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Efficacy of Intravenous Immunoglobulin in Patients With Hemorrhagic Fever With Renal Syndrome: a Multicenter, Prospective, Randomized Controlled Study
The goal of this randomized study to test the efficacy of different doses of IVIG (intravenous immunoglobulin) in the treatment of severe HFRS(hemorrhagic fever with renal syndrome), and provide new clinical ideas for the treatment and prognosis of HFRS patients in the future. This study will include all hospitalized patients with confirmed severe or critically ill HFRS from October 2021 to October 2023 from 9 centers. Participants will receive IVIG 10g/d or IVIG 20g/d. All the participants will be given conventional liquid therapy and symptomatic and supportive treatment. Participants will be collected demographic, epidemiological history, hospitalization information, clinical data, laboratory data, imaging results, treatment regimens, and outcomes data.
This is a multicenter, prospective, randomized controlled study which aims at evaluating the efficacy of different doses of IVIG (intravenous immunoglobulin) in the treatment of patients with severe HFRS(hemorrhagic fever with renal syndrome), and providing reference for the future application of IVIG in severe hemorrhagic fever with renal syndrome. This study will include approximately 100 patients with severe hemorrhagic fever with renal syndrome who are randomly assigned to either the IVIG 10g/d group or the IVIG 20g/d group in a 1:1 ratio. The participants in each group will receive treatments for 6 days. Both groups are given routine liquid therapy and symptomatic supportive treatment. The main endpoints include transformation rate, post-period rate, mortality rate, and duration of the disease. Secondary endpoints include the incidence of complications and length of hospital stay.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
No.1 Peoples Hospital of Guangshui
Guangshui, Hubei, China
Huanggang Central Hospital
Huanggang, Hubei, China
People's Hospital of Luotian County
Huanggang, Hubei, China
People's Hospital of Macheng City, Affiliated Hospital of Hubei University of Science and Technology
Macheng, Hubei, China
Qianjiang Central Hospital
Qianjiang, Hubei, China
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology
Wuhan, Hubei, China
Xianning Central Hospital
Xianning, Hubei, China
The Third Peoples Hospital of Yichang
Yichang, Hubei, China
Jiangsu Province Hospital
Nanjing, Jiangsu, China
Start Date
July 1, 2022
Primary Completion Date
June 30, 2024
Completion Date
June 30, 2024
Last Updated
August 24, 2023
100
ESTIMATED participants
IVIG 20g/d
DRUG
IVIG 10g/d
DRUG
Lead Sponsor
Tongji Hospital
Data Source & Attribution
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