Hantavirus Nephropathy in North-Eastern France : Severity Risk Factors and Prognostic Tools (HANTA-NE)

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.

Study Overview

• Status: Completed
• Conditions: Hantavirus Nephropathy; Hantavirus Infection
• Intervention / Treatment: Other: HANTA-NE

• Study Type: Observational
• Enrollment (Actual): 101

Contacts and Locations

Study Locations

• France
  • Nancy, France, 54000
    • Central Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 125 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All adults patient hospitalized for hantavirus infection during study time frame.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• age under 18 years
• fulfill opposition form

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
HANTA-NE; All adult patient hospitalized for hantavirus infection between 01/01/2013 and 31/12/2022 in North Eastern France	Other: HANTA-NE; Observational cohort study

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Score performance to predict severity	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	Through study completion, an average of 2 years
Hypotension	Lowest systolic blood presure during hospitalisation < 90mmHg	Through study completion, an average of 2 years
Proteinuria	Proteinuria during hospitalisation defined by proteinuria/creatininuria above 500 mg/g or equivalent	Through study completion,an average of 2 years
Urinary dipstick	Leucocyturia or hematuria	Through study completion, an average of 2 years
ALAT, ASAT	Liver cytolysis	Through study completion, an average of 2 years
calcium	hypocalcemia, hypercalcemia	Through study completion, an average of 2 years
phosphorus	hypophaspahtaemia, hyperphasphatemia	Through study completion, an average of 2 years
potassium	hypokaliemia, hyperkaliemia	Through study completion, an average of 2 years
sodium	blood sodium level disorders	Through study completion, an average of 2 years
bicarbonate blood level	metabolic acidosis, metabolic alcalosis	Through study completion, an average of 2 years
Heamoglobin	Anemia	Through study completion, an average of 2 years
platelets level	thrombocytemia	Through study completion, an average of 2 years
Urine output	Polyruria above 3 L/day	Through study completion, an average of 2 years

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France
• Investigators: Principal Investigator: Alice CORBEL, M.D., Central Hospital, Nancy, France

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2022
• Primary Completion (Actual): October 30, 2023
• Study Completion (Actual): July 31, 2024

Study Registration Dates

• First Submitted: May 22, 2022
• First Submitted That Met QC Criteria: June 8, 2022
• First Posted (Actual): June 13, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 21, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Acute kidney injury; Hantavirus infection; Hantavirus nephropathy
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Respiration Disorders; Hemorrhagic Fevers, Viral; Respiratory Insufficiency; Bunyaviridae Infections; Kidney Diseases; Hantavirus Pulmonary Syndrome; Hantavirus Infections; Hemorrhagic Fever with Renal Syndrome
• Other Study ID Numbers: 2022PI034

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No