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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
The dose of IVIG(intravenous immunoglobulin) is 20g/d. Participants also receive conventional liquid therapy and symptomatic and supportive treatment.
The dose of IVIG(intravenous immunoglobulin) is 10g/d. Participants also receive conventional liquid therapy and symptomatic and supportive treatment.
No.1 Peoples Hospital of Guangshui
Guangshui, Hubei, China
RECRUITINGHuanggang Central Hospital
Huanggang, Hubei, China
RECRUITINGPeople's Hospital of Luotian County
Huanggang, Hubei, China
RECRUITINGPeople's Hospital of Macheng City, Affiliated Hospital of Hubei University of Science and Technology
Macheng, Hubei, China
RECRUITINGQianjiang Central Hospital
Qianjiang, Hubei, China
RECRUITINGTongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology
Wuhan, Hubei, China
RECRUITINGXianning Central Hospital
Xianning, Hubei, China
RECRUITINGThe Third Peoples Hospital of Yichang
Yichang, Hubei, China
RECRUITINGJiangsu Province Hospital
Nanjing, Jiangsu, China
RECRUITINGTransformation rate
The transformation rate is defined as the rate of transformation \[critical to severe, moderate or mild, severe to moderate or mild\], or the rate of transition \[severe to critical\].
Time frame: up to 34th day after treatment
Post-period rate
Post-period rate is defined as post-hypotension shock phase or oliguric phase, or post-hypotension shock phase and oliguric phase
Time frame: up to 34th day after treatment
Mortality rate
Time frame: up to 34th day after treatment
The duration of the disease
The duration of the disease is defined as the duration from symptom onset to recovery and discharge.
Time frame: up to 34th day after treatment
The incidence of complications
The incidence of complications is defined as the incidence of shock, renal failure, disseminated intravascular coagulation.
Time frame: up to 34th day after treatment
length of hospital stay
The length of hospital stay is defined as the number of days from admission to discharge.
Time frame: up to 34th day after treatment
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