Effect of Arterio-venous ECMO on Severe Sepsis and ARDS

NCT04555798 | Completed Phase 1 DMC FDA Drug FDA Device

• 1 other identifier: ICU-44-20
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Patients With Respiratory Failure and Shocked

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

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

Meropenem Injection DRUG

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

Group A; Group B

A-V ECMO DEVICE

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

Group B

Eligibility Criteria

• Age: 18 Years - 65 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• pediatric patients below 18 years of age

Sponsors & Collaborators

• Mohamed Gaber Allam: lead
• King Abdul Aziz Specialist Hospital: collaborator

Study Sites (1)

King abd el Aziz specialist hospital

Ta'if, 21944, Saudi Arabia

Location

MeSH Terms

Conditions

Shock

Interventions

Meropenem

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thienamycins; Carbapenems; beta-Lactams; Lactams; Amides; Organic Chemicals; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Consultant intensivist

Model Details: 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

Study Record Dates

• First Submitted: September 14, 2020
• First Posted: September 21, 2020
• Study Start: February 1, 2022
• Primary Completion: February 1, 2022
• Study Completion: February 1, 2022
• Last Updated: April 12, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)