NCT01313975

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
85

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 21, 2011

Completed
21 days until next milestone

First Posted

Study publicly available on registry

March 14, 2011

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

April 17, 2013

Status Verified

April 1, 2013

Enrollment Period

2 years

First QC Date

February 21, 2011

Last Update Submit

April 16, 2013

Conditions

Electrolyte DisturbancesSubarachnoid HemorrhageTraumatic Brain InjuryNatriuretic Peptides

Keywords

Electrolyte disturbancesFluid balancesubarachnoid hemorrhagetraumatic brain injuryCerebral salt wastingSIADHDiabetes insipidus

Outcome Measures

Primary Outcomes (1)

  • Incidence of sodium-fluid disturbances

    14 days

Secondary Outcomes (3)

  • 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

    14 days

  • Associated changes in natriuretic peptide levels

    14 days

Study Arms (2)

1

Patients with non-traumatic subarachnoid hemorrhage

2

Patients with severe traumatic brain injury

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • non-traumatic subarachnoid hemorrhage
  • severe traumatic brain injury (GCS\<9)

You may not qualify if:

  • younger than 18 years
  • time to admission after injury or bleed more than 7days
  • death expected in less than 12hours

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dep. of Intensive Care Medicine Bern University Hospital

Bern, 3010, Switzerland

Location

Biospecimen

Retention: SAMPLES WITH DNA

serum and urine samples

MeSH Terms

Conditions

Subarachnoid HemorrhageBrain Injuries, TraumaticInappropriate ADH SyndromeDiabetes Insipidus

Condition Hierarchy (Ancestors)

Intracranial HemorrhagesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsBrain InjuriesCraniocerebral TraumaTrauma, Nervous SystemWounds and InjuriesPituitary DiseasesHypothalamic DiseasesWater-Electrolyte ImbalanceMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Jan Wiegand, MD

    Dep. Intensive Care Medicine, University Hospitals Bern

    PRINCIPAL INVESTIGATOR

  • Stephan Jakob, MD, PhD

    Dep. Intensive Care Medicine, University Hospitals Bern

    STUDY DIRECTOR

  • Jukka Takala, MD PhD

    Dep. Intensive Care Medicine, University Hospitals Bern

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 21, 2011

First Posted

March 14, 2011

Study Start

January 1, 2011

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

April 17, 2013

Record last verified: 2013-04

Locations

CH(1)