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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05301049
Acronym
WATERWAR
Enrollment
700
Registered
2022-03-29
Start date
2022-02-01
Completion date
2022-07-28
Last updated
2022-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Traumatic Brain Injury

Keywords

Hyponatremia, Syndrome of Inappropriate Anti Diuretic Hormone (SIADH), Cerebral Salt Waste Syndrome (CSW)

Brief summary

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.

Detailed description

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.

Interventions

None listed

Sponsors

University Hospital, Montpellier
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Occurrence of hyponatremiaduring the 10 first days after the traumatic brain injuryHyponatremia ≤ 135mmol/L

Secondary

MeasureTime frameDescription
Occurrence SIADHduring the 10 first days after the traumatic brain injuryHyponatremia ≤ 135mmol/L associated with inappropriate urine concentration (urinary/plasmatic osmolarity ≥1) and a low daily urine volume (\<1500 ml/24H).
Occurrence CSWduring the 10 first days after the traumatic brain injuryHyponatremia (≤135 mmol/L) associated with a massive natriuresis (\>140 mmol/L) and a daily urine volume \> 1500 ml/24H
Determination of risk factors of hyponatremiaduring the 10 first days after the traumatic brain injuryTraumatics injuries, early management, early complications, sodium and water intakes, treatments.
Morbi-mortalityDay 1 (Hospitalization)Death, duration of mechanical ventilation, duration of renal replacement therapy, length of ICU stay and length of hospitalization.

Countries

France

Contacts

Primary ContactJonathan CHARBIT, MD
j-charbit@chu-montpellier.fr467338256

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026