Electrolyte and Fluid Disturbances in Subarachnoid Hemorrhage and Traumatic Brain Injury

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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:

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

Study Design

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Groups and Cohorts

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
1; Patients with non-traumatic subarachnoid hemorrhage
2; Patients with severe traumatic brain injury

Outcome Measures

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Eligibility Criteria

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years and older (Adult, Senior)
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

Criteria

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 Locations

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Switzerland
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

Investigators

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

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations 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
First Posted:	March 14, 2011
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; SIADH; Diabetes insipidus

Additional relevant MeSH terms:

Wounds and Injuries; Brain Injuries; Hemorrhage; 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