Effect of Arterio-venous ECMO on Severe Sepsis and ARDS

Patients With Respiratory Failure and Shocked Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04555798
• Other study ID #: ICU-44-20
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: February 1, 2022
• Est. completion date: February 1, 2022

Study information

• Verified date: April 2022
• Source: King Abdul Aziz Specialist Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: February 1, 2022
• Est. primary completion date: February 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Patients With Respiratory Failure and Shocked
• Respiratory Insufficiency

Intervention

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

Locations

Country	Name	City	State
Saudi Arabia	King abd el Aziz specialist hospital	Ta'if

Sponsors (2)

Lead Sponsor	Collaborator
Mohamed Gaber Allam	King Abdul Aziz Specialist Hospital

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

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