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

Sponsor

Tanta University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05153525

Collaborator

(none)

Enrollment

Locations

Arms

6.9

Anticipated Duration (Months)

Patients Per Site

4.3

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Respiratory Distress Syndrome, Pediatric Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS)	Drug: Intermittent boluses of Cisatracurium Drug: Intravenous infusion of Cisatracurium for 24 hours	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 6, 2022

Anticipated Primary Completion Date :

Jul 30, 2022

Anticipated Study Completion Date :

Aug 5, 2022

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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
Mechanical ventilation complications follow-up [28 days]
Development of pneumothorax during mechanical ventilation

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Month to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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