Electrolyte DisturbancesNCT01313975
Electrolyte and Fluid Disturbances in Subarachnoid Hemorrhage and Traumatic Brain Injury
An observational study of Electrolyte Disturbances and Subarachnoid Hemorrhage, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Electrolyte Disturbances, Subarachnoid Hemorrhage, Traumatic Brain Injury
- How many people
- 85 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2011to Jan 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Intenisve Care Medicine patients with non-traumatic subarachnoid hemorrhage or severe traumatic brain injury
Who may be able to join
- non-traumatic subarachnoid hemorrhage
- severe traumatic brain injury (GCS<9)
Who cannot join
- younger than 18 years
- time to admission after injury or bleed more than 7days
- death expected in less than 12hours
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Dep. of Intensive Care Medicine Bern University Hospital
Bern, 3010
About this study
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
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.
Read the 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
- Keywords
- Electrolyte disturbances, Fluid balance, subarachnoid hemorrhage, traumatic brain injury, Cerebral salt wasting, SIADH, Diabetes insipidus
- Medical subject headings
- Subarachnoid Hemorrhage, Brain Injuries, Traumatic, Inappropriate ADH Syndrome, Diabetes Insipidus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Patients with non-traumatic subarachnoid hemorrhage | |
| 2 | Patients with severe traumatic brain injury |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of sodium-fluid disturbances
Measured: 14 days
Secondary outcomes (3)
Type of sodium abnormality
Measured: 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
Measured: 14 days
Associated changes in natriuretic peptide levels
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2011 (estimated)
- Study startJan 2011
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Electrolyte DisturbancesStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Collaborators
- Foundation for research in Anaesthesie and Intensive Care Medicine, Brahms AG
- Investigators
- Jan Wiegand, MD, Principal investigator, Dep. Intensive Care Medicine, University Hospitals BernStephan Jakob, MD, PhD, Study director, Dep. Intensive Care Medicine, University Hospitals BernJukka Takala, MD PhD, Study chair, Dep. Intensive Care Medicine, University Hospitals Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01313975
- Sponsor's protocol ID
- 203/10
- Status last verified
- Apr 2013
- First submitted
- 21 Feb 2011
- Last updated
- 17 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01313975
- Acronym / sponsor ID
- 203/10
- Conditions
- Electrolyte Disturbances, Subarachnoid Hemorrhage, Traumatic Brain Injury, Natriuretic Peptides
- Keywords
- Electrolyte disturbances, Fluid balance, subarachnoid hemorrhage, traumatic brain injury, Cerebral salt wasting, SIADH, Diabetes insipidus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Collaborators
- Foundation for research in Anaesthesie and Intensive Care Medicine, Brahms AG
- Study start
- Jan 2011
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 14 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Patients with non-traumatic subarachnoid hemorrhage |
| 2 | – | –Patients with severe traumatic brain injury |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Intenisve Care Medicine patients with non-traumatic subarachnoid hemorrhage or severe traumatic brain injury
Key inclusion criteria (2 listed)
- non-traumatic subarachnoid hemorrhage
- severe traumatic brain injury (GCS<9)
Key exclusion criteria (3 listed)
- younger than 18 years
- time to admission after injury or bleed more than 7days
- death expected in less than 12hours
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of sodium-fluid disturbances
Time frame: 14 days
3 secondary outcomes
Type of sodium abnormality
Time frame: 14 days
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
Associated changes in natriuretic peptide levels
Time frame: 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan Wiegand, MD principal investigator
Dep. Intensive Care Medicine, University Hospitals Bern
Stephan Jakob, MD, PhD study director
Dep. Intensive Care Medicine, University Hospitals Bern
Jukka Takala, MD PhD study chair
Dep. Intensive Care Medicine, University Hospitals Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Electrolyte Disturbances and Subarachnoid Hemorrhage, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of sodium-fluid disturbances (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2013.