Effect of Arterio-venous ECMO on Severe Sepsis and ARDS

April 11, 2022 updated by: Mohamed Gaber Allam

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Saudi Arabia
      • Ta'if, Saudi Arabia, 21944
        • King abd el Aziz specialist hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SCREENING
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: 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
Drug: Meropenem Injection
patients of both groups given meropenam 1 gram every 8 hours till we collect the sputum culture
ACTIVE_COMPARATOR: Group B
group B who connected to (A-VECMO).with venous access from femoral vien and arterial cannulation using the femoral artery
Drug: Meropenem Injection
patients of both groups given meropenam 1 gram every 8 hours till we collect the sputum culture
Device: A-V ECMO
Only patients of group B connected to A-V ECMO for two weeks

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mohamed Gaber Allam

Collaborators

King Abdul Aziz Specialist Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 1, 2022

Primary Completion (ACTUAL)

February 1, 2022

Study Completion (ACTUAL)

February 1, 2022

Study Registration Dates

First Submitted

September 14, 2020

First Submitted That Met QC Criteria

September 14, 2020

First Posted (ACTUAL)

September 21, 2020

Study Record Updates

Last Update Posted (ACTUAL)

April 12, 2022

Last Update Submitted That Met QC Criteria

April 11, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ICU-44-20

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

only after publishing the work in specific journal

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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