Respiratory Distress Syndrome, PediatricPhase 4NCT05153525
Continuous Infusion Versus Intermittent Boluses of Cisatracurium in the Early Management of Pediatric ARDS
A Phase 4 study testing Intermittent boluses of Cisatracurium and Intravenous infusion of Cisatracurium for 24 hours in people with Respiratory Distress Syndrome, Pediatric and Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS), run by Tanta University at 2 sites in Egypt.
Trial summary
The aim of this work is to compare continuous infusion vs on need intermittent boluses of Cisatracurium in the early management of pediatric acute respiratory distress syndrome Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Respiratory Distress Syndrome, Pediatric, Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS)
- What is being tested?
- Intermittent boluses of Cisatracurium and Intravenous infusion of Cisatracurium for 24 hours
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesEgypt
- Study dates
- 6 Jan 2022to 5 Aug 2022
- Phase
- Phase 4
- 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 1 month to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children with mild, moderate, and severe ARDS diagnosed according to criteria of Pediatric Acute Lung Injury Consensus Conference (PALICC) in 2015.
- Children of both sexes aged from one month to 18 years.
- Children diagnosed with ARDS <48 hours before enrollment
Who cannot join
- Continuous neuromuscular blockade at enrollment
- Children on phenytoin and carbamazepine
- Severe liver cirrhosis
- High-risk medical illness (Bone marrow transplantation within the last one-year, Diffuse alveolar hemorrhage from vasculitis, Chronic respiratory failure, Burns > 70% total body surface)
- Previous hypersensitivity or anaphylactic reaction to Cisatracurium
- Neuromuscular conditions that may potentiate neuromuscular blockade and/or impair effective spontaneous ventilation
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites, 2 recruiting
- Recruiting
Ain Shams University
Cairo
Hanan Ibrahim, MD, 00201001584662, hananibrahim5@hotmail.com
- Recruiting
Tanta University Hospitals
Tanta, Gharbia Governorate, 31511
Khaled T Muhammad, MD, 00201223472774, Khaledtalaat65@med.tanta.edu.eg
About this study
Official title: Continuous Infusion Versus Intermittent Boluses of Cisatracurium in the Early Management of Pediatric Acute Respiratory Distress Syndrome
The aim of this work is to compare continuous infusion vs on need intermittent boluses of Cisatracurium in the early management of pediatric acute respiratory distress syndrome
Read the detailed description
In the pediatric population, Acute respiratory distress syndrome (ARDS) has a high mortality rate of approximately 24%. In addition, there is a lack of high-quality data to guide the use of non-depolarizing neuromuscular blocking agents (NMBAs) in mechanically ventilated children. Hence, there is a need to evaluate its use in pediatrics.
- Conditions
- Respiratory Distress Syndrome, Pediatric, Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS)
- Being tested
- Intermittent boluses of Cisatracurium, Intravenous infusion of Cisatracurium for 24 hours
- Keywords
- Cisatracurium, PARDS
- Medical subject headings
- Respiratory Distress Syndrome, Acute Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent boluses of CisatracuriumDrug
Thirty children with ARDS will be treated with intermittent boluses of Cisatracurium (0.1-0.15 mg/kg/dose).
Intravenous infusion of Cisatracurium for 24 hoursDrug
Thirty children with ARDS will be treated with intravenous infusion of Cisatracurium titrated from 1 mic/kg/min till reaching the desired effect for 24 hours.
| Study group | Role | What they receive |
|---|---|---|
| Intermittent boluses group | Experimental | Thirty children with ARDS will be managed with intermittent boluses of Cisatracurium (0.1-0.15 mg/kg/dose). Receives: Drug: Intermittent boluses of Cisatracurium |
| Intravenous infusion for 24 hours | Experimental | Thirty children with ARDS will be treated with intravenous infusion of Cisatracurium titrated from 1 mic/kg/min till reaching the desired effect for 24 hours. Receives: Drug: Intravenous infusion of Cisatracurium for 24 hours |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration on mechanical ventilation
Time from patient's intubation till extubation
Measured: Up to 10 days
Secondary outcomes (8)
Length of pediatric intensive care unit stay
Time from start of ventilation till discharge from PICU
Measured: 28 days
Length of hospital stay
Time from start of ventilation till discharge from hospital
Measured: 28 days
Pediatric intensive care unit acquired weakness
Manual muscle strength testing (Oxford testing)
Measured: 28 days
Organ failure free days to day 28
Organ failure according to SOFA scores
Measured: 28 days
Ventilation follow-up
Oxygenation Index/Oxygen saturation index on study days 1, 3, 7
Measured: 7 days
28-day mortality
All children died after mechanical ventilation till day 28
Measured: 28 days
Serum Interleukin-8 assessment
Assessing serum interleukin 8 on admission and after 48 hours
Measured: 48 hours
Mechanical ventilation complications follow-up
Development of pneumothorax during mechanical ventilation
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2021
- Study start6 Jan 2022
- Primary completion30 Jul 2022 (estimated)
- Study completion5 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Distress Syndrome, PediatricStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Khaled Talaat, Tanta University
- Investigators
- Mohamed Khaled Talaat, PharmD, Principal investigator, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05153525
- Sponsor's protocol ID
- 34409/1/21
- Status last verified
- Jun 2022
- First submitted
- 13 Sep 2021
- Last updated
- 22 Jun 2022
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon reasonable request from the principal investigator
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Infusion Versus Intermittent Boluses of Cisatracurium in the Early Management of Pediatric Acute Respiratory Distress Syndrome
- ClinicalTrials.gov ID
- NCT05153525
- Acronym / sponsor ID
- 34409/1/21
- Conditions
- Respiratory Distress Syndrome, Pediatric, Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS)
- Keywords
- Cisatracurium, PARDS
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 6 Jan 2022 (actual)
- Primary completion
- 30 Jul 2022 (estimated)
- Study completion
- 5 Aug 2022 (estimated)
- First posted
- 10 Dec 2021 (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.
