An observational study in Traumatic Brain Injury, sponsored by University Hospital, Montpellier. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-03-29.
Sponsored by University Hospital, Montpellier · Observational
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.
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.
2,114 studies on the registry are indexed under Brain Injuries; 386 are open to participants now.
This study's planned enrollment of 700 is above the median of 100 across 690 observational studies indexed under Brain Injuries.
Browse Brain Injuries studies →University Hospital, Montpellier is the lead sponsor of 1,244 studies on the registry; 224 are open to participants now.
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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.
Exclusion criteria:
Occurrence of hyponatremia
Hyponatremia ≤ 135mmol/L
Time frame: during the 10 first days after the traumatic brain injury
Occurrence SIADH
Hyponatremia ≤ 135mmol/L associated with inappropriate urine concentration (urinary/plasmatic osmolarity ≥1) and a low daily urine volume (\<1500 ml/24H).
Time frame: during the 10 first days after the traumatic brain injury
Occurrence CSW
Hyponatremia (≤135 mmol/L) associated with a massive natriuresis (\>140 mmol/L) and a daily urine volume \> 1500 ml/24H
Time frame: during the 10 first days after the traumatic brain injury
Determination of risk factors of hyponatremia
Traumatics injuries, early management, early complications, sodium and water intakes, treatments.
Time frame: during the 10 first days after the traumatic brain injury
Morbi-mortality
Death, duration of mechanical ventilation, duration of renal replacement therapy, length of ICU stay and length of hospitalization.
Time frame: Day 1 (Hospitalization)
Plan to share: Undecided — NC
No publications or documents are linked to this record.
This study is status unknown, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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University Hospital, Montpellier