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NCT04340414 Clinical Trial

Safety and Effectiveness of Low-flow ECMO Driving by CVVH Machine in Severe NCP

COVID-19 Clinical Trial

Official title:
Safety and Effectiveness Study of Low Flow Extracorporeal Membrane Oxygenation（CO2 Removal） Driving by Continuous Hemofiltration Machine the Severe New Corovirus Pneumonia (NCP)

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04340414
Other study ID # Low flow-ECMO by CVVH in NCP
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 20, 2020
Est. completion date October 15, 2020

Study information
Verified date June 2020
Source Peking Union Medical College Hospital
Contact Yun Long, MD
Phone +8610169152300
Email ly_icu@aliyun.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

assess the safety and effectiveness of using low-flow extracorporeal membrane oxygenation(CO2 removal) driving by CVVH machine in the severe NCP patients

Recruitment information / eligibility
Status Recruiting
Enrollment 10
Est. completion date October 15, 2020
Est. primary completion date August 15, 2020
Accepts healthy volunteers No
Gender All
Age group 14 Years and older
Eligibility Inclusion Criteria:

- 1. NCP with severe acute respiratory distress syndrome with ratio of partial pressure of arterial oxygen over fraction of inspired oxygen (PaO2:FiO2)<150 and PEEP >10cmH2O

- 2. Driving pressure> 20cmH2O

- 3. RR>30bpm

- 4.PaCO2>55cmH2O and/or PH>7.3

Exclusion Criteria:

- 1. poor venous vascular condition and unavaible for central venous catheter placement

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Low flow ECMO driving by CVVH machine
With aim to clear CO2 and improve oxygenation, a low flow ECMO treatment(using oxgyenator membrane of kid type ) driving by CVVH machine will be performed in the NCP with severe ARDS

Locations
Country Name City State
China Yun Long Beijing Beijing

Sponsors (1)
Lead Sponsor Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary PaCO2 PaCO2 from blood gas analysis Day 1
Primary Driving Pressure Driving Pressure monitor by ventilator Day 1
Primary Tidal volume Tidal volume monitor by ventilator Day 1
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