTrials.gov (NCT01120964). 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.