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

Phase 4

• Conditions: Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS); Respiratory Distress Syndrome, Pediatric
• Interventions: Drug: Intermittent boluses of Cisatracurium; Drug: Intravenous infusion of Cisatracurium for 24 hours

• Registration Number: NCT05153525
• Lead Sponsor: Tanta University

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.

Study Timeline

• Study First Submitted: 2021-09-13
• Study First Submitted QC: 2021-12-09
• Study First Posted: 2021-12-10
• Study Start: 2022-01-06
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-20
• Last Update Posted: 2022-06-22
• Primary Completion: 2022-07-30
• Study Completion: 2022-08-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intermittent boluses group	Intermittent boluses of Cisatracurium	Thirty children with ARDS will be managed with intermittent boluses of Cisatracurium (0.1-0.15 mg/kg/dose).
Intravenous infusion for 24 hours	Intravenous 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.

Primary Outcome Measures

Name	Time	Method
Duration on mechanical ventilation	Up to 10 days	Time from patient's intubation till extubation

Secondary Outcome Measures

Name	Time	Method
Mechanical ventilation complications follow-up	28 days	Development of pneumothorax during mechanical ventilation
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
Pediatric intensive care unit acquired weakness	28 days	Manual muscle strength testing (Oxford testing)
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
28-day mortality	28 days	All children died after mechanical ventilation till day 28
Serum Interleukin-8 assessment	48 hours	Assessing serum interleukin 8 on admission and after 48 hours

Trial Locations

Locations (2)

Tanta University Hospitals; 🇪🇬 Tanta, Gharbia, Egypt

Ain Shams University; 🇪🇬 Cairo, Egypt