Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS), Respiratory Distress Syndrome, Pediatric
Conditions
Keywords
Cisatracurium, PARDS
Brief 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
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.
Interventions
DRUGIntermittent boluses of Cisatracurium
Thirty children with ARDS will be treated with intermittent boluses of Cisatracurium (0.1-0.15 mg/kg/dose).
DRUGIntravenous infusion of Cisatracurium for 24 hours
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.
Sponsors
Tanta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Months to 18 Years
Healthy volunteers
No
Inclusion criteria
1. Children with mild, moderate, and severe ARDS diagnosed according to criteria of Pediatric Acute Lung Injury Consensus Conference (PALICC) in 2015. 2. Children of both sexes aged from one month to 18 years. 3. Children diagnosed with ARDS \<48 hours before enrollment
Exclusion criteria
1. Continuous neuromuscular blockade at enrollment 2. Children on phenytoin and carbamazepine 3. Severe liver cirrhosis 4. 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) 5. Previous hypersensitivity or anaphylactic reaction to Cisatracurium 6. Neuromuscular conditions that may potentiate neuromuscular blockade and/or impair effective spontaneous ventilation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration on mechanical ventilation | Up to 10 days | Time from patient's intubation till extubation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum Interleukin-8 assessment | 48 hours | Assessing serum interleukin 8 on admission and after 48 hours |
| Length of pediatric intensive care unit stay | 28 days | Time from start of ventilation till discharge from PICU |
| Length of hospital stay | 28 days | Time from start of ventilation till discharge from hospital |
| 28-day mortality | 28 days | All children died after mechanical ventilation till day 28 |
| Organ failure free days to day 28 | 28 days | Organ failure according to SOFA scores |
| Ventilation follow-up | 7 days | Oxygenation Index/Oxygen saturation index on study days 1, 3, 7 |
| Mechanical ventilation complications follow-up | 28 days | Development of pneumothorax during mechanical ventilation |
| Pediatric intensive care unit acquired weakness | 28 days | Manual muscle strength testing (Oxford testing) |
Countries
Egypt
Contacts
Primary ContactMohamed Khaled Talaat, PharmD
Outcome results
None listed