Effect of Arterio-venous ECMO on Severe Sepsis and ARDS | NCT04555798

Studies
Effect of Arterio-venous ECMO on Severe Sepsis and ARDS

NCT04555798

Sponsor

Mohamed Gaber Allam

Status

Completed

Last Update Posted

Apr 12, 2022Actual

Enrollment

100Actual

Phase

Phase 1Phase 2

Conditions

Patients With Respiratory Failure and Shocked

Interventions

Meropenem Injection
A-V ECMO

Countries

Saudi Arabia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2022Actual

Primary Completion Date

Feb 1, 2022Actual

Completion Date

Feb 1, 2022Actual

First Submitted Date

Sep 14, 2020

First Submission Date that Met QC Criteria

Sep 14, 2020

First Posted Date

Sep 21, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 11, 2022

Last Update Posted Date

Apr 12, 2022Actual

Name	Class
King Abdul Aziz Specialist Hospital	NETWORK

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Yes

Is Unapproved Device

Yes

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group A	Placebo Comparator	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
Group B	Active Comparator	group B who connected to (A-VECMO).with venous access from femoral vien and arterial cannulation using the femoral artery	Drug: Meropenem Injection Device: A-V ECMO

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Meropenem Injection	Drug	patients of both groups given meropenam 1 gram every 8 hours till we collect the sputum culture	Group A Group B

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
King abd el Aziz specialist hospital		Ta'if		21944	Saudi Arabia

IPD Sharing Statement Module

Plan to Share IPD

Description

only after publishing the work in specific journal

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012769	Shock

Ancestor Terms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077731	Meropenem

Ancestor Terms

ID	Term
D013845	Thienamycins
D015780	Carbapenems
D047090	beta-Lactams
D007769	Lactams
D000577

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention 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