Acute Lung InjuryPhase 3NCT02891837
L-citrulline for Prevention of Sequelae of Acute Lung Injury in Pediatrics Undergoing Cardiopulmonary Bypass for Heart Defects
A Phase 3 study testing L-citrulline in people with Acute Lung Injury, run by Asklepion Pharmaceuticals, LLC at 29 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Acute Lung Injury
- What is being tested?
- L-citrulline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 189 participants
- Where
- 29 sitesin 4 countries
- Study dates
- Aug 2016to Jul 2019
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
29 sites in 4 countries.
29 sites in 4 countries
United States20 sites
Children's Hospital Colorado
Aurora, Colorado, 80045
The Johns Hopkins Hospital
Baltimore, Maryland, 21287
University of Alabama
Birmingham, Alabama, 35233
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Nationwide Children's Hospital
Columbus, Ohio, 43215
Riley Hospital for Children at Indiana University
Indianapolis, Indiana, 46202
University of Mississippi Medical Center
Jackson, Mississippi, 39216-4505
Loma Linda University Children's Hospital
Loma Linda, California, 92354
University of Wisconsin
Madison, Wisconsin, 53792-1690
Nicklaus Children's Hospital
Miami, Florida, 33155
Columbia University Medical Center
New York, New York, 10032
Advocate Children's Hospital
Oak Lawn, Illinois, 60453
Arnold Palmer Hospital for Children
Orlando, Florida, 32806
University of California Davis Medical Center
Sacramento, California, 95817
Primary Children's Hospital
Salt Lake City, Utah, 84113
Seattle Children's Hospital
Seattle, Washington, 98105
St Louis University, SSM Health Cardinal Glennon Children's Hospital
St Louis, Missouri, 63104
Washington University School of Medicine/ St Louis Children's Hospital
St Louis, Missouri, 63110
The Children's Hospital at Montefiore
The Bronx, New York, 10467
Children's National Medical Center
Washington D.C., District of Columbia, 20010
Germany4 sites
Universitätsmedizin Göttingen
Göttingen, 37075
Medizinische Hochschule Hannover
Hanover, 30625
Klinik für Kinderkardiologie und angeborene Herzfehler. Deutsches Herzzentrum München - Klinik an der TU München
München, 80636
Universitätsklinik Tübingen, Kinderkardiologie Pulmonologie, Intensivmedizin
Tübingen, Tübingen
Israel3 sites
Rambam Health Care Center
Haifa, 3109601
Wolfson Medical Center
Holon, 5822012
Sheba Medical Center
Ramat Gan, 5265601
Austria2 sites
LKH-Universitätsklinikum Graz Universitätsklinik für Kinder- und Jugendheilkunde
Graz, 8036
Medizinische Universität Wien, Klinik für Kinder- und Jugendheilkunde, Abteilung für Pädiatrische Kardiologie Kinderherzzentrum
Vienna, 1050
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 Subjects Undergoing Surgery for Congenital Heart Defects
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.
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 subjects undergoing surgery for congenital heart defects.
Eligible subjects 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 in this study.
Each enrolled subject will be randomized to receive either L-citrulline or placebo throughout all administrations in the study. Subjects will receive an L-citrulline bolus of 150 mg/kg or placebo at the initiation of cardiopulmonary bypass, the addition of L-citrulline at a concentration of 200 μmol/L or placebo 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. L-citrulline bolus of 20 mg/kg or placebo 30 minutes after decannulation from cardiopulmonary bypass, followed immediately by a 9 mg/kg/hr continuous L-citrulline infusion or placebo for up to 48 hours.
The study drug or placebo infusion will be discontinued once invasive arterial blood pressure monitoring is discontinued or at 48 hours, whichever comes first. Subjects will be followed until Day 28 or discharge from the hospital, whichever comes first. For subjects discharged prior to Day 28, a final assessment via telephone will be conducted at Day 28.
- Conditions
- Acute Lung Injury
- Being tested
- L-citrulline, Placebo
- Keywords
- L-citrulline, pediatric, Lung Injury, Bypass, Heart Defects, Clinical Sequelae
- Medical subject headings
- Acute Lung Injury, Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-citrullineDrug
- 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.
PlaceboOther
- 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.
| Study group | Role | What they receive |
|---|---|---|
| L-citrulline | Experimental | * 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. Receives: Drug: L-citrulline |
| Placebo | Placebo comparator | * 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
A Composite Variable Consisting of the Longer of Either (1) Length of Time on Mechanical Ventilation or (2) Length of Inotrope Use.
Mechanical ventilation (MV) = invasive or noninvasive MV incl. bilevel (biphasic) positive airway pressure or continuous positive airway pressure. Inotrope use = medications considered within the derivation of total inotrope score (dopamine, dobutamine, milrinone, epinephrine, phenylephrine, norepinephrine). Both measures recorded until earliest of subject hospital discharge or Day 28.
Measured: 28 Days
Secondary outcomes (16)
Length of Time on Mechanical Ventilation
The same definitions and analyses as described for the primary endpoint will be applied.
