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NCT Number: NCT01313975

Electrolyte and Fluid Disturbances in Subarachnoid Hemorrhage and Traumatic Brain Injury

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.

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Key information

Conditions

Electrolyte Disturbances Brain Diseases Brain Injuries Brain Injuries, Traumatic Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Craniocerebral Trauma Diabetes Insipidus Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hemorrhage Hypothalamic Diseases Inappropriate ADH Syndrome Intracranial Hemorrhages Kidney Diseases Male Urogenital Diseases Metabolic Diseases Natriuretic Peptides Nervous System Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pituitary Diseases Subarachnoid Hemorrhage Trauma, Nervous System Traumatic Brain Injury Urogenital Diseases Urologic Diseases Vascular Diseases Water-Electrolyte Imbalance Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Dep. of Intensive Care Medicine Bern University Hospital

Bern, 3010, Switzerland

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Incidence of sodium-fluid disturbances

    Time frame: 14 days

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Collaborators

  • Brahms AG
  • Foundation for research in Anaesthesie and Intensive Care Medicine

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Mar 14, 2011
Registry last updated
Apr 17, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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