Patients With Respiratory Failure and Shocked
Conditions
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.
Interventions
patients of both groups given meropenam 1 gram every 8 hours till we collect the sputum culture
DEVICEA-V ECMO
Only patients of group B connected to A-V ECMO for two weeks
Sponsors
King Abdul Aziz Specialist Hospital
Mohamed Gaber Allam
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
SINGLE (Subject)
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
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| number of patients weaned from ventilators | 2 weeks | who showed improvement in CPIS score |
| number of patients disharged from ICU | 2 weeks | who successfully weaned from the ventilator and complete 24 hours observation without symptoms |
Countries
Saudi Arabia
Outcome results
None listed