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

Tanta University60 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

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

Interventions

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.

Eligibility

Sex: ALLMin age: 1 MonthMax age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Tanta University Hospitals

Tanta, Gharbia Governorate, Egypt

RECRUITING

Ain Shams University

Cairo, Egypt

RECRUITING

Outcomes

Primary Outcomes

Duration on mechanical ventilation

Time from patient's intubation till extubation

Time frame: Up to 10 days

Secondary Outcomes

Length of pediatric intensive care unit stay

Time from start of ventilation till discharge from PICU

Time frame: 28 days

Length of hospital stay

Time from start of ventilation till discharge from hospital

Time frame: 28 days

Pediatric intensive care unit acquired weakness

Manual muscle strength testing (Oxford testing)

Time frame: 28 days

Organ failure free days to day 28

Organ failure according to SOFA scores

Time frame: 28 days

Ventilation follow-up

Oxygenation Index/Oxygen saturation index on study days 1, 3, 7

Time frame: 7 days

28-day mortality

All children died after mechanical ventilation till day 28

Time frame: 28 days

Serum Interleukin-8 assessment

Assessing serum interleukin 8 on admission and after 48 hours

Time frame: 48 hours

Mechanical ventilation complications follow-up

Development of pneumothorax during mechanical ventilation

Central Contacts

Mohamed Khaled Talaat, PharmD

CONTACT

00201067967640 mohamedktalaat@pharm.tanta.edu.eg

Data from ClinicalTrials.gov

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