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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intermittent boluses group | Experimental | Thirty children with ARDS will be managed with intermittent boluses of Cisatracurium (0.1-0.15 mg/kg/dose). |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intermittent boluses of Cisatracurium | Drug | Thirty children with ARDS will be treated with intermittent boluses of Cisatracurium (0.1-0.15 mg/kg/dose). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Duration on mechanical ventilation | Time from patient's intubation till extubation | Up to 10 days |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mohamed Khaled Talaat, PharmD | Contact | 00201067967640 | mohamedktalaat@pharm.tanta.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Mohamed Khaled Talaat, PharmD | Tanta University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tanta University Hospitals | Recruiting | Tanta | Gharbia Governorate | 31511 | Egypt |
The data will be available upon reasonable request from the principal investigator
for one year after completion of the study
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| 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. |
|
| 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 |
| Ain Shams University | Recruiting | Cairo | Egypt |
|
| ID | Term |
|---|---|
| D012128 | Respiratory Distress Syndrome |
| D055371 | Acute Lung Injury |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
| D055370 | Lung Injury |
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