Clinical trial NCT05415904: Hantavirus Nephropathy in North-Eastern France : Severity Risk Factors and Prognostic Tools
Official title: Hantavirus Nephropathy in North-Eastern France : Severity Risk Factors and Prognostic Tools
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hantavirus Nephropathy
Hantavirus Infection
Keywords: Acute kidney injury
Hantavirus infection
Hantavirus nephropathy
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2022-06-13
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Maximum age (years): 125
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All adults patient hospitalized for hantavirus infection during study time frame.

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* age under 18 years
* fulfill opposition form

Primary outcomes:
measure: Creatinin level
timeFrame: Through study completion, an average of 2 years
measure: Hemorrhagic syndrome
timeFrame: Through study completion, an average of 2 years
measure: Death
timeFrame: Through study completion, an average of 2 years
measure: Hospitalisation in intensive care unit
timeFrame: Through study completion, an average of 2 years
Secondary outcomes:
measure: Score performance to predict severity
timeFrame: Through study completion, an average of 2 years
measure: Hypotension
timeFrame: Through study completion, an average of 2 years
measure: Proteinuria
timeFrame: Through study completion,an average of 2 years
measure: Urinary dipstick
timeFrame: Through study completion, an average of 2 years
measure: ALAT, ASAT
timeFrame: Through study completion, an average of 2 years
measure: calcium
timeFrame: Through study completion, an average of 2 years
measure: phosphorus
timeFrame: Through study completion, an average of 2 years
measure: potassium
timeFrame: Through study completion, an average of 2 years
measure: sodium
timeFrame: Through study completion, an average of 2 years
measure: bicarbonate blood level
timeFrame: Through study completion, an average of 2 years
measure: Heamoglobin
timeFrame: Through study completion, an average of 2 years
measure: platelets level
timeFrame: Through study completion, an average of 2 years
measure: Urine output
timeFrame: Through study completion, an average of 2 years
Other outcomes:
Locations:
city: Nancy
country: France
facility: Central Hospital
Study officials:
affiliation: Central Hospital, Nancy, France
name: Alice CORBEL, M.D.
role: PRINCIPAL_INVESTIGATOR
References: