Electrolyte and Fluid Disturbances in Subarachnoid Hemorrhage and Traumatic Brain Injury
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|ClinicalTrials.gov Identifier: NCT01313975|
Recruitment Status : Completed
First Posted : March 14, 2011
Last Update Posted : April 17, 2013
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 or disease|
|Electrolyte Disturbances Subarachnoid Hemorrhage Traumatic Brain Injury Natriuretic Peptides|
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.
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.
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
|Study Type :||Observational|
|Actual Enrollment :||85 participants|
|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|
|Study Start Date :||January 2011|
|Actual Primary Completion Date :||January 2013|
|Actual Study Completion Date :||January 2013|
Patients with non-traumatic subarachnoid hemorrhage
Patients with severe traumatic brain injury
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01313975
|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|