Effect of Arterio-venous ECMO on Severe Sepsis and ARDS
Primary Purpose
Patients With Respiratory Failure and Shocked
Status
Completed
Phase
Phase 1
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Meropenem Injection
A-V ECMO
Sponsored by
About this trial
This is an interventional screening trial for Patients With Respiratory Failure and Shocked
Eligibility Criteria
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
Sites / Locations
- King abd el Aziz specialist hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Group A
Group B
Arm Description
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 who connected to (A-VECMO).with venous access from femoral vien and arterial cannulation using the femoral artery
Outcomes
Primary Outcome Measures
number of patients weaned from ventilators
who showed improvement in CPIS score
number of patients disharged from ICU
who successfully weaned from the ventilator and complete 24 hours observation without symptoms
Secondary Outcome Measures
Full Information
NCT ID
NCT04555798
First Posted
September 14, 2020
Last Updated
April 11, 2022
Sponsor
Mohamed Gaber Allam
Collaborators
King Abdul Aziz Specialist Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04555798
Brief Title
Effect of Arterio-venous ECMO on Severe Sepsis and ARDS
Official Title
The Immunoadsorption Effect of Arterio-venous ECMO in Refractory Septic Shock With ARDS Following Severe Lung Contusion
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
February 1, 2022 (Actual)
Primary Completion Date
February 1, 2022 (Actual)
Study Completion Date
February 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Mohamed Gaber Allam
Collaborators
King Abdul Aziz Specialist Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patients With Respiratory Failure and Shocked
7. Study Design
Primary Purpose
Screening
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Model Description
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
Masking
Participant
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Placebo Comparator
Arm Description
Group A continue on the same conventional way of management as mentioned above with conventional way of ventilation and broad spectrum antibiotics coverage
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
group B who connected to (A-VECMO).with venous access from femoral vien and arterial cannulation using the femoral artery
Intervention Type
Drug
Intervention Name(s)
Meropenem Injection
Intervention Description
patients of both groups given meropenam 1 gram every 8 hours till we collect the sputum culture
Intervention Type
Device
Intervention Name(s)
A-V ECMO
Intervention Description
Only patients of group B connected to A-V ECMO for two weeks
Primary Outcome Measure Information:
Title
number of patients weaned from ventilators
Description
who showed improvement in CPIS score
Time Frame
2 weeks
Title
number of patients disharged from ICU
Description
who successfully weaned from the ventilator and complete 24 hours observation without symptoms
Time Frame
2 weeks
10. Eligibility
Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
King abd el Aziz specialist hospital
City
Ta'if
ZIP/Postal Code
21944
Country
Saudi Arabia
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
only after publishing the work in specific journal
Learn more about this trial
Effect of Arterio-venous ECMO on Severe Sepsis and ARDS
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