Traumatic Brain Injury Clinical Trial
Official title:
Disturbances of the Sodium and Fluid Balance in Patients With Severe Traumatic Brain Injury and Non-traumatic Subarachnoid Hemorrhage. A Systematic Observational Study
During the course of their acute illness patients with subarachnoid hemorrhage and severe
traumatic brain injury often develop disturbances in their fluid balance and electrolyte
homeostasis. These shifts are associated with worse outcome and increased morbidity.
The aim of this observational study is to systematically analyze the incidence,
characteristics, potential diagnostic markers and predisposing factors of such disturbances.
The investigators hypothesize that many disturbances cannot be classified with a standard
diagnostic approach and that variable fluid management contributes to their pathophysiology.
Patients will be closely monitored clinically and the exact fluid and electrolyte balances
will be recorded. Treatment decisions are within the bedside physicians responsibility.
Baseline fluid management is standardised. No interventions are planned. The observation
period equal the duration of ICU stay.
Status | Completed |
Enrollment | 85 |
Est. completion date | January 2013 |
Est. primary completion date | January 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - non-traumatic subarachnoid hemorrhage - severe traumatic brain injury (GCS<9) Exclusion Criteria - younger than 18 years - time to admission after injury or bleed more than 7days - death expected in less than 12hours |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Switzerland | Dep. of Intensive Care Medicine Bern University Hospital | Bern |
Lead Sponsor | Collaborator |
---|---|
University Hospital Inselspital, Berne | Brahms AG, Foundation for research in Anaesthesie and Intensive Care Medicine |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of sodium-fluid disturbances | 14 days | No | |
Secondary | Type of sodium abnormality | 14 days | No | |
Secondary | Haemodynamic changes, 8hourly urine output, 8hourly fluid and sodium balance, changes in fluid management by treating doctors associated with sodium disturbances | We measure all parameters for multivariate analysis to find common predictors for sodium and fluid balance disturbances in these patients | 14 days | No |
Secondary | Associated changes in natriuretic peptide levels | 14 days | No |
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