Measured: 28 Days
Length of Time on Positive Pressure Ventilation
The same definitions and analyses as described for the primary endpoint will be applied.
Measured: 28 Days
Length of Time of Inotrope Use
The same definitions and analyses as described for the primary endpoint will be applied.
Measured: 28 days
Inotrope Score
Inotrope score is reflective of the pharmacological support required by the cardiovascular system and is a good predictor of mortality and morbidity in patients undergoing bypass surgery. A lower inotrope score represents less pharmacological support and would indicate a lower risk for a poor clinical outcome. Therefore, any treatment effect would be indicated by a lower inotrope score in the citrulline group when compared to the placebo group.
In this study, the score was calculated each hour post-operatively from the time of separation from bypass until the completion of study drug. Additionally, the total inotrope score over time until Day 28 or hospital discharge was derived. Inotrope score was calculated using the following formula:
Total inotrope score = Dopamine dose (µg/kg/min) + Dobutamine dose (µg/kg/min) + 10 * Milrinone dose (µg/kg/min) + 100 * Epinephrine dose (µg/kg/min) + 100 * Phenylephrine dose (µg/kg/min) + 100 * Norepinephrine dose (µg/kg/min).
Measured: Up to 48 hours after separation from CBP
Hemodynamic Improvement: Heart Rate
Heart rate at hours 1, 2, 4, 12, 24 and 48.
Measured: 2 Days
Hemodynamic Improvement: Systemic Arterial Blood Pressure
Systemic arterial blood pressure at hours 1, 2, 4, 12, 24 and 48.
Measured: 2 Days
Hemodynamic Improvement: Oxygen Saturation
Oxygen saturation at hours 1, 2, 4, 12, 24 and 48.
Measured: 2 Days
Hemodynamic Improvement: Central Venous Pressure
Central venous pressure at hours 1, 2, 4, 12, 24 and 48.
Measured: 2 Days
Thoracotomy Output
The thoracotomy output is defined as the total volume of chest tube drainage recorded in cc prior to discontinuation of chest intubation. The total postoperative duration (in hours) that the chest tube is used will be calculated as the time from the end of the surgery to the time the chest tube is removed. If an additional chest tube is required or reinserted (until discharge from the hospital or at Day 28) the duration that the additional chest tube was used (from time of insertion to time of removal) will be added to the time the original chest tube was used for the total postoperative duration. If a subject did not use any chest tube the duration is set to 0. As a sensitivity analysis, subjects with no use of chest tube will be excluded. For subjects who died before discharge from the hospital or before Day 28, respectively, the observed duration of chest tube drainage will be used.
Measured: 28 Days
Length of Time of Intubation
The length will be derived as the time in hours from separation from CPB until discontinuation of intubation. Any duration of re-use of intubation will continue to accrue. If a subject did not use any intubation the length is set to 0. As a sensitivity analysis, subjects with no use of intubations will be excluded. For subjects who died before discharge from the hospital or before Day 28, respectively, the observed length of time on intubation will be used. As sensitivity analyses subjects who died will (1) be excluded from analysis and (2) be assigned a length of time on intubation of 28 days.
For the length of time on intubation the same analyses as described for the primary endpoint will be applied.
Measured: 28 Days
Length of Pediatric Intensive Care Unit (PICU) Stay
The length of PICU stay will be calculated as the total number of days postoperative until discharge from PICU. For subjects who died before discharge from PICU or before Day 28, respectively, the observed length of PICU stay will be used. As sensitivity analyses subjects who died will (1) be excluded from analysis and (2) be assigned a length of PICU stay of 28 days. For the length of PICU stay the same analyses as described for the primary endpoint will be applied.
Measured: 28 Days
Length of Time on Vasodilators
Length of time on vasodilators will be measured from first use following separation from bypass, until the subject is discharged from the hospital or at Day 28. The length will be derived as the time in hours from separation from CPB until discontinuation of all vasodilators.
Measured: 28 Days
Length of Hospitalization
The length of hospitalization will be calculated as the total number of days postoperative until discharge from the hospital. For subjects who died before discharge from the hospital or before Day 28, respectively, the observed length of hospitalization will be used. As sensitivity analyses subjects who died will (1) be excluded from analysis and (2) be assigned a length of hospitalization of 28 days. The same analyses as described for the primary endpoint will be applied.
Measured: 28 Days
Patients With Plasma Concentrations of Citrulline
Plasma citrulline concentrations will be assessed in both treatment groups to determine the number of patients who reach the therapeutic sustained target plasma citrulline level of ≥100 μmol/L. Blood collection for assessment of plasma citrulline concentrations will be taken prior to surgery, during surgery, 30 minutes post-decannulation after CPB (prior to bolus and 5 minutes after bolus), at the specified post-operative time points (6h, 12h, 24h, 48h), and at hospital discharge or Day 28, whichever occurs first.
Measured: 28 Days
Occurrence of Adverse and Serious Adverse Events
Pre-treatment adverse events and treatment adverse events will be analyzed separately. The number of affected subjects will be reported.
