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

Sponsor
Central Hospital, Nancy, France (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05415904
Collaborator
(none)
170
1
26.4
6.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: HANTA-NE

Study Design

Study Type:
Observational
Anticipated Enrollment :
170 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Hantavirus Nephropathy in North-Eastern France : Severity Risk Factors and Prognostic Tools
Actual Study Start Date :
May 20, 2022
Anticipated Primary Completion Date :
Oct 30, 2023
Anticipated Study Completion Date :
Jul 31, 2024

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Creatinin level [Through study completion, an average of 2 years]

    Acute Kidney injury KDIGO 3

  2. Hemorrhagic syndrome [Through study completion, an average of 2 years]

    Major bleeding requiring blood transfusion

  3. Death [Through study completion, an average of 2 years]

    Death

  4. Hospitalisation in intensive care unit [Through study completion, an average of 2 years]

    Hospitalisation in intensive care unit

Secondary Outcome Measures

  1. 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

  2. Hypotension [Through study completion, an average of 2 years]

    Lowest systolic blood presure during hospitalisation < 90mmHg

  3. Proteinuria [Through study completion,an average of 2 years]

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

  4. Urinary dipstick [Through study completion, an average of 2 years]

    Leucocyturia or hematuria

  5. ALAT, ASAT [Through study completion, an average of 2 years]

    Liver cytolysis

  6. calcium [Through study completion, an average of 2 years]

    hypocalcemia, hypercalcemia

  7. phosphorus [Through study completion, an average of 2 years]

    hypophaspahtaemia, hyperphasphatemia

  8. potassium [Through study completion, an average of 2 years]

    hypokaliemia, hyperkaliemia

  9. sodium [Through study completion, an average of 2 years]

    blood sodium level disorders

  10. bicarbonate blood level [Through study completion, an average of 2 years]

    metabolic acidosis, metabolic alcalosis

  11. Heamoglobin [Through study completion, an average of 2 years]

    Anemia

  12. platelets level [Through study completion, an average of 2 years]

    thrombocytemia

  13. Urine output [Through study completion, an average of 2 years]

    Polyruria above 3 L/day

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 125 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • hantavirus proven by serology infection

  • age above 18 years

  • Hospitalisation

Exclusion Criteria:
  • age under 18 years

  • fulfill opposition form

Contacts and Locations

Locations

Site City State Country Postal Code
1 Central Hospital Nancy France 54000

Sponsors and Collaborators

  • Central Hospital, Nancy, France

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
CORBEL Alice, Principal investigator, Central Hospital, Nancy, France
ClinicalTrials.gov Identifier:
NCT05415904
Other Study ID Numbers:
  • 2022PI034
First Posted:
Jun 13, 2022
Last Update Posted:
Jun 13, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by CORBEL Alice, Principal investigator, Central Hospital, Nancy, France
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 13, 2022