Continuous Infusion Versus Intermittent Boluses of Cisatracurium in the Early Management of Pediatric ARDS

Study Overview
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Brief Summary
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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
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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.

Official Title
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Continuous Infusion Versus Intermittent Boluses of Cisatracurium in the Early Management of Pediatric Acute Respiratory Distress Syndrome

Conditions
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Respiratory Distress Syndrome, Pediatric, Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS)

Intervention / Treatment
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* Drug: Intermittent boluses of Cisatracurium
* Drug: Intravenous infusion of Cisatracurium for 24 hours


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intermittent boluses group<br>Thirty children with ARDS will be managed with intermittent boluses of Cisatracurium (0.1-0.15 mg/kg/dose). | Drug: Intermittent boluses of Cisatracurium<br>* Thirty children with ARDS will be treated with intermittent boluses of Cisatracurium (0.1-0.15 mg/kg/dose).<br>|
| Experimental: Intravenous infusion for 24 hours<br>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. | Drug: Intravenous infusion of Cisatracurium for 24 hours<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration on mechanical ventilation | Time from patient's intubation till extubation | Up to 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of pediatric intensive care unit stay | Time from start of ventilation till discharge from PICU | 28 days | 
| Length of hospital stay | Time from start of ventilation till discharge from hospital | 28 days | 
| Pediatric intensive care unit acquired weakness | Manual muscle strength testing (Oxford testing) | 28 days | 
| Organ failure free days to day 28 | Organ failure according to SOFA scores | 28 days | 
| Ventilation follow-up | Oxygenation Index/Oxygen saturation index on study days 1, 3, 7 | 7 days | 
| 28-day mortality | All children died after mechanical ventilation till day 28 | 28 days | 
| Serum Interleukin-8 assessment | Assessing serum interleukin 8 on admission and after 48 hours | 48 hours | 
| Mechanical ventilation complications follow-up | Development of pneumothorax during mechanical ventilation | 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cisatracurium, PARDS