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.
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Förväntat)
Kontakter och platser
Studiekontakt
- Namn: Jonathan CHARBIT, MD
- Telefonnummer: 33 467338256
- E-post: j-charbit@chu-montpellier.fr
Studieorter
-
-
Montepllier
-
Montpellier, Montepllier, Frankrike, 34295
- Rekrytering
- Uhmontpellier
-
Kontakt:
- Jonathan CHARBIT, MD
- Telefonnummer: 33 467338256
- E-post: j-charbit@chu-montpellier.fr
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: Kohort
- Tidsperspektiv: Retrospektiv
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Occurrence of hyponatremia
Tidsram: during the 10 first days after the traumatic brain injury
|
Hyponatremia ≤ 135mmol/L
|
during the 10 first days after the traumatic brain injury
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Occurrence SIADH
Tidsram: 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
Tidsram: 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
Tidsram: 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
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Morbi-mortality
Tidsram: Day 1 (Hospitalization)
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Death, duration of mechanical ventilation, duration of renal replacement therapy, length of ICU stay and length of hospitalization.
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Day 1 (Hospitalization)
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Jonathan CHARBIT, MD, University Hospital, Montpellier
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- RECHMPL22_0011
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