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

NCT05857891 | Recruiting DMC

• 1 other identifier: SAHoWMU-CR2018-11-134
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Respiratory Distress Syndrome

Keywords

Erythropoietin; ARDS; Lung Water Clearance

Outcome Measures

Primary Outcomes (2)

• EVLWI

  extravascular lung water index

  Changes of EVLWI at 0,6,12,24 ,48 and 72 hours after intervention

• PVPI

  pulmonary vascular permeability index

  Changes of PVPI at 0,6,12,24 ,48 and 72 hours after intervention

Secondary Outcomes (2)

• Survival rate

  28-day hospital survival

• Oxygenation index

  Changes of oxygenation index at 0, 1, 2 and 3 days after intervention

Study Arms (2)

Erythropoietin group

EXPERIMENTAL

intravenous injection of 40000iu of rhEPO

Drug: Human erythropoietin injection

0.9%NS

PLACEBO COMPARATOR

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

Drug: 0.9%NaCl

Interventions

Human erythropoietin injection DRUG

Each subject in the test group received 40000iu of human erythropoietin intravenously

Also known as: Treatment measures taken according to the patient's condition

Erythropoietin group

0.9%NaCl DRUG

Each subject in the control group was injected with an equal volume of 0.9%NaCl

Also known as: Treatment measures taken according to the patient's condition

0.9%NS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Second Affiliated Hospital of Wenzhou Medical University: lead

Study Sites (1)

SAHWenzhouMU

Wenzhou, Zhejiang, 325000, China

RECRUITING

Related Publications (18)

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  PMID: 26903337 RESULT

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  PMID: 18179698 RESULT

• Gantner DC, Bailey M, Presneill J, French CJ, Nichol A, Little L, Bellomo R; EPO-TBI Investigators; the ANZICS Clinical Trials Group. Erythropoietin to Reduce Mortality in Traumatic Brain Injury: A Post-hoc Dose-effect Analysis. Ann Surg. 2018 Mar;267(3):585-589. doi: 10.1097/SLA.0000000000002142.

  PMID: 28151802 RESULT

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  PMID: 25888250 RESULT

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  PMID: 21269484 RESULT

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  PMID: 20501957 RESULT

• Voors AA, Belonje AM, Zijlstra F, Hillege HL, Anker SD, Slart RH, Tio RA, van 't Hof A, Jukema JW, Peels HO, Henriques JP, Ten Berg JM, Vos J, van Gilst WH, van Veldhuisen DJ; HEBE III Investigators. A single dose of erythropoietin in ST-elevation myocardial infarction. Eur Heart J. 2010 Nov;31(21):2593-600. doi: 10.1093/eurheartj/ehq304. Epub 2010 Aug 29.

  PMID: 20802250 RESULT

• Tsai TH, Lu CH, Wallace CG, Chang WN, Chen SF, Huang CR, Tsai NW, Lan MY, Sung PH, Liu CF, Yip HK. Erratum to: Erythropoietin improves long-term neurological outcome in acute ischemic stroke patients: a randomized, prospective, placebo-controlled clinical trial. Crit Care. 2016 Mar 31;20:78. doi: 10.1186/s13054-016-1256-y. No abstract available.

  PMID: 27037155 RESULT

• Suhs KW, Hein K, Sattler MB, Gorlitz A, Ciupka C, Scholz K, Kasmann-Kellner B, Papanagiotou P, Schaffler N, Restemeyer C, Bittersohl D, Hassenstein A, Seitz B, Reith W, Fassbender K, Hilgers R, Heesen C, Bahr M, Diem R. A randomized, double-blind, phase 2 study of erythropoietin in optic neuritis. Ann Neurol. 2012 Aug;72(2):199-210. doi: 10.1002/ana.23573.

  PMID: 22926853 RESULT

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  PMID: 17804841 RESULT

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  PMID: 21069520 RESULT

• Rocha J, Eduardo-Figueira M, Barateiro A, Fernandes A, Brites D, Pinto R, Freitas M, Fernandes E, Mota-Filipe H, Sepodes B. Erythropoietin reduces acute lung injury and multiple organ failure/dysfunction associated to a scald-burn inflammatory injury in the rat. Inflammation. 2015 Feb;38(1):312-26. doi: 10.1007/s10753-014-0035-7.

  PMID: 25270658 RESULT

• Tascilar O, Cakmak GK, Tekin IO, Emre AU, Ucan BH, Bahadir B, Acikgoz S, Irkorucu O, Karakaya K, Balbaloglu H, Kertis G, Ankarali H, Comert M. Protective effects of erythropoietin against acute lung injury in a rat model of acute necrotizing pancreatitis. World J Gastroenterol. 2007 Dec 14;13(46):6172-82. doi: 10.3748/wjg.v13.i46.6172.

  PMID: 18069756 RESULT

• MacRedmond R, Singhera GK, Dorscheid DR. Erythropoietin inhibits respiratory epithelial cell apoptosis in a model of acute lung injury. Eur Respir J. 2009 Jun;33(6):1403-14. doi: 10.1183/09031936.00084608. Epub 2009 Jan 22.

  PMID: 19164355 RESULT

• Heeschen C, Aicher A, Lehmann R, Fichtlscherer S, Vasa M, Urbich C, Mildner-Rihm C, Martin H, Zeiher AM, Dimmeler S. Erythropoietin is a potent physiologic stimulus for endothelial progenitor cell mobilization. Blood. 2003 Aug 15;102(4):1340-6. doi: 10.1182/blood-2003-01-0223. Epub 2003 Apr 17.

  PMID: 12702503 RESULT

• Shang Y, Li X, Prasad PV, Xu S, Yao S, Liu D, Yuan S, Feng D. Erythropoietin attenuates lung injury in lipopolysaccharide treated rats. J Surg Res. 2009 Jul;155(1):104-10. doi: 10.1016/j.jss.2008.10.003. Epub 2008 Nov 8.

  PMID: 19285686 RESULT

• Ware LB, Matthay MA. Alveolar fluid clearance is impaired in the majority of patients with acute lung injury and the acute respiratory distress syndrome. Am J Respir Crit Care Med. 2001 May;163(6):1376-83. doi: 10.1164/ajrccm.163.6.2004035.

  PMID: 11371404 RESULT

• Phillips CR, Chesnutt MS, Smith SM. Extravascular lung water in sepsis-associated acute respiratory distress syndrome: indexing with predicted body weight improves correlation with severity of illness and survival. Crit Care Med. 2008 Jan;36(1):69-73. doi: 10.1097/01.CCM.0000295314.01232.BE.

  PMID: 18090369 RESULT

MeSH Terms

Conditions

Respiratory Distress Syndrome

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Ye Gao, PhD

  Second Affiliated Hospital of Wenzhou Medical University

  STUDY DIRECTOR

Central Study Contacts

Shengwei Jin, Professor

CONTACT

13616663961; jinshengwei69@163.com

Yuqiang Gong, Professor

CONTACT

13858785608; gyq12120@163.com@163

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2023
• First Posted: May 15, 2023
• Study Start: May 20, 2023
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: May 15, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)