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The Effect of Erythropoietin on Alveolar Fluid Clearance in Patients With Acute Respiratory Distress Syndrome

Primary Purpose

Acute Respiratory Distress Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Human erythropoietin injection
0.9%NaCl
Sponsored by
Second Affiliated Hospital of Wenzhou Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Respiratory Distress Syndrome focused on measuring Erythropoietin, ARDS, Lung Water Clearance

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age≥18 years; Meeting diagnostic criteria for sepsis 3.0; Tracheal intubation and mechanical ventilation; Meeting the diagnostic criteria of ARDS Berlin; Willing to accept treatment and sign an informed consent form; Exclusion Criteria: Age <18 years; Pregnancy or lactation; Patients with malignant tumors; Recombinant human erythropoietin (rhEPO) allergic patients; Hemoglobin (Hb) ≥120g/L; have recently taken rhEPO (within 3 months) or participated in other clinical trials; History of thromboembolic disease (pulmonary embolism, heart attack, cerebral infarction, arteriovenous thrombosis); Inability or unwillingness to provide informed consent or to comply with the requirements of the study;

Sites / Locations

  • SAHWenzhouMURecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Erythropoietin group

0.9%NS

Arm Description

intravenous injection of 40000iu of rhEPO

intravenous injection of the same volume of 0.9%NS as the test group

Outcomes

Primary Outcome Measures

EVLWI
extravascular lung water index
PVPI
pulmonary vascular permeability index

Secondary Outcome Measures

Survival rate
28-day survival rate
Oxygenation index
PaO2/FiO2

Full Information

First Posted
April 24, 2023
Last Updated
May 4, 2023
Sponsor
Second Affiliated Hospital of Wenzhou Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05857891
Brief Title
The Effect of Erythropoietin on Alveolar Fluid Clearance in Patients With Acute Respiratory Distress Syndrome
Official Title
The Effect of Erythropoietin on Alveolar Fluid Clearance in Patients With Acute Respiratory Distress Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 20, 2023 (Anticipated)
Primary Completion Date
October 31, 2026 (Anticipated)
Study Completion Date
March 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital of Wenzhou Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Acute respiratory distress syndrome (ARDS) is a common acute and critical disease in clinic. The clinical mortality is as high as 30%-40%. At present, there is no specific treatment. Erythropoietin (EPO), also known as erythrocyte- stimulating factor, erythropoietin, has a certain amount in normal human body, mainly synthesized by liver in infants and kidneys in adults, which can stimulate erythropoiesis. In recent years, more and more studies have shown that high-dose exogenous EPO administration has benefit effects on multi-organ protection. Therefore, we designed this prospective, double-blind, placebo-controlled trial for defecting EPO on the alveolar fluid clearance of ARDS. The study mainly answers the following questions: Does human erythropoietin accelerate the resolution of alveolar edema in ARDS? Is there any effect on hospital survival? The study will draw conclusions by comparing the control group with the experimental group.
Detailed Description
This study was designed as a double-blind, randomized controlled trial. Neither the subject nor the investigator knew the allocation of treatment drugs. Subjects signed the informed consent form, completed all screening assessments, and were randomized in the order of screening eligibility after screening eligibility. The investigator or designee generated the corresponding case number and drug number using a simple randomization method. Information about the subject's trial product allocation was placed in an emergency envelope and retained by the investigator for use in an emergency. Randomised subjects who withdraw from the clinical trial for any reason, regardless of whether they have taken the trial medication, will retain their case number and medication number and will not be allowed to re-enter the trial. The investigator participating in this trial is a clinician with appropriate experience, who can make treatment decision based on the clinical response and laboratory test results of the subject. The specific process of the study is as follows: The subjects of this study were patients with ARDS