Ventricular Septal DefectPhase 3NCT05253209
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
A Phase 3 study testing L-citrulline and Plasmalyte A in people with Ventricular Septal Defect and Atrioventricular Septal Defect, run by Asklepion Pharmaceuticals, LLC at 10 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Ventricular Septal Defect, Atrioventricular Septal Defect, Primum Atrial Septal Defect
- What is being tested?
- L-citrulline and Plasmalyte A
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 10 sitesUnited States
- Study dates
- 29 Jun 2022to 10 May 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Children's Hospital of Colorado
Aurora, Colorado, 80045
Children's of Alabama
Birmingham, Alabama, 35233
Heart Center, Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611-2605
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Nationwide Children's Hospital- The Heart Center
Columbus, Ohio, 43215
Duke University Medical Center Surgical Office of Clinical Research (SOCR)
Durham, North Carolina, 27710
Riley Hospital for Children at Indiana University Health
Indianapolis, Indiana, 46202
University of Wisconsin-Madison
Madison, Wisconsin, 53792-4108
Seattle Children's Research Institute
Seattle, Washington, 98105
Cardinal Glennon Children's Hospital
St Louis, Missouri, 63104
About this study
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
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.
Read the 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.
- Being tested
- L-citrulline, Plasmalyte A
- Medical subject headings
- Heart Septal Defects, Ventricular, Atrioventricular Septal Defect, Partial atrioventricular canal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-citrullineDrug
Intravenous L-citrulline given for up to 48 hours
Plasmalyte ADrug
Intravenous Plasmalyte A given for up to 48 hours
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | Patients will receive:
1. an L-citrulline bolus of 150 mg/kg at the initiation of cardiopulmonary bypass
2. the addition L-citrulline to maintain a steady state target concentration of approximately 100 μmol/L of L-citrulline during cardiopulmonary bypass
3. 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. Receives: Drug: L-citrulline |
| Placebo | Placebo comparator | Plasmalyte A administered to the same schedule as the active treatment arm. Receives: Drug: Plasmalyte A |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Time in hours from separation from CPB until discontinuation of all mechanical ventilation including non-invasive support or Day 28, whichever occurs first
Secondary outcomes (32)
Intubation
Length of time on intubation
Measured: From separation from bypass until discontinuation of intubation or Day 28, whichever occurs first
Early extubation
Frequency of extubation <12 hours after surgery
Measured: From end of surgery until 12 hours post-surgery
Positive pressure ventilation
Length of time on non-invasive mechanical ventilation
Measured: Time in hours from separation from CPB until discontinuation of all non-invasive mechanical ventilation or Day 28, whichever occurs first
Duration of hospitalization
Number of post-operative days until discharge from hospital
Measured: From surgery until discharge from hospital or Day 28, whichever occurs first
Use of inotropes
Duration of inotrope use (e.g., dopamine, dobutamine, milrinone, epinephrine, phenylephrine and/or norepinephrine).
Measured: Measured from first use until discharge or Day 28, whichever occurs first
Use of vasodilators
Duration of vasodilator use (e.g., nitroprusside, nitroglycerin, and nicardipine)
Measured: Measured from first use until discharge or Day 28, whichever occurs first
Duration of chest tube placement
Total post-operative time chest tube is used
Measured: From the end of the surgery to the time the chest tube is removed or Day 28, whichever occurs first
Volume of chest tube drainage
Total amount of chest tube drainage (mL)
Measured: Duration of chest tube placement or Day 28, whichever occurs first
Hemodynamic improvement (heart rate)
Changes in heart rate measurements.
Measured: 1, 2, 4, 12, 24, and 48 hours post-dose
Hemodynamic improvement (systemic arterial blood pressure)
Changes in systemic arterial systolic and diastolic blood pressure measurements.
Measured: 1, 2, 4, 12, 24, and 48 hours post-dose
Hemodynamic improvement (oxygen saturation)
Changes in oxygen saturation measurements.
Measured: 1, 2, 4, 12, 24, and 48 hours post-dose
Hemodynamic improvement (central venous pressure)
Changes in oxygen saturation measurements.
Measured: 1, 2, 4, 12, 24, and 48 hours post-dose
Hemodynamic improvement (pulmonary arterial pressure)
Changes in PAP measurements (when available).
