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

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

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

Study Overview

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

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Mohamed Khaled Talaat, PharmD; Phone Number: 00201067967640; Email: mohamedktalaat@pharm.tanta.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • ain shams University
    • Contact: Hanan Ibrahim, MD; Phone Number: 00201001584662; Email: hananibrahim5@hotmail.com
  • Gharbia
    • Tanta, Gharbia, Egypt, 31511
      • Recruiting
      • Tanta University hospitals
      • Contact: Khaled T Muhammad, MD; Phone Number: 00201223472774; Email: Khaledtalaat65@med.tanta.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intermittent boluses group; Thirty children with ARDS will be managed with intermittent boluses of Cisatracurium (0.1-0.15 mg/kg/dose).	Drug: Intermittent boluses of Cisatracurium; Thirty children with ARDS will be treated with intermittent boluses of Cisatracurium (0.1-0.15 mg/kg/dose).
Experimental: Intravenous infusion 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.	Drug: 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Tanta University
• Investigators: Principal Investigator: Mohamed Khaled Talaat, PharmD, Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2022
• Primary Completion (Anticipated): July 30, 2022
• Study Completion (Anticipated): August 5, 2022

Study Registration Dates

• First Submitted: September 13, 2021
• First Submitted That Met QC Criteria: December 9, 2021
• First Posted (Actual): December 10, 2021

Study Record Updates

• Last Update Posted (Actual): June 22, 2022
• Last Update Submitted That Met QC Criteria: June 20, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Cisatracurium; PARDS
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Wounds and Injuries; Disease; Infant, Newborn, Diseases; Infant, Premature, Diseases; Thoracic Injuries; Syndrome; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury; Lung Injury; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Cholinergic Antagonists; Cholinergic Agents; Neuromuscular Agents; Nicotinic Antagonists; Neuromuscular Nondepolarizing Agents; Neuromuscular Blocking Agents; Cisatracurium; Atracurium
• Other Study ID Numbers: 34409/1/21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon reasonable request from the principal investigator
• IPD Sharing Time Frame: for one year after completion of the study
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes