Effect of Arterio-venous ECMO on Severe Sepsis and ARDS

Mohamed Gaber Allam

Status and phase: Completed; Phase 2; Phase 1

Conditions: Patients With Respiratory Failure and Shocked

Treatments: Device: A-V ECMO; Drug: Meropenem Injection

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT04555798

ICU-44-20

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 100 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups, including a placebo group

Group A

Placebo Comparator group

Description:

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

Treatment:

Drug: Meropenem Injection

Group B

Active Comparator group

Description:

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

Treatment:

Device: A-V ECMO

Drug: Meropenem Injection