Electrolyte and Fluid Disturbances in Subarachnoid Hemorrhage and Traumatic Brain Injury

This study has been completed.
Sponsor:
Collaborators:
Foundation for research in Anaesthesie and Intensive Care Medicine
Brahms AG
Information provided by:
University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:
NCT01313975
First received: February 21, 2011
Last updated: April 16, 2013
Last verified: April 2013
  Purpose

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.


Condition
Electrolyte Disturbances
Subarachnoid Hemorrhage
Traumatic Brain Injury
Natriuretic Peptides

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by University Hospital Inselspital, Berne:

Primary Outcome Measures:
  • Incidence of sodium-fluid disturbances [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Type of sodium abnormality [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
    We measure all parameters for multivariate analysis to find common predictors for sodium and fluid balance disturbances in these patients

  • Associated changes in natriuretic peptide levels [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

serum and urine samples


Enrollment: 85
Study Start Date: January 2011
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Patients with non-traumatic subarachnoid hemorrhage
2
Patients with severe traumatic brain injury

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01313975

Locations
Switzerland
Dep. of Intensive Care Medicine Bern University Hospital
Bern, Switzerland, 3010
Sponsors and Collaborators
University Hospital Inselspital, Berne
Foundation for research in Anaesthesie and Intensive Care Medicine
Brahms AG
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
  More Information

No publications provided

Responsible Party: Jan Wiegand, MD, Department of Intensive Care Medicine University Hospital Bern, Switzerland
ClinicalTrials.gov Identifier: NCT01313975     History of Changes
Other Study ID Numbers: 203/10
Study First Received: February 21, 2011
Last Updated: April 16, 2013
Health Authority: Switzerland: Independent Local Research Ethic Commission (Ethikkommission)

Keywords provided by University Hospital Inselspital, Berne:
Electrolyte disturbances
Fluid balance
subarachnoid hemorrhage
traumatic brain injury
Cerebral salt wasting
SIADH
Diabetes insipidus

Additional relevant MeSH terms:
Brain Injuries
Hemorrhage
Subarachnoid Hemorrhage
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 22, 2014