Clinical trial
The Effect of Erythropoietin on Alveolar Fluid Clearance in Patients With Acute Respiratory Distress Syndrome
Name
SAHoWMU-CR2018-11-134
Description
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.
Trial arms
Trial start
2023-05-20
Estimated PCD
2026-10-31
Trial end
2027-03-31
Status
Recruiting
Treatment
Human erythropoietin injection
Each subject in the test group received 40000iu of human erythropoietin intravenously
Arms:
Erythropoietin group
Other names:
Treatment measures taken according to the patient's condition
0.9%NaCl
Each subject in the control group was injected with an equal volume of 0.9%NaCl
Arms:
0.9%NS
Other names:
Treatment measures taken according to the patient's condition
Size
40
Primary endpoint
EVLWI
Changes of EVLWI at 0,6,12,24 ,48 and 72 hours after intervention
PVPI
Changes of PVPI at 0,6,12,24 ,48 and 72 hours after intervention
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;
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 40, 'type': 'ESTIMATED'}}
Updated at
2023-05-15
1 organization