Trials / Completed
CompletedNCT01313975
Electrolyte and Fluid Disturbances in Subarachnoid Hemorrhage and Traumatic Brain Injury
Disturbances of the Sodium and Fluid Balance in Patients With Severe Traumatic Brain Injury and Non-traumatic Subarachnoid Hemorrhage. A Systematic Observational Study
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 85 (actual)
- Sponsor
- Insel Gruppe AG, University Hospital Bern · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
Background Electrolyte disturbances and fluid shifts are common in patients with subarachnoid hemorrhage (SAH) or traumatic brain injury (TBI). They usually have a rapid onset with impact on morbidity (possibly mortality) and length of stay. So far the understanding of underlying pathophysiologies and the contribution of iatrogenic influences is not fully understood. Only limited evidence and data on classification, management and outcome of patients exists. Objective To describe the incidence, characteristics and duration of sodium and fluid disturbances in patients with SAH or TBI. To document exact fluid and electrolyte management To evaluate predisposing factors and potential predicting biomarkers such as natriuretic peptides, renin-aldosterone system. Methods Prospective systematic observational study with 50 patients in the SAH group and 50 patients in the TBI group. 8hourly clinical assessment, blood and urin samples. Defined trigger points for additional measurements. Continuous fluid balance documentation Daily measurement of natriuretic peptides, aldosterone and renin
Conditions
Timeline
- Start date
- 2011-01-01
- Primary completion
- 2013-01-01
- Completion
- 2013-01-01
- First posted
- 2011-03-14
- Last updated
- 2013-04-17
Locations
1 site across 1 country: Switzerland
Source: ClinicalTrials.gov record NCT01313975. Inclusion in this directory is not an endorsement.