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

Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05153525
• Other study ID #: 34409/1/21
• Status: Recruiting
• Phase: Phase 4
• Start date: January 6, 2022
• Est. completion date: August 5, 2022

Study information

• Verified date: June 2022
• Source: Tanta University
• Contact: Mohamed Khaled Talaat, PharmD
• Phone: 00201067967640
• Email: mohamedktalaat[@]pharm.tanta.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: August 5, 2022
• Est. primary completion date: July 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS)
• Lung Injury
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn
• Syndrome

Intervention

Drug:
• Intermittent boluses of Cisatracurium
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 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.

Locations

Country	Name	City	State
Egypt	Ain Shams University	Cairo
Egypt	Tanta University Hospitals	Tanta	Gharbia

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration on mechanical ventilation	Time from patient's intubation till extubation	Up to 10 days
Secondary	Length of pediatric intensive care unit stay	Time from start of ventilation till discharge from PICU	28 days
Secondary	Length of hospital stay	Time from start of ventilation till discharge from hospital	28 days
Secondary	Pediatric intensive care unit acquired weakness	Manual muscle strength testing (Oxford testing)	28 days
Secondary	Organ failure free days to day 28	Organ failure according to SOFA scores	28 days
Secondary	Ventilation follow-up	Oxygenation Index/Oxygen saturation index on study days 1, 3, 7	7 days
Secondary	28-day mortality	All children died after mechanical ventilation till day 28	28 days
Secondary	Serum Interleukin-8 assessment	Assessing serum interleukin 8 on admission and after 48 hours	48 hours
Secondary	Mechanical ventilation complications follow-up	Development of pneumothorax during mechanical ventilation	28 days