- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT05301049
Prevalence, Severity, Risk Factors, and Prognostic Value of Hyponatremia in Patients With Traumatic Brain Injury (WATERWAR)
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.
Studieoversigt
Status
Betingelser
Detaljeret 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.
Undersøgelsestype
Tilmelding (Forventet)
Kontakter og lokationer
Studiekontakt
- Navn: Jonathan CHARBIT, MD
- Telefonnummer: 33 467338256
- E-mail: j-charbit@chu-montpellier.fr
Studiesteder
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-
Montepllier
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Montpellier, Montepllier, Frankrig, 34295
- Rekruttering
- UHMontpellier
-
Kontakt:
- Jonathan CHARBIT, MD
- Telefonnummer: 33 467338256
- E-mail: j-charbit@chu-montpellier.fr
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
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
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Kohorte
- Tidsperspektiver: Tilbagevirkende kraft
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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 |
Foranstaltningsbeskrivelse |
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)
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Jonathan CHARBIT, MD, University Hospital, Montpellier
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- RECHMPL22_0011
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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