Electrolyte and Fluid Disturbances in Subarachnoid Hemorrhage and Traumatic Brain Injury

NCT ID: NCT01313975

Last Updated: 2013-04-17

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 85 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2013-01-31

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.

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

Conditions

Electrolyte Disturbances; Subarachnoid Hemorrhage; Traumatic Brain Injury; Natriuretic Peptides

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

1

Patients with non-traumatic subarachnoid hemorrhage

No interventions assigned to this group

2

Patients with severe traumatic brain injury

No interventions assigned to this group

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Foundation for research in Anaesthesie and Intensive Care Medicine

UNKNOWN

Sponsor Role: collaborator

Brahms AG

INDUSTRY

Sponsor Role: collaborator

Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role: lead

Responsible Party

Department of Intensive Care Medicine University Hospital Bern, Switzerland

Principal Investigators

Jan Wiegand, MD

Role: PRINCIPAL_INVESTIGATOR

Dep. Intensive Care Medicine, University Hospitals Bern

Stephan Jakob, MD, PhD

Role: STUDY_DIRECTOR

Dep. Intensive Care Medicine, University Hospitals Bern

Jukka Takala, MD PhD

Role: STUDY_CHAIR

Dep. Intensive Care Medicine, University Hospitals Bern

Locations

Dep. of Intensive Care Medicine Bern University Hospital

Bern, , Switzerland

Countries

Switzerland

Other Identifiers

203/10

Identifier Type: -

Identifier Source: org_study_id