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| Name | Class |
|---|---|
| Foundation for research in Anaesthesie and Intensive Care Medicine | UNKNOWN |
| Brahms AG | INDUSTRY |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Patients with non-traumatic subarachnoid hemorrhage | ||
| 2 | Patients with severe traumatic brain injury |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of sodium-fluid disturbances | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Type of sodium abnormality | 14 days | |
| 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 |
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Inclusion Criteria:
Exclusion Criteria
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Intenisve Care Medicine patients with non-traumatic subarachnoid hemorrhage or severe traumatic brain injury
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| Name | Affiliation | Role |
|---|---|---|
| Jan Wiegand, MD | Dep. Intensive Care Medicine, University Hospitals Bern | Principal Investigator |
| Stephan Jakob, MD, PhD | Dep. Intensive Care Medicine, University Hospitals Bern | Study Director |
| Jukka Takala, MD PhD | Dep. Intensive Care Medicine, University Hospitals Bern | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dep. of Intensive Care Medicine Bern University Hospital | Bern | 3010 | Switzerland |
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| ID | Term |
|---|---|
| D013345 | Subarachnoid Hemorrhage |
| D000070642 | Brain Injuries, Traumatic |
| D007177 | Inappropriate ADH Syndrome |
| D003919 | Diabetes Insipidus |
| ID | Term |
|---|---|
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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serum and urine samples
| 14 days |
| Associated changes in natriuretic peptide levels | 14 days |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001930 | Brain Injuries |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D010900 | Pituitary Diseases |
| D007027 | Hypothalamic Diseases |
| D014883 | Water-Electrolyte Imbalance |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |