Effect of Arterio-venous ECMO on Severe Sepsis and ARDS

Phase 1

Completed

• Conditions: Patients With Respiratory Failure and Shocked
• Interventions: Drug: Meropenem Injection; Device: A-V ECMO

• Registration Number: NCT04555798
• Lead Sponsor: Mohamed Gaber Allam

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2020-09-14
• Study First Submitted QC: 2020-09-14
• Study First Posted: 2020-09-21
• Study Start: 2022-02-01
• Primary Completion: 2022-02-01
• Study Completion: 2022-02-01
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-11
• Last Update Posted: 2022-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	Meropenem Injection	Group A continue on the same conventional way of management as mentioned above with conventional way of ventilation and broad spectrum antibiotics coverage
Group B	A-V ECMO	group B who connected to (A-VECMO).with venous access from femoral vien and arterial cannulation using the femoral artery
Group B	Meropenem Injection	group B who connected to (A-VECMO).with venous access from femoral vien and arterial cannulation using the femoral artery

Primary Outcome Measures

Name	Time	Method
number of patients weaned from ventilators	2 weeks	who showed improvement in CPIS score
number of patients disharged from ICU	2 weeks	who successfully weaned from the ventilator and complete 24 hours observation without symptoms

Trial Locations

Locations (1)

King abd el Aziz specialist hospital; 🇸🇦 Ta'if, Saudi Arabia