Effect of Arterio-venous ECMO on Severe Sepsis and ARDS

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-01

Study Completion Date

2022-02-01

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.

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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.

Conditions

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Patients With Respiratory Failure and Shocked

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

SCREENING

Blinding Strategy

SINGLE

Participants

Study Groups

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Group A

Group A continue on the same conventional way of management as mentioned above with conventional way of ventilation and broad spectrum antibiotics coverage

Group Type PLACEBO_COMPARATOR

Meropenem Injection

Intervention Type DRUG

patients of both groups given meropenam 1 gram every 8 hours till we collect the sputum culture

Group B

group B who connected to (A-VECMO).with venous access from femoral vien and arterial cannulation using the femoral artery

Group Type ACTIVE_COMPARATOR

Meropenem Injection

Intervention Type DRUG

patients of both groups given meropenam 1 gram every 8 hours till we collect the sputum culture

A-V ECMO

Intervention Type DEVICE

Only patients of group B connected to A-V ECMO for two weeks

Interventions

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Meropenem Injection

patients of both groups given meropenam 1 gram every 8 hours till we collect the sputum culture

Intervention Type DRUG

A-V ECMO

Only patients of group B connected to A-V ECMO for two weeks

Intervention Type DEVICE

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