Measured: 1, 2, 4, 12, 24, and 48 hours post-dose
Arterial blood gasses (PaO2)
Changes in PaO2 measurements
Measured: Intra-operatively to Day 28
Arterial blood gasses (PaCO2)
Changes in PaCO2 measurements
Measured: Intra-operatively to Day 28
Arterial blood gasses (HCO3)
Changes in HCO3 measurements
Measured: Intra-operatively to Day 28
Arterial blood gasses (pH)
Changes in pH measurements
Measured: Intra-operatively to Day 28
Plasma levels of L-citrulline to assess PK-PD (exposure-response) relationship
Measurement of plasma levels of L-citrulline
Measured: Pre-surgery, 6, 12, 24 and 48 hours after first dose
Health Economics: mechanical ventilation
Measured as cost per day and expressed as incremental cost per quality adjusted life year (QALY) gained
Measured: Total over duration of hospitalization or to Day 28 whichever occurs first
Health Economics: duration of hospitalisation
Measured as total cost of hospitalisation expressed as incremental cost per quality adjusted life year (QALY) gained
Measured: Total over duration of hospitalization or to Day 28 whichever occurs first
Adverse events
Incidence of adverse events and serious adverse events
Measured: Pre-operatively until Day 28
Incidence of refractory hypotension
Number of subjects with any refractory hypotension. Defined as a drop of >20% in mean arterial pressure for >30 minutes.
Measured: From the end of surgery until 48 hours after first dose
Clinical laboratory values (Blood Hemoglobin and Total Bilirubin)
Absolute values and the absolute and percentage changes from baseline.
Measured: Intra-operatively, Days 1, 2 and 28
Clinical laboratory values (Blood Haematocrit)
Absolute values and the absolute and percentage changes from baseline.
Measured: Intra-operatively, Days 1, 2 and 28
Clinical laboratory values (Red Blood Cell Count)
Absolute values and the absolute and percentage changes from baseline.
Measured: Intra-operatively, Days 1, 2 and 28
Clinical laboratory values (White Blood Cell Count)
Absolute values and the absolute and percentage changes from baseline.
Measured: Intra-operatively, Days 1, 2 and 28
Clinical laboratory values (Blood Platelet Count)
Absolute values and the absolute and percentage changes from baseline.
Measured: Intra-operatively, Days 1, 2 and 28
Clinical laboratory values (Blood Sodium, Potassium, Calcium, Magnesium, Chloride)
Absolute values and the absolute and percentage changes from baseline.
Measured: Intra-operatively, Days 1, 2 and 28
Clinical laboratory values (Blood Urea Nitrogen and Creatinine)
Absolute values and the absolute and percentage changes from baseline.
Measured: Intra-operatively, Days 1, 2 and 28
Clinical laboratory values (Blood Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase)
Absolute values and the absolute and percentage changes from baseline.
Measured: Intra-operatively, Days 1, 2 and 28
Clinical laboratory values (Blood Lactate Dehydrogenase)
Absolute values and the absolute and percentage changes from baseline.
Measured: Intra-operatively, Days 1, 2 and 28
Clinical laboratory values (Blood Activated Clotting Time)
Absolute values and the absolute and percentage changes from baseline.
Measured: Intra-operatively, Days 1, 2 and 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2022
- Study start29 Jun 2022
- Primary completion10 May 2024
- Study completion10 May 2024
Why it stopped: Interim Analysis triggered futility
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventricular Septal DefectStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asklepion Pharmaceuticals, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christopher Mastropietro, MD, FCCM, Principal investigator, Riley Hospital for Children at Indiana University HealthGurdyal Kalsi, MD, MFPM, Study director, Asklepion Pharmaceuticals, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05253209
- Sponsor's protocol ID
- CIT-CPB-003-02
- Status last verified
- Aug 2023
- First submitted
- 24 Jan 2022
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05253209
- Acronym / sponsor ID
- CIT-CPB-003-02
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Interim Analysis triggered futility
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Asklepion Pharmaceuticals, LLCIndustry (pharma, biotech, devices)
- Study start
- 29 Jun 2022 (actual)
- Primary completion
- 10 May 2024 (actual)
- Study completion
- 10 May 2024 (actual)
- First posted
- 23 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | Drug: L-citrullinePatients will receive: 1. an L-citrulline bolus of 150 mg/kg at the initiation of cardiopulmonary bypass 2. the addition L-citrulline to maintain a steady state target concentration of approximately 100 μmol/L of L-citrulline during cardiopulmonary bypass 3. 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. |
