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

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

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

Study Overview

• Status: Unknown
• Conditions: COVID-19; ECMO
• Intervention / Treatment: Device: Low flow ECMO driving by CVVH machine

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100730
      • Recruiting
      • Yun Long
      • Contact: Yun Long; Phone Number: +8610169152300; Email: ly_icu@aliyun.com
      • Sub-Investigator: Xiang Zhou, MD
      • Sub-Investigator: Huaiwu He, MD
      • Sub-Investigator: Wei Cheng, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NCP patient with severe ARDS and/or high ventilator supported; The NCP patient with severe ARDS and/or high ventilator supported condition was eligibilitable for enrollment	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PaCO2	PaCO2 from blood gas analysis	Day 1
Driving Pressure	Driving Pressure monitor by ventilator	Day 1
Tidal volume	Tidal volume monitor by ventilator	Day 1

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital
• Investigators: Principal Investigator: Yun Long, Peking Union Medical College Hospit

Publications and helpful links

General Publications

• Ding X, Chen H, Zhao H, Zhang H, He H, Cheng W, Wang C, Jiang W, Ma J, Qin Y, Liu Z, Wang J, Yan X, Li T, Zhou X, Long Y, Zhang S. ECCO2R in 12 COVID-19 ARDS Patients With Extremely Low Compliance and Refractory Hypercapnia. Front Med (Lausanne). 2021 Jul 8;8:654658. doi: 10.3389/fmed.2021.654658. eCollection 2021.

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2020
• Primary Completion (Anticipated): August 15, 2020
• Study Completion (Anticipated): October 15, 2020

Study Registration Dates

• First Submitted: March 3, 2020
• First Submitted That Met QC Criteria: April 8, 2020
• First Posted (Actual): April 9, 2020

Study Record Updates

• Last Update Posted (Actual): June 16, 2020
• Last Update Submitted That Met QC Criteria: June 13, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: Low flow-ECMO by CVVH in NCP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No