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Completed

NCT Number: NCT05415904

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

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.

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Key information

Conditions

Hantavirus Nephropathy Acute Kidney Injury Bunyaviridae Infections Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hantavirus Infection Hantavirus Infections Infections Kidney Diseases Male Urogenital Diseases RNA Virus Infections Renal Insufficiency Urogenital Diseases Urologic Diseases Virus Diseases

Age range

18 year–125 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Central Hospital

Nancy, 54000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • age under 18 years
  • fulfill opposition form

Treatment and study plan

HANTA-NE

Other

Observational cohort study

Primary outcomes

  1. Creatinin level

    Time frame: Through study completion, an average of 2 years

    Acute Kidney injury KDIGO 3

  2. Hemorrhagic syndrome

    Time frame: Through study completion, an average of 2 years

    Major bleeding requiring blood transfusion

  3. Death

    Time frame: Through study completion, an average of 2 years

    Death

  4. Hospitalisation in intensive care unit

    Time frame: Through study completion, an average of 2 years

    Hospitalisation in intensive care unit

Secondary outcomes

  1. Score performance to predict severity

    Time frame: 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

  2. Hypotension

    Time frame: Through study completion, an average of 2 years

    Lowest systolic blood presure during hospitalisation < 90mmHg

  3. Proteinuria

    Time frame: Through study completion,an average of 2 years

    Proteinuria during hospitalisation defined by proteinuria/creatininuria above 500 mg/g or equivalent

  4. Urinary dipstick

    Time frame: Through study completion, an average of 2 years

    Leucocyturia or hematuria

  5. ALAT, ASAT

    Time frame: Through study completion, an average of 2 years

    Liver cytolysis

  6. calcium

    Time frame: Through study completion, an average of 2 years

    hypocalcemia, hypercalcemia

  7. phosphorus

    Time frame: Through study completion, an average of 2 years

    hypophaspahtaemia, hyperphasphatemia

  8. potassium

    Time frame: Through study completion, an average of 2 years

    hypokaliemia, hyperkaliemia

  9. sodium

    Time frame: Through study completion, an average of 2 years

    blood sodium level disorders

  10. bicarbonate blood level

    Time frame: Through study completion, an average of 2 years

    metabolic acidosis, metabolic alcalosis

  11. Heamoglobin

    Time frame: Through study completion, an average of 2 years

    Anemia

  12. platelets level

    Time frame: Through study completion, an average of 2 years

    thrombocytemia

  13. Urine output

    Time frame: Through study completion, an average of 2 years

    Polyruria above 3 L/day

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Acronym: HANTA-NE

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Jun 13, 2022
Registry last updated
Feb 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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