| Placebo | Placebo comparator | Drug: Plasmalyte APlasmalyte A administered to the same schedule as the active treatment arm. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- Evidence of pulmonary artery or vein abnormalities that will not be addressed surgically. Specific abnormalities excluded include:
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| L-citrullineIntravenous L-citrulline given for up to 48 hours | Drug | Active |
| Plasmalyte AIntravenous Plasmalyte A given for up to 48 hours | Drug | Placebo |
Primary outcome
Post-operative need for mechanical ventilation
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
Mechanical ventilation is defined as invasive and non-invasive mechanical ventilation including bilevel positive airway pressure (BPAP), continuous positive airway pressure (CPAP)
32 secondary outcomes
Intubation
Time frame: From separation from bypass until discontinuation of intubation or Day 28, whichever occurs first
Early extubation
Time frame: From end of surgery until 12 hours post-surgery
Positive pressure ventilation
Time frame: Time in hours from separation from CPB until discontinuation of all non-invasive mechanical ventilation or Day 28, whichever occurs first
Duration of hospitalization
Time frame: From surgery until discharge from hospital or Day 28, whichever occurs first
Use of inotropes
Time frame: Measured from first use until discharge or Day 28, whichever occurs first
Use of vasodilators
Time frame: Measured from first use until discharge or Day 28, whichever occurs first
Duration of chest tube placement
Time frame: From the end of the surgery to the time the chest tube is removed or Day 28, whichever occurs first
Volume of chest tube drainage
Time frame: Duration of chest tube placement or Day 28, whichever occurs first
Hemodynamic improvement (heart rate)
Time frame: 1, 2, 4, 12, 24, and 48 hours post-dose
Hemodynamic improvement (systemic arterial blood pressure)
Time frame: 1, 2, 4, 12, 24, and 48 hours post-dose
Hemodynamic improvement (oxygen saturation)
Time frame: 1, 2, 4, 12, 24, and 48 hours post-dose
Hemodynamic improvement (central venous pressure)
Time frame: 1, 2, 4, 12, 24, and 48 hours post-dose
Hemodynamic improvement (pulmonary arterial pressure)
Time frame: 1, 2, 4, 12, 24, and 48 hours post-dose
Arterial blood gasses (PaO2)
Time frame: Intra-operatively to Day 28
Arterial blood gasses (PaCO2)
Time frame: Intra-operatively to Day 28
Arterial blood gasses (HCO3)
Time frame: Intra-operatively to Day 28
Arterial blood gasses (pH)
Time frame: Intra-operatively to Day 28
Plasma levels of L-citrulline to assess PK-PD (exposure-response) relationship
Time frame: Pre-surgery, 6, 12, 24 and 48 hours after first dose
Health Economics: mechanical ventilation
Time frame: Total over duration of hospitalization or to Day 28 whichever occurs first
Health Economics: duration of hospitalisation
Time frame: Total over duration of hospitalization or to Day 28 whichever occurs first
Adverse events
Time frame: Pre-operatively until Day 28
Incidence of refractory hypotension
Time frame: From the end of surgery until 48 hours after first dose
Clinical laboratory values (Blood Hemoglobin and Total Bilirubin)
Time frame: Intra-operatively, Days 1, 2 and 28
Clinical laboratory values (Blood Haematocrit)
Time frame: Intra-operatively, Days 1, 2 and 28
Clinical laboratory values (Red Blood Cell Count)
Time frame: Intra-operatively, Days 1, 2 and 28
Clinical laboratory values (White Blood Cell Count)
Time frame: Intra-operatively, Days 1, 2 and 28
Clinical laboratory values (Blood Platelet Count)
Time frame: Intra-operatively, Days 1, 2 and 28
Clinical laboratory values (Blood Sodium, Potassium, Calcium, Magnesium, Chloride)
Time frame: Intra-operatively, Days 1, 2 and 28
Clinical laboratory values (Blood Urea Nitrogen and Creatinine)
Time frame: Intra-operatively, Days 1, 2 and 28
Clinical laboratory values (Blood Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase)
Time frame: Intra-operatively, Days 1, 2 and 28
Clinical laboratory values (Blood Lactate Dehydrogenase)
Time frame: Intra-operatively, Days 1, 2 and 28
Clinical laboratory values (Blood Activated Clotting Time)
Time frame: Intra-operatively, Days 1, 2 and 28
Results and safety
The study was stopped early (reason given: Interim Analysis triggered futility). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher Mastropietro, MD, FCCM principal investigator
Riley Hospital for Children at Indiana University Health
Gurdyal Kalsi, MD, MFPM study director
Asklepion Pharmaceuticals, LLC
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing L-citrulline and Plasmalyte A in people with Ventricular Septal Defect and Atrioventricular Septal Defect, run by Asklepion Pharmaceuticals, LLC at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Interim Analysis triggered futility). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative need for mechanical ventilation (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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.