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

May 4, 2023 updated by: Second Affiliated Hospital of Wenzhou Medical University
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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:

  1. The subjects of this study were patients with ARDS admitted to ICU.
  2. 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.
  3. 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.
  4. 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.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Zhejiang
      • Wenzhou, Zhejiang, China, 325000
        • Recruiting
        • SAHWenzhouMU

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Erythropoietin group
intravenous injection of 40000iu of rhEPO
Drug: Human erythropoietin injection
Each subject in the test group received 40000iu of human erythropoietin intravenously
Other Names:
  • Treatment measures taken according to the patient's condition
Placebo Comparator: 0.9%NS
intravenous injection of the same volume of 0.9%NS as the test group
Drug: 0.9%NaCl
Each subject in the control group was injected with an equal volume of 0.9%NaCl
Other Names:
  • Treatment measures taken according to the patient's condition

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
EVLWI
Time Frame: Changes of EVLWI at 0,6,12,24 ,48 and 72 hours after intervention
extravascular lung water index
Changes of EVLWI at 0,6,12,24 ,48 and 72 hours after intervention
PVPI
Time Frame: Changes of PVPI at 0,6,12,24 ,48 and 72 hours after intervention
pulmonary vascular permeability index
Changes of PVPI at 0,6,12,24 ,48 and 72 hours after intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival rate
Time Frame: 28-day hospital survival
28-day survival rate
28-day hospital survival
Oxygenation index
Time Frame: Changes of oxygenation index at 0, 1, 2 and 3 days after intervention
PaO2/FiO2
Changes of oxygenation index at 0, 1, 2 and 3 days after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital of Wenzhou Medical University

Investigators

  • Study Director: Ye Gao, PhD, Second Affiliated Hospital of Wenzhou Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 20, 2023

Primary Completion (Anticipated)

October 31, 2026

Study Completion (Anticipated)

March 31, 2027

Study Registration Dates

First Submitted

April 24, 2023

First Submitted That Met QC Criteria

May 4, 2023

First Posted (Actual)

May 15, 2023

Study Record Updates

Last Update Posted (Actual)

May 15, 2023

Last Update Submitted That Met QC Criteria

May 4, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SAHoWMU-CR2018-11-134

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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