Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

Prevalence, Severity, Risk Factors, and Prognostic Value of Hyponatremia in Patients With Traumatic Brain Injury (WATERWAR)

28. mars 2022 oppdatert av: University Hospital, Montpellier

Prevalence, Severity, Risk Factors, and Prognostic Value of Hyponatremia in Patients With Traumatic Brain Injury : a Retrospective Cohort Study.

Hyponatremia (HN) is the most common electrolytic disorder in the traumatic brain injury (TBI) population, found in 17 to 51% of patients according to the series. Two etiologies predominate in the literature, the Syndrome of Inappropriate Anti Diuretic Hormone (SIADH) and the Cerebral Salt Waste Syndrome (CSW), but none has been precisely described in terms of epidemiology, risk factors or severity. Moreover, SIADH and CSH were often confused in previous works.

The main goal of our study is to assess retrospectively prevalence, severity, time to onset, length, risk factors of HN in a large population of TBI patients, as well as treatment modalities and prognosis. A specific distinction was performed between SIADH or CSW.

Studieoversikt

Status

Rekruttering

Forhold

Traumatisk hjerneskade

Detaljert beskrivelse

This is a retrospective descriptive study.

The included patients will be those admitted in the trauma intensive care unit of Lapeyronie University Hospital (Montpellier, France) with a TBI (head AIS ≥1) during a period of 4 years, 01/01/2014 to 31/12/2017.

Using our databank the investigators estimate 650 to 700 patients who met inclusion criteria during this period and will be analyzed. Inclusions will be confirmed after the opening of medical records.

Definition of SIADH is defined as the occurrence of a hyponatremia (≤135 mmol/L) associated with inappropriate urine concentration (urinary/plasmatic osmolarity ≥1) and a low daily urine volume (<1500 ml/24H).

Definition of CSW is defined as the occurrence of a hyponatremia (≤135 mmol/L) associated with a massive natriuresis (>140 mmol/L) and a daily urine volume > 1500 ml/24H.

Data collection will concern the medical records: medical history, traumatism severity, cerebral injuries on computed tomography, severe complications, specific treatments, and biological course from ICU admission to discharge.

The main endpoint will be the prevalence of hyponatremia (≤135 mmol/L) in the first 10 days after the traumatic brain injury.

The secondary endpoints will be the prevalence specific prevalence of CSW and SIADH, risk factors of these nosological entities, their severity, their timing to onset and their morbimorality.

Studietype

Observasjonsmessig

Registrering (Forventet)

700

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Navn: Jonathan CHARBIT, MD
Telefonnummer: 33 467338256
E-post: j-charbit@chu-montpellier.fr

Studiesteder

Frankrike
- Montepllier
  - Montpellier, Montepllier, Frankrike, 34295
    - Rekruttering
    - Uhmontpellier
    - Ta kontakt med:
      
      Jonathan CHARBIT, MD
      
      Telefonnummer: 33 467338256
      
      E-post: j-charbit@chu-montpellier.fr

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

Patients admitted in the trauma intensive care unit of the Lapeyronie university hospital (Montpellier, France) with a traumatic brain injury Period of 4 years between 01/01/2014 and 31/12/2017.

Beskrivelse

Inclusion criteria:

âge ≥ 18 years
presence of traumatic brain injury at the ICU admission

Exclusion criteria:

Discharged from ICU or death < 48 hours from the admission
Lack of data

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Observasjonsmodeller: Kohort
Tidsperspektiver: Retrospektiv

Hva måler studien?

Primære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
Occurrence of hyponatremia Tidsramme: during the 10 first days after the traumatic brain injury	Hyponatremia ≤ 135mmol/L	during the 10 first days after the traumatic brain injury

Sekundære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
Occurrence SIADH Tidsramme: during the 10 first days after the traumatic brain injury	Hyponatremia ≤ 135mmol/L associated with inappropriate urine concentration (urinary/plasmatic osmolarity ≥1) and a low daily urine volume (<1500 ml/24H).	during the 10 first days after the traumatic brain injury
Occurrence CSW Tidsramme: during the 10 first days after the traumatic brain injury	Hyponatremia (≤135 mmol/L) associated with a massive natriuresis (>140 mmol/L) and a daily urine volume > 1500 ml/24H	during the 10 first days after the traumatic brain injury
Determination of risk factors of hyponatremia Tidsramme: during the 10 first days after the traumatic brain injury	Traumatics injuries, early management, early complications, sodium and water intakes, treatments.	during the 10 first days after the traumatic brain injury
Morbi-mortality Tidsramme: Day 1 (Hospitalization)	Death, duration of mechanical ventilation, duration of renal replacement therapy, length of ICU stay and length of hospitalization.	Day 1 (Hospitalization)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University Hospital, Montpellier

Etterforskere

Hovedetterforsker: Jonathan CHARBIT, MD, University Hospital, Montpellier

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. februar 2022

Primær fullføring (Forventet)

28. juni 2022

Studiet fullført (Forventet)

28. juli 2022

Datoer for studieregistrering

Først innsendt

7. februar 2022

Først innsendt som oppfylte QC-kriteriene

28. mars 2022

Først lagt ut (Faktiske)

29. mars 2022

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)