admitted to ICU. After signing the informed consent form, complete medical history collection, vital signs and detailed physical examination will be performed. Patients meeting the inclusion criteria but not meeting the exclusion criteria will be randomized into the study. Patients with ARDS who met the inclusion criteria were connected to PiCCO, randomly assigned to the following two groups, and monitored continuously for 3 days. Group A: Erythropoietin, 40000 IU, single intravenous injection. Group B: 0.9%NaCl group, with the same volume as group A, single intravenous injection. The baseline values of extravascular lung water index (EVLWI) and pulmonary vascular permeability index (PVPI) were monitored by PiCCO after recording the general conditions of the subjects included in the study before intervention. After EPO or 0.9% NaCl intervention, EVLWI and PVPI at 0, 6, 12, 24, 48 and 72h after EPO or normal saline administration, and blood gas analysis, CRP, PCT, blood routine, inflammatory factors (TNF-a,IL-6,IL-8,IL-1β), endothelial cell injury marker (s-ICAM-1), alveolar epithelial cell injury marker (sRAGE,SP-D) and other laboratory indicators and clinical indicators such as peak airway pressure, mean airway pressure and positive end-expiratory pressure (PEEP) at 0, 1, 2 and 3 days after administration were recorded. The hospital survival rate and 28-day survival rate were compared between the experimental group and the control group.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Distress Syndrome
Keywords
Erythropoietin, ARDS, Lung Water Clearance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Erythropoietin group
Arm Type
Experimental
Arm Description
intravenous injection of 40000iu of rhEPO
Arm Title
0.9%NS
Arm Type
Placebo Comparator
Arm Description
intravenous injection of the same volume of 0.9%NS as the test group
Intervention Type
Drug
Intervention Name(s)
Human erythropoietin injection
Other Intervention Name(s)
Treatment measures taken according to the patient's condition
Intervention Description
Each subject in the test group received 40000iu of human erythropoietin intravenously
Intervention Type
Drug
Intervention Name(s)
0.9%NaCl
Other Intervention Name(s)
Treatment measures taken according to the patient's condition
Intervention Description
Each subject in the control group was injected with an equal volume of 0.9%NaCl
Primary Outcome Measure Information:
Title
EVLWI
Description
extravascular lung water index
Time Frame
Changes of EVLWI at 0,6,12,24 ,48 and 72 hours after intervention
Title
PVPI
Description
pulmonary vascular permeability index
Time Frame
Changes of PVPI at 0,6,12,24 ,48 and 72 hours after intervention
Secondary Outcome Measure Information:
Title
Survival rate
Description
28-day survival rate
Time Frame
28-day hospital survival
Title
Oxygenation index
Description
PaO2/FiO2
Time Frame
Changes of oxygenation index at 0, 1, 2 and 3 days after intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age≥18 years; Meeting diagnostic criteria for sepsis 3.0; Tracheal intubation and mechanical ventilation; Meeting the diagnostic criteria of ARDS Berlin; Willing to accept treatment and sign an informed consent form; Exclusion Criteria: Age <18 years; Pregnancy or lactation; Patients with malignant tumors; Recombinant human erythropoietin (rhEPO) allergic patients; Hemoglobin (Hb) ≥120g/L; have recently taken rhEPO (within 3 months) or participated in other clinical trials; History of thromboembolic disease (pulmonary embolism, heart attack, cerebral infarction, arteriovenous thrombosis); Inability or unwillingness to provide informed consent or to comply with the requirements of the study;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shengwei Jin, Professor
Phone
13616663961
Email
jinshengwei69@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yuqiang Gong, Professor
Phone
13858785608
Email
gyq12120@163.com@163
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ye Gao, PhD
Organizational Affiliation
Second Affiliated Hospital of Wenzhou Medical University
Official's Role
Study Director
Facility Information:
Facility Name
SAHWenzhouMU
City
Wenzhou
State/Province
Zhejiang
ZIP/Postal Code
325000
Country
China
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
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The Effect of Erythropoietin on Alveolar Fluid Clearance in Patients With Acute Respiratory Distress Syndrome

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