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

NCT05153525 | Unknown Phase 4 FDA Drug

• 1 other identifier: 34409/1/21
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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

Conditions

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

Keywords

Cisatracurium; PARDS

Outcome Measures

Primary Outcomes (1)

• Duration on mechanical ventilation

  Time from patient's intubation till extubation

  Up to 10 days

Secondary Outcomes (8)

• Length of pediatric intensive care unit stay

  28 days

• Length of hospital stay

  28 days

• Pediatric intensive care unit acquired weakness

  28 days

• Organ failure free days to day 28

  28 days

• Ventilation follow-up

  7 days

Study Arms (2)

Intermittent boluses group

EXPERIMENTAL

Thirty children with ARDS will be managed with intermittent boluses of Cisatracurium (0.1-0.15 mg/kg/dose).

Drug: Intermittent boluses of Cisatracurium

Intravenous infusion for 24 hours

EXPERIMENTAL

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

Interventions

Intermittent boluses of Cisatracurium DRUG

Thirty children with ARDS will be treated with intermittent boluses of Cisatracurium (0.1-0.15 mg/kg/dose).

Intermittent boluses group

Intravenous infusion of Cisatracurium for 24 hours DRUG

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.

Intravenous infusion for 24 hours

Eligibility Criteria

• Age: 1 Month - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Children with mild, moderate, and severe ARDS diagnosed according to criteria of Pediatric Acute Lung Injury Consensus Conference (PALICC) in 2015.
• Children of both sexes aged from one month to 18 years.
• Children diagnosed with ARDS \<48 hours before enrollment

You may not qualify if:

• Continuous neuromuscular blockade at enrollment
• Children on phenytoin and carbamazepine
• Severe liver cirrhosis
• 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)
• Previous hypersensitivity or anaphylactic reaction to Cisatracurium
• Neuromuscular conditions that may potentiate neuromuscular blockade and/or impair effective spontaneous ventilation

Sponsors & Collaborators

• Tanta University: lead

Study Sites (2)

Tanta University Hospitals

Tanta, Gharbia Governorate, 31511, Egypt

RECRUITING

Ain Shams University

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Respiratory Distress Syndrome; Acute Lung Injury

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Lung Injury

Study Officials

• Mohamed Khaled Talaat, PharmD

  Tanta University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohamed Khaled Talaat, PharmD

CONTACT

00201067967640; mohamedktalaat@pharm.tanta.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 13, 2021
• First Posted: December 10, 2021
• Study Start: January 6, 2022
• Primary Completion: July 30, 2022
• Study Completion: August 5, 2022
• Last Updated: June 22, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: for one year after completion of the study

Locations

EG (2)