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

Primary Purpose

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

Status

Recruiting

Phase

Phase 4

Locations

Egypt

Study Type

Interventional

Intervention

Intermittent boluses of Cisatracurium

Intravenous infusion of Cisatracurium for 24 hours

About this trial

This is an interventional treatment trial for Respiratory Distress Syndrome, Pediatric focused on measuring Cisatracurium, PARDS

Eligibility Criteria

1 Month - 18 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

Tanta University HospitalsRecruiting
Ain Shams UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Intermittent boluses group

Intravenous infusion for 24 hours

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Duration on mechanical ventilation

Time from patient's intubation till extubation

Secondary Outcome Measures

Length of pediatric intensive care unit stay

Time from start of ventilation till discharge from PICU

Length of hospital stay

Time from start of ventilation till discharge from hospital

Pediatric intensive care unit acquired weakness

Manual muscle strength testing (Oxford testing)

Organ failure free days to day 28

Organ failure according to SOFA scores

Ventilation follow-up

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

28-day mortality

All children died after mechanical ventilation till day 28

Serum Interleukin-8 assessment

Assessing serum interleukin 8 on admission and after 48 hours

Mechanical ventilation complications follow-up

Development of pneumothorax during mechanical ventilation

Full Information

NCT ID

NCT05153525

First Posted

September 13, 2021

Last Updated

June 20, 2022

Sponsor

Tanta University

1. Study Identification

Unique Protocol Identification Number

NCT05153525

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2022

Overall Recruitment Status

Recruiting

Study Start Date

January 6, 2022 (Actual)

Primary Completion Date

July 30, 2022 (Anticipated)

Study Completion Date

August 5, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Tanta University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

5. 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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

Cisatracurium, PARDS

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Intermittent boluses group

Arm Type

Experimental

Arm Description

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

Arm Title

Intravenous infusion for 24 hours

Arm Type

Experimental

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

Intermittent boluses of Cisatracurium

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Intravenous infusion of Cisatracurium for 24 hours

Intervention Description

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.

Primary Outcome Measure Information:

Title

Duration on mechanical ventilation

Description

Time from patient's intubation till extubation

Time Frame

Up to 10 days

Secondary Outcome Measure Information:

Title

Length of pediatric intensive care unit stay

Description

Time from start of ventilation till discharge from PICU

Time Frame

28 days

Title

Length of hospital stay

Description

Time from start of ventilation till discharge from hospital

Time Frame

28 days

Title

Pediatric intensive care unit acquired weakness

Description

Manual muscle strength testing (Oxford testing)

Time Frame

28 days

Title

Organ failure free days to day 28

Description

Organ failure according to SOFA scores

Time Frame

28 days

Title

Ventilation follow-up

Description

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

Time Frame

7 days

Title

28-day mortality

Description

All children died after mechanical ventilation till day 28

Time Frame

28 days

Title

Serum Interleukin-8 assessment

Description

Assessing serum interleukin 8 on admission and after 48 hours

Time Frame

48 hours

Title

Mechanical ventilation complications follow-up

Description

Development of pneumothorax during mechanical ventilation

Time Frame

28 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

1 Month

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Mohamed Khaled Talaat, PharmD

Phone

00201067967640

mohamedktalaat@pharm.tanta.edu.eg

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mohamed Khaled Talaat, PharmD

Organizational Affiliation

Tanta University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Tanta University Hospitals

City

Tanta

State/Province

Gharbia

ZIP/Postal Code

31511

Country

Egypt

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Khaled T Muhammad, MD

Phone

00201223472774

Khaledtalaat65@med.tanta.edu.eg

Facility Name

Ain Shams University

City

Cairo

Country

Egypt

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Hanan Ibrahim, MD

Phone

00201001584662

hananibrahim5@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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

Learn more about this trial

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

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