Electrolyte and Fluid Disturbances in Subarachnoid Hemorrhage and Traumatic Brain Injury

Traumatic Brain Injury Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01313975
• Other study ID #: 203/10
• Status: Completed
• Phase: N/A
• First received: February 21, 2011
• Last updated: April 16, 2013
• Start date: January 2011
• Est. completion date: January 2013

Study information

• Verified date: April 2013
• Source: University Hospital Inselspital, Berne
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Independent Local Research Ethic Commission (Ethikkommission)
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Brain Injuries
• Electrolyte Disturbances
• Hemorrhage
• Natriuretic Peptides
• Subarachnoid Hemorrhage
• Traumatic Brain Injury

Locations

Country	Name	City	State
Switzerland	Dep. of Intensive Care Medicine Bern University Hospital	Bern

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne	Brahms AG, Foundation for research in Anaesthesie and Intensive Care Medicine

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of sodium-fluid disturbances		14 days	No
Secondary	Type of sodium abnormality		14 days	No
Secondary	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	14 days	No
Secondary	Associated changes in natriuretic peptide levels		14 days	No