Measured: 28 Days
Number of Patients With Refractory Hypotension
Refractory hypotension is defined as a 20% drop of mean arterial pressure (MAP) below specific age-related criteria for more than 30 minutes. The number of subjects with any refractory hypotension from end of surgery until 48 hours will be compared between groups.
Measured: 2 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2016 (estimated)
- Study startAug 2016
- Primary completionJun 2019
- Study completionJul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Acute Lung InjuryStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 189 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asklepion Pharmaceuticals, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gurdyal Kalsi, MD, Study director, Asklepion Pharmaceuticals, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02891837
- Sponsor's protocol ID
- CIT-003-01
- Other IDs
- 2016-002427-28, 2016
- Status last verified
- Jan 2023
- First submitted
- 23 Aug 2016
- Last updated
- 23 Feb 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2023. 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 Subjects Undergoing Surgery for Congenital Heart Defects
- ClinicalTrials.gov ID
- NCT02891837
- Acronym / sponsor ID
- CIT-003-01
- Conditions
- Acute Lung Injury
- Keywords
- L-citrulline, pediatric, Lung Injury, Bypass, Heart Defects, Clinical Sequelae
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 189 participants (actual)
- Lead sponsor
- Asklepion Pharmaceuticals, LLCIndustry (pharma, biotech, devices)
- Study start
- Aug 2016 (actual)
- Primary completion
- Jun 2019 (actual)
- Study completion
- Jul 2019 (actual)
- First posted
- 8 Sep 2016 (estimated)
- Results
- Posted 23 Feb 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 subjects undergoing surgery for congenital heart defects.
Eligible subjects 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 in this study.
Each enrolled subject will be randomized to receive either L-citrulline or placebo throughout all administrations in the study. Subjects will receive an L-citrulline bolus of 150 mg/kg or placebo at the initiation of cardiopulmonary bypass, the addition of L-citrulline at a concentration of 200 μmol/L or placebo 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. L-citrulline bolus of 20 mg/kg or placebo 30 minutes after decannulation from cardiopulmonary bypass, followed immediately by a 9 mg/kg/hr continuous L-citrulline infusion or placebo for up to 48 hours.
The study drug or placebo infusion will be discontinued once invasive arterial blood pressure monitoring is discontinued or at 48 hours, whichever comes first. Subjects will be followed until Day 28 or discharge from the hospital, whichever comes first. For subjects 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
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| L-citrulline | Experimental | Drug: 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. |
| Placebo | Placebo comparator | Other: 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. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- Evidence of pulmonary artery or vein abnormalities on the pre-operative echocardiogram that will not be addressed surgically. Specific abnormalities excluded include the following:
- 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)
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-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. | Drug | 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. | Other | Placebo |
Primary outcome
A Composite Variable Consisting of the Longer of Either (1) Length of Time on Mechanical Ventilation or (2) Length of Inotrope Use.
Time frame: 28 Days
Mechanical ventilation (MV) = invasive or noninvasive MV incl. bilevel (biphasic) positive airway pressure or continuous positive airway pressure. Inotrope use = medications considered within the derivation of total inotrope score (dopamine, dobutamine, milrinone, epinephrine, phenylephrine, norepinephrine). Both measures recorded until earliest of subject hospital discharge or Day 28.
16 secondary outcomes
Length of Time on Mechanical Ventilation
Time frame: 28 Days
Length of Time on Positive Pressure Ventilation
Time frame: 28 Days
Length of Time of Inotrope Use
Time frame: 28 days
Inotrope Score
Time frame: Up to 48 hours after separation from CBP
Hemodynamic Improvement: Heart Rate
Time frame: 2 Days
Hemodynamic Improvement: Systemic Arterial Blood Pressure
Time frame: 2 Days
Hemodynamic Improvement: Oxygen Saturation
Time frame: 2 Days
Hemodynamic Improvement: Central Venous Pressure
Time frame: 2 Days
Thoracotomy Output
Time frame: 28 Days
Length of Time of Intubation
Time frame: 28 Days
Length of Pediatric Intensive Care Unit (PICU) Stay
Time frame: 28 Days
Length of Time on Vasodilators
Time frame: 28 Days
Length of Hospitalization
Time frame: 28 Days
Patients With Plasma Concentrations of Citrulline
Time frame: 28 Days
Occurrence of Adverse and Serious Adverse Events
Time frame: 28 Days
Number of Patients With Refractory Hypotension
Time frame: 2 Days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Gurdyal Kalsi, MD study director
Asklepion Pharmaceuticals, LLC
29 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing L-citrulline in people with Acute Lung Injury, run by Asklepion Pharmaceuticals, LLC at 29 sites in 4 countries.
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: finished, as of the sponsor's last update on 23 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in United States, Germany, Israel, Austria. 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?
Yes. Results are posted in the registry (first posted 23 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
A Composite Variable Consisting of the Longer of Either (1) Length of Time on Mechanical Ventilation or (2) Length of Inotrope Use. (time frame: 28 Days). 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 23 Feb 2023.