Status:
UNKNOWN
Efficacy of Intravenous Immunoglobulin in Patients With Hemorrhagic Fever With Renal Syndrome: a Prospective Study
Lead Sponsor:
Tongji Hospital
Conditions:
HFRS (Hemorrhagic Fever With Renal Syndrome)
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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 c...
Detailed Description
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 H...
Eligibility Criteria
Inclusion
- The patients must meet all of the following criteria:
- Age ≥ 18 years, regardless of gender;
- Within 5 days of onset, hospitalized patients diagnosed with epidemic hemorrhagic fever (hemorrhagic fever with renal syndrome) must have at least one of the following laboratory test results:
- Positive for serum specific IgM(immunoglobulin M) antibodies;
- Or detect hantavirus RNA(ribonucleic acid) from patient specimens;
- Or the serum specific IgG(immunoglobulin G) antibody titer in the recovery phase is more than four times higher than that in the acute phase;
- Or hantavirus can be isolated from patient specimens.
- Meet any of the following criteria:
- 1\. Severe illness: meet any of the following criteria: (i) Platelet count 20-50×10\^9/L; (ii) White blood cell count 15-30×10\^9/L. 2. Critical illness: meet any of the following criteria: (i) Platelet count\<20×10\^9/L; (ii) White blood cell count\>30×10\^9/L.
- Volunteer to join this study and be able to sign or have a written informed consent form signed by a legal representative.
Exclusion
- Exclude patients who meet any of the following criteria:
- Patients with primary chronic kidney disease;
- Patients with severe diabetes, hypertension, heart, lung, gastrointestinal tract, liver, autoimmune disease or nervous system disease;
- Have a history of malignant tumors (including solid malignant tumors and hematological malignancies etc.);
- Recent use of potentially nephrotoxic drugs;
- Pregnant or potentially pregnant patients;
- Patients with a history of hypersensitivity to IVIG (intravenous immunoglobulin) ;
- Selective IgA(immunoglobulin A) deficiency patients with IgA antibodies;
- Known or suspected immunodeficiency (human immunodeficiency virus infection, primary immunodeficiency), use of immunosuppressive drugs (glucocorticoids);
- Alcoholics, drug abuse, and psychiatric patients
- Other conditions which researchers deem not suitable for inclusion.
Key Trial Info
Start Date :
July 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2024
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06009042
Start Date
July 1 2022
End Date
June 30 2024
Last Update
August 24 2023
Active Locations (9)
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1
No.1 Peoples Hospital of Guangshui
Guangshui, Hubei, China
2
Huanggang Central Hospital
Huanggang, Hubei, China
3
People's Hospital of Luotian County
Huanggang, Hubei, China
4
People's Hospital of Macheng City, Affiliated Hospital of Hubei University of Science and Technology
Macheng, Hubei, China