Electrolyte and Fluid Disturbances in Subarachnoid Hemorrhage and Traumatic Brain Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01313975
Recruitment Status : Completed
First Posted : March 14, 2011
Last Update Posted : April 17, 2013
Foundation for research in Anaesthesie and Intensive Care Medicine
Brahms AG
Information provided by:
University Hospital Inselspital, Berne

Brief 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.

Condition or disease
Electrolyte Disturbances Subarachnoid Hemorrhage Traumatic Brain Injury Natriuretic Peptides

Detailed Description:


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
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
Study Start Date : January 2011
Actual Primary Completion Date : January 2013
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

Patients with non-traumatic subarachnoid hemorrhage
Patients with severe traumatic brain injury

Primary Outcome Measures :
  1. Incidence of sodium-fluid disturbances [ Time Frame: 14 days ]

Secondary Outcome Measures :
  1. Type of sodium abnormality [ Time Frame: 14 days ]
  2. 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

  3. Associated changes in natriuretic peptide levels [ Time Frame: 14 days ]

Biospecimen Retention:   Samples With DNA
serum and urine samples

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Intenisve Care Medicine patients with non-traumatic subarachnoid hemorrhage or severe traumatic brain injury

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT01313975

Dep. of Intensive Care Medicine Bern University Hospital
Bern, Switzerland, 3010
Sponsors and Collaborators
University Hospital Inselspital, Berne
Foundation for research in Anaesthesie and Intensive Care Medicine
Brahms AG
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

Responsible Party: Jan Wiegand, MD, Department of Intensive Care Medicine University Hospital Bern, Switzerland Identifier: NCT01313975     History of Changes
Other Study ID Numbers: 203/10
First Posted: March 14, 2011    Key Record Dates
Last Update Posted: April 17, 2013
Last Verified: April 2013

Keywords provided by University Hospital Inselspital, Berne:
Electrolyte disturbances
Fluid balance
subarachnoid hemorrhage
traumatic brain injury
Cerebral salt wasting
Diabetes insipidus

Additional relevant MeSH terms:
Wounds and Injuries
Brain Injuries
Brain Injuries, Traumatic
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