Hantavirus Nephropathy in North-Eastern France : Severity Risk Factors and Prognostic Tools

Completed

• Conditions: Hantavirus Nephropathy; Hantavirus Infection
• Interventions: Other: HANTA-NE

• Registration Number: NCT05415904
• Lead Sponsor: Central Hospital, Nancy, France

Brief Summary

Hantaviruses are emerging pathogens responsible for hemorrhagic fever with renal syndrome. Severity risks factors aren't consensual in litterature, mostly related to scandinavian cohorts. A prognostic score was created to help patient's orientation in healthcare system but wasn't independantly validated (Hentzien, Emerging infectious diseases 2018).

This retrospective cohort of hantavirus infected hospitalized adults patients in the north-eastern quarter of France between 2013 and 2022 will specify the kidney damage during infection and risk factors for a severe form (defined par acute kidney injury KDIGO 3). The previous prognostic score performance will be evaluated in this cohort.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-05-20
• Study First Submitted: 2022-05-22
• Study First Submitted QC: 2022-06-08
• Study First Posted: 2022-06-13
• Primary Completion: 2023-10-30
• Study Completion: 2024-07-31
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-21
• Last Update Posted: 2025-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

Inclusion Criteria

• hantavirus proven by serology infection
• age above 18 years
• Hospitalisation

Exclusion Criteria

• age under 18 years
• fulfill opposition form

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
HANTA-NE	HANTA-NE	All adult patient hospitalized for hantavirus infection between 01/01/2013 and 31/12/2022 in North Eastern France

Primary Outcome Measures

Name	Time	Method
Creatinin level	Through study completion, an average of 2 years	Acute Kidney injury KDIGO 3
Hospitalisation in intensive care unit	Through study completion, an average of 2 years	Hospitalisation in intensive care unit
Hemorrhagic syndrome	Through study completion, an average of 2 years	Major bleeding requiring blood transfusion
Death	Through study completion, an average of 2 years	Death

Secondary Outcome Measures

Name	Time	Method
Score performance to predict severity	Through study completion, an average of 2 years	Correlation between severity predicted by the score and bio-clinical severity during hospitalization.; Score composition : Hematuria = 7 Visual disorders = 8 Leucocyte count \> 10 x 10\^9 cells/L = 9 Nephrotoxic drug exposure (NSAID, iodinated contrast media, diuretics, renin angiotensin aldosterone system inhibitors, aminoglycosides, glycopeptides) = 10 Thrombocytopenia \< or = 90 000/mm3 = 11; Risk group according score scale 0-10 Low risk 11-19 intermediate risk 20-45 high risk
Proteinuria	Through study completion,an average of 2 years	Proteinuria during hospitalisation defined by proteinuria/creatininuria above 500 mg/g or equivalent
calcium	Through study completion, an average of 2 years	hypocalcemia, hypercalcemia
Urinary dipstick	Through study completion, an average of 2 years	Leucocyturia or hematuria
phosphorus	Through study completion, an average of 2 years	hypophaspahtaemia, hyperphasphatemia
sodium	Through study completion, an average of 2 years	blood sodium level disorders
Heamoglobin	Through study completion, an average of 2 years	Anemia
ALAT, ASAT	Through study completion, an average of 2 years	Liver cytolysis
bicarbonate blood level	Through study completion, an average of 2 years	metabolic acidosis, metabolic alcalosis
potassium	Through study completion, an average of 2 years	hypokaliemia, hyperkaliemia
Urine output	Through study completion, an average of 2 years	Polyruria above 3 L/day
Hypotension	Through study completion, an average of 2 years	Lowest systolic blood presure during hospitalisation \< 90mmHg
platelets level	Through study completion, an average of 2 years	thrombocytemia

Trial Locations

Locations (1)

Central Hospital; 🇫🇷 Nancy, France