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

• Conditions: Traumatic Brain Injury

• Registration Number: NCT05301049
• Lead Sponsor: University Hospital, Montpellier

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.

Study Timeline

• Study Start: 2022-02-01
• Study First Submitted: 2022-02-07
• Status Verified: 2022-03
• Study First Submitted QC: 2022-03-28
• Last Update Submitted: 2022-03-28
• Study First Posted: 2022-03-29
• Last Update Posted: 2022-03-29
• Primary Completion: 2022-06-28
• Study Completion: 2022-07-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 700

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Occurrence of hyponatremia	during the 10 first days after the traumatic brain injury	Hyponatremia ≤ 135mmol/L

Secondary Outcome Measures

Name	Time	Method
Occurrence SIADH	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).
Occurrence CSW	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
Determination of risk factors of hyponatremia	during the 10 first days after the traumatic brain injury	Traumatics injuries, early management, early complications, sodium and water intakes, treatments.
Morbi-mortality	Day 1 (Hospitalization)	Death, duration of mechanical ventilation, duration of renal replacement therapy, length of ICU stay and length of hospitalization.

Trial Locations

Locations (1)

Uhmontpellier; 🇫🇷 Montpellier, Montepllier, France