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Amino Acid
L-Citrulline for Congenital Heart Defects
Phase 3
Recruiting
Led By Christopher Mastropietro, MD, FCCM
Research Sponsored by Asklepion Pharmaceuticals, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1, 2, 4, 12, 24, and 48 hours post-dose
Awards & highlights
Study Summary
This trial will compare the effects of L-citrulline versus placebo on heart surgery patients with congenital defects.
Who is the study for?
This trial is for children under 18 with certain heart defects needing surgery, who can have a guardian sign consent. It's not for those with conditions affecting the study, pregnant girls or sexually active ones not using birth control, patients in other trials recently, on pulmonary hypertension meds, or with specific uncorrectable lung blood vessel issues.Check my eligibility
What is being tested?
The study tests if L-citrulline can prevent lung injury after heart defect surgery in kids. Patients are randomly chosen to get either L-citrulline or a placebo without knowing which one they receive. The safety and effectiveness of both treatments are compared.See study design
What are the potential side effects?
While the trial document does not specify side effects of L-citrulline, common ones may include stomach pain, heartburn, changes in urination patterns and possible allergic reactions. Side effects will be closely monitored throughout the trial.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 or younger and, if female, willing to use birth control.
Select...
I am having heart surgery to fix a hole in my heart.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1, 2, 4, 12, 24, and 48 hours post-dose
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1, 2, 4, 12, 24, and 48 hours post-dose
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Post-operative need for mechanical ventilation
Secondary outcome measures
Adverse events
Arterial blood gasses (HCO3)
Arterial blood gasses (PaCO2)
+29 moreSide effects data
From 2019 Phase 3 trial • 189 Patients • NCT0289183719%
Pyrexia
16%
Pain
14%
Restlessness
12%
Hypokalaemia
12%
Tachycardia
12%
Pleural effusion
12%
Hypertension
11%
Constipation
7%
Atelectasis
7%
Haemoglobin decreased
7%
Hypocalcaemia
6%
Hypotension
6%
Oligurea
6%
Vomiting
6%
Electrolyte imbalance
6%
Stridor
6%
Pulmonary oedema
5%
Chylothorax
5%
Tachypnoea
4%
Coagulation time prolonged
4%
C-reactive protein increased
4%
Metabolic acidosis
4%
Pulmonary congestion
4%
Anaemia
4%
Cough
4%
Diarrhoea
3%
Sinus bradycardia
3%
Blood creatine phosphokinase increased
3%
Blood lactate dehydrogenase increased
3%
Leukopenia
3%
Atrioventricular block complete
3%
Cardiac output decreased
2%
Thrombocytopenia
2%
Oedema peripheral
2%
Arrhythmia
2%
Cardiac failure
2%
Adrenal insufficiency
2%
Hypoalbuminaemia
2%
Aortic valve incompetence
2%
Post procedural haemorrhage
2%
Haematocrit decreased
1%
Aspartate aminotransferase increased
1%
Staphylococcal infection
1%
Nausea
1%
Cardiac tamponade
1%
Ventricular fibrillation
1%
Blood lactic acid increased
1%
Ventricular tachycardia
1%
Junctional ectopic tachycardia
1%
Swallow study abnormal
1%
Coagulopathy
1%
Leukocytosis
1%
Atrioventricular block
1%
Supraventricular extrasystoles
1%
Hypothermia
1%
Oedema
1%
Peripheral swelling
1%
Secretion discharge
1%
Respiratory arrest
1%
Hypomagnesaemia
1%
Respiratory failure
100%
80%
60%
40%
20%
0%
Study treatment Arm
L-citrulline - All Patients
L-citrulline - All Patients on Mechanical Ventilation for ≤48 Hours
L-citrulline - US Patients on Mechanical Ventilation for >48 Hours
Placebo - All Patients
L-citrulline - US Patients on Mechanical Ventilation for ≤48 Hours
L-citrulline - All Patients on Mechanical Ventilation for >48 Hours
Placebo - All Patients on Mechanical Ventilation for ≤48 Hours
Placebo - US Patients on Mechanical Ventilation for ≤48 Hours
Placebo - All Patients on Mechanical Ventilation for >48 Hours
Placebo - US Patients on Mechanical Ventilation for >48 Hours
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: ActiveExperimental Treatment1 Intervention
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.
Group II: PlaceboPlacebo Group1 Intervention
Plasmalyte A administered to the same schedule as the active treatment arm.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
L-citrulline
2010
Completed Phase 3
~530
Find a Location
Who is running the clinical trial?
Asklepion Pharmaceuticals, LLCLead Sponsor
5 Previous Clinical Trials
473 Total Patients Enrolled
Gurdyal Kalsi, MD, MFPMStudy DirectorAsklepion Pharmaceuticals, LLC
2 Previous Clinical Trials
185 Total Patients Enrolled
Christopher Mastropietro, MD, FCCMPrincipal InvestigatorRiley Hospital for Children at Indiana University Health
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have lung blood vessel issues that cannot be fixed with surgery.I am 18 or younger and, if female, willing to use birth control.I am using or willing to use birth control during the study.I am having heart surgery to fix a hole in my heart.I am taking medication for high blood pressure in my lungs before surgery.I have a type of high blood pressure in the lungs called pulmonary hypertension.I need a machine to help me breathe or IV medication to support my heart function before surgery.My heart's structure and the defect needing repair have been confirmed by an echocardiogram before surgery.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: Active
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Atrial Septal Defect Patient Testimony for trial: Trial Name: NCT05253209 — Phase 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many subjects are engaged in this experiment?
"That is accurate. The clinical trial in question, as indicated by information found on clinicaltrials.gov, is still looking for participants. This particular trial was posted on 6/29/2022 and updated as recently as 10/25/2022; at the moment, they are hoping to enroll 97 patients from 3 different locations."
Answered by AI
Are there any severe side effects to taking L-citrulline?
"L-citrulline has been studied in Phase 3 clinical trials, meaning there is some evidence of efficacy as well as multiple rounds of data supporting safety. Consequently, our team rates its safety at a 3."
Answered by AI
Are participants still being recruited for this research?
"Yes, this trial is recruiting patients as of right now. The most recent update to the listing was on October 25th, 2022 and it was first posted on June 29th of the same year."
Answered by AI
Who else is applying?
What state do they live in?
Indiana
What site did they apply to?
Riley Hospital for Children at Indiana University Health
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+
Why did patients apply to this trial?
I have tried multiple medications. I have also done Transcranial Magnetic Stimulation 3 times over the past 5 years without long lasting results for Depression.
PatientReceived no prior treatments
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