The aim of this work is to compare continuous infusion vs on need intermittent boluses of Cisatracurium in the early management of pediatric acute respiratory distress syndrome
Detailed description
In the pediatric population, Acute respiratory distress syndrome (ARDS) has a high mortality rate of approximately 24%. In addition, there is a lack of high-quality data to guide the use of non-depolarizing neuromuscular blocking agents (NMBAs) in mechanically ventilated children. Hence, there is a need to evaluate its use in pediatrics.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intermittent boluses group | Experimental | Drug: Intermittent boluses of CisatracuriumThirty children with ARDS will be managed with intermittent boluses of Cisatracurium (0.1-0.15 mg/kg/dose). |
| Intravenous infusion for 24 hours | Experimental | Drug: Intravenous infusion of Cisatracurium for 24 hoursThirty children with ARDS will be treated with intravenous infusion of Cisatracurium titrated from 1 mic/kg/min till reaching the desired effect for 24 hours. |
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Children with mild, moderate, and severe ARDS diagnosed according to criteria of Pediatric Acute Lung Injury Consensus Conference (PALICC) in 2015.
- Children of both sexes aged from one month to 18 years.
- Children diagnosed with ARDS <48 hours before enrollment
Key exclusion criteria (6 listed)
- Continuous neuromuscular blockade at enrollment
- Children on phenytoin and carbamazepine
- Severe liver cirrhosis
- High-risk medical illness (Bone marrow transplantation within the last one-year, Diffuse alveolar hemorrhage from vasculitis, Chronic respiratory failure, Burns > 70% total body surface)
- Previous hypersensitivity or anaphylactic reaction to Cisatracurium
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 |
|---|---|---|
| Intermittent boluses of CisatracuriumThirty children with ARDS will be treated with intermittent boluses of Cisatracurium (0.1-0.15 mg/kg/dose). | Drug | Intermittent boluses group |
| Intravenous infusion of Cisatracurium for 24 hoursThirty children with ARDS will be treated with intravenous infusion of Cisatracurium titrated from 1 mic/kg/min till reaching the desired effect for 24 hours. | Drug | Intravenous infusion for 24 hours |
Primary outcome
Duration on mechanical ventilation
Time frame: Up to 10 days
Time from patient's intubation till extubation
8 secondary outcomes
Length of pediatric intensive care unit stay
Time frame: 28 days
Length of hospital stay
Time frame: 28 days
Pediatric intensive care unit acquired weakness
Time frame: 28 days
Organ failure free days to day 28
Time frame: 28 days
Ventilation follow-up
Time frame: 7 days
28-day mortality
Time frame: 28 days
Serum Interleukin-8 assessment
Time frame: 48 hours
Mechanical ventilation complications follow-up
Time frame: 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2022.
- Individual participant dataSharing planned: Yes. The data will be available upon reasonable request from the principal investigator
Related trials for Respiratory Distress Syndrome, Pediatric
Recruiting
Amnioinfusion's Protective Effects on Respiratory and Longitudinal Pediatric Outcomes After Intrapartum Meconium Exposure
Neonatal Respiratory Distress Related Conditions, Meconium
RecruitingObservational study
Role of Dyspnea in the Progression of Pediatric Acute Respiratory Distress Syndrome
Pediatric Acute Respiratory Distress Syndrome (PARDS)
Not yet recruiting
AI-Guided Mechanical Ventilation in Children: A Randomized Controlled Trial
Acute Respiratory Distress Syndrome, Pneumonia in Children
Active, not recruitingObservational study
ARDS in Children and ECMO Initiation Strategies Impact on Neurodevelopment (ASCEND)
Acute Respiratory Distress Syndrome, Extracorporeal Membrane Oxygenation
RecruitingObservational study
Altitude and Outcomes in Pediatric ARDS: A Multicenter Study
Respiratory Distress Syndrome, Pediatric, Altitude Hypoxia
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.
Mohamed Khaled Talaat, PharmD principal investigator
Tanta University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Intermittent boluses of Cisatracurium and Intravenous infusion of Cisatracurium for 24 hours in people with Respiratory Distress Syndrome, Pediatric and Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS), run by Tanta University at 2 sites in Egypt.
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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 22 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed Khaled Talaat, PharmD (00201067967640, mohamedktalaat@pharm.tanta.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration on mechanical ventilation (time frame: Up to 10 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 22 Jun 2022.