Electrolyte and Fluid Disturbances in Subarachnoid Hemorrhage and Traumatic Brain Injury

Completed

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

• Registration Number: NCT01313975
• Lead Sponsor: Insel Gruppe AG, University Hospital Bern

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

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-02-21
• Study First Submitted QC: 2011-03-10
• Study First Posted: 2011-03-14
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-16
• Last Update Posted: 2013-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 85

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of sodium-fluid disturbances	14 days

Secondary Outcome Measures

Name	Time	Method
Type of sodium abnormality	14 days
Associated changes in natriuretic peptide levels	14 days
Haemodynamic changes, 8hourly urine output, 8hourly fluid and sodium balance, changes in fluid management by treating doctors associated with sodium disturbances	14 days	We measure all parameters for multivariate analysis to find common predictors for sodium and fluid balance disturbances in these patients

Trial Locations

Locations (1)

Dep. of Intensive Care Medicine Bern University Hospital; 🇨🇭 Bern, Switzerland