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

NCT05301049 | Unknown

• 1 other identifier: RECHMPL22_0011
• Study Type: observational
• Target: 700
• Locations: 1 country
• Sites: 1

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.

Conditions

Traumatic Brain Injury

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Occurrence of hyponatremia

  Hyponatremia ≤ 135mmol/L

  during the 10 first days after the traumatic brain injury

Secondary Outcomes (4)

• Occurrence SIADH

  during the 10 first days after the traumatic brain injury

• Occurrence CSW

  during the 10 first days after the traumatic brain injury

• Determination of risk factors of hyponatremia

  during the 10 first days after the traumatic brain injury

• Morbi-mortality

  Day 1 (Hospitalization)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• âge ≥ 18 years
• presence of traumatic brain injury at the ICU admission

You may not qualify if:

• Discharged from ICU or death \< 48 hours from the admission
• Lack of data

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Uhmontpellier

Montpellier, Montepllier, 34295, France

RECRUITING

MeSH Terms

Conditions

Brain Injuries, Traumatic; Hyponatremia

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Jonathan CHARBIT, MD

  University Hospital, Montpellier

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jonathan CHARBIT, MD

CONTACT

467338256; j-charbit@chu-montpellier.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2022
• First Posted: March 29, 2022
• Study Start: February 1, 2022
• Primary Completion: June 28, 2022
• Study Completion: July 28, 2022
• Last Updated: March 29, 2022

Record last verified: 2022-03

Locations

FR (1)