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Electrolyte and Fluid Disturbances in Subarachnoid Hemorrhage and Traumatic Brain Injury
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Purpose
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.
| Condition |
|---|
| Electrolyte Disturbances Subarachnoid Hemorrhage Traumatic Brain Injury Natriuretic Peptides |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| 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 |
- Incidence of sodium-fluid disturbances [ Time Frame: 14 days ]
- Type of sodium abnormality [ Time Frame: 14 days ]
- Haemodynamic changes, 8hourly urine output, 8hourly fluid and sodium balance, changes in fluid management by treating doctors associated with sodium disturbances [ Time Frame: 14 days ]We measure all parameters for multivariate analysis to find common predictors for sodium and fluid balance disturbances in these patients
- Associated changes in natriuretic peptide levels [ Time Frame: 14 days ]
Biospecimen Retention: Samples With DNA
| Enrollment: | 85 |
| Study Start Date: | January 2011 |
| Study Completion Date: | January 2013 |
| Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
1
Patients with non-traumatic subarachnoid hemorrhage
|
|
2
Patients with severe traumatic brain injury
|
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
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
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
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01313975
| Switzerland | |
| Dep. of Intensive Care Medicine Bern University Hospital | |
| Bern, Switzerland, 3010 | |
| Principal Investigator: | Jan Wiegand, MD | Dep. Intensive Care Medicine, University Hospitals Bern |
| Study Director: | Stephan Jakob, MD, PhD | Dep. Intensive Care Medicine, University Hospitals Bern |
| Study Chair: | Jukka Takala, MD PhD | Dep. Intensive Care Medicine, University Hospitals Bern |
More Information
| Responsible Party: | Jan Wiegand, MD, Department of Intensive Care Medicine University Hospital Bern, Switzerland |
| ClinicalTrials.gov Identifier: | NCT01313975 History of Changes |
| Other Study ID Numbers: |
203/10 |
| Study First Received: | February 21, 2011 |
| Last Updated: | April 16, 2013 |
Keywords provided by University Hospital Inselspital, Berne:
|
Electrolyte disturbances Fluid balance subarachnoid hemorrhage traumatic brain injury |
Cerebral salt wasting SIADH Diabetes insipidus |
Additional relevant MeSH terms:
|
Wounds and Injuries Brain Injuries Hemorrhage Subarachnoid Hemorrhage Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Craniocerebral Trauma Trauma, Nervous System Pathologic Processes Intracranial Hemorrhages Cerebrovascular Disorders Vascular Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on June 23, 2017