Effect of Arterio-venous ECMO on Severe Sepsis and ARDS

Study Overview
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Brief Summary
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To evaluate and compare the effect of immunoadsorption effect of A-V ECMO on course of sepsis weaning from inotropes, weaning from the ventilator, duration of ICU stays and effect on mortality rate in patients with septic shock and respiratory failure due to ARDS followed severe lung contusion.

Detailed Description
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100 patients with respiratory failure without improvement after 10 days ventilation due to development of VAP with ARDS, had >2 SOFA score and >6 CPIS score included in two groups 50 patients in each. Only patients of group B put on A-V ECMO while patients of group A continue on traditional way of management. Improvement of ARDS &VAP, weaning from ventilation, duration of ICU stays, improvement of one/all parameters of both SOFA and CPIS scores, morbidity and mortality recorded and compared within 14 days.

Official Title
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The Immunoadsorption Effect of Arterio-venous ECMO in Refractory Septic Shock With ARDS Following Severe Lung Contusion

Conditions
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Patients With Respiratory Failure and Shocked

Intervention / Treatment
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* Drug: Meropenem Injection
* Device: A-V ECMO


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Those who had an age between 18-65 years old patients ventilated for more than 10 days with conscious level more than 8/15 on Glasgow Coma Scale Exclusion Criteria: pediatric patients below 18 years of age

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 100 patients from those who showed no improvement after 10 days ventilation and still had respiratory failure and in need of high ventilatory parameters (as mentioned before), fulfilled > 2 parameters on SOFA score as illustrated in table (2), > 6 on CPIS score as illustrated in table (3) and developed circulatory failure (septic shock) with nor-adrenaline infusion and only on high dose of nor-adrenaline included in our study (>5microgram/kg/minute intravenous infusion as circulatory support). Since the parameters of those 100 patients selected are considered indication for arteriovenous extracorporeal membranous (A-V ECMO), so patients randomly allocated in two groups 50 patients in each. Randomization sequence was created using Excel 2007 (Microsoft, Redmond, WA, USA) with a 1:1 allocation using random block sizes of 2 and 4 by an independent doctor. In this way, sequence generation and type of randomization can be expressed at the same time
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Group A<br>Group A continue on the same conventional way of management as mentioned above with conventional way of ventilation and broad spectrum antibiotics coverage | Drug: Meropenem Injection<br>* patients of both groups given meropenam 1 gram every 8 hours till we collect the sputum culture<br>|
| Active Comparator: Group B<br>group B who connected to (A-VECMO).with venous access from femoral vien and arterial cannulation using the femoral artery | Drug: Meropenem Injection<br>* patients of both groups given meropenam 1 gram every 8 hours till we collect the sputum culture<br>Device: A-V ECMO<br>* Only patients of group B connected to A-V ECMO for two weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of patients weaned from ventilators | who showed improvement in CPIS score | 2 weeks | 
| number of patients disharged from ICU | who successfully weaned from the ventilator and complete 24 hours observation without symptoms | 2 weeks |