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Completed

NCT Number: NCT04555798

Effect of Arterio-venous ECMO on Severe Sepsis and ARDS

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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Key information

Conditions

Patients With Respiratory Failure and Shocked Pathologic Processes Pathological Conditions, Signs and Symptoms Shock

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

King abd el Aziz specialist hospital

Ta'if, 21944, Saudi Arabia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Meropenem Injection

Drug

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

A-V ECMO

Device

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

Primary outcomes

  1. number of patients weaned from ventilators

    Time frame: 2 weeks

    who showed improvement in CPIS score

  2. number of patients disharged from ICU

    Time frame: 2 weeks

    who successfully weaned from the ventilator and complete 24 hours observation without symptoms

Sponsors and collaborators

Lead sponsor

Mohamed Gaber Allam

Network

Collaborators

  • King Abdul Aziz Specialist Hospital

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Sep 21, 2020
Registry last updated
Apr 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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