Electrolyte and Fluid Disturbances in Subarachnoid Hemorrhage and Traumatic Brain Injury

Disturbances of the Sodium and Fluid Balance in Patients With Severe Traumatic Brain Injury and Non-traumatic Subarachnoid Hemorrhage. A Systematic Observational Study

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.

Study Overview

• Status: Completed
• Conditions: Traumatic Brain Injury; Subarachnoid Hemorrhage; Natriuretic Peptides; Electrolyte Disturbances

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 Type: Observational
• Enrollment (Actual): 85

Contacts and Locations

Study Locations

• Switzerland
  • Bern, Switzerland, 3010
    • Dep. of Intensive Care Medicine Bern University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Intenisve Care Medicine patients with non-traumatic subarachnoid hemorrhage or severe traumatic brain injury

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of sodium-fluid disturbances	14 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Type of sodium abnormality		14 days
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
Associated changes in natriuretic peptide levels		14 days

Collaborators and Investigators

• Sponsor: University Hospital Inselspital, Berne
• Collaborators: Brahms AG; Foundation for research in Anaesthesie and Intensive Care Medicine
• 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

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (ACTUAL): January 1, 2013
• Study Completion (ACTUAL): January 1, 2013

Study Registration Dates

• First Submitted: February 21, 2011
• First Submitted That Met QC Criteria: March 10, 2011
• First Posted (ESTIMATE): March 14, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): April 17, 2013
• Last Update Submitted That Met QC Criteria: April 16, 2013
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Keywords: subarachnoid hemorrhage; traumatic brain injury; Fluid balance; SIADH; Electrolyte disturbances; Diabetes insipidus; Cerebral salt wasting
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Intracranial Hemorrhages; Brain Injuries; Wounds and Injuries; Hemorrhage; Brain Injuries, Traumatic; Subarachnoid Hemorrhage
• Other Study ID Numbers: 203/10