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The "COSMOS"-Study (Copeptin in Osmoregulation and Stress Assessment)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00390962
First Posted: October 23, 2006
Last Update Posted: September 23, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University Hospital, Basel, Switzerland
  Purpose

Sodium imbalance is common and an adverse prognostic factor in hospitalized patients. However, identifying the causes of sodium imbalance is challenging in clinical practice. Levels of antidiuretic hormone (ADH) are elevated in patients with stroke correlating with disease severity and stress level; however, its measurement is cumbersome. ADH is derived from a larger precursor peptide along with Copeptin, which is a more stable peptide directly mirroring the production of ADH. Copeptin can be assayed readily in plasma. Early prognostic factors to predict in-hospital mortality and medium/long-term outcome in critically ill neurological patients, are helpful to guide and tailor early decisions on treatment, discharge from the intensive care unit and application of interventions to prevent deterioration of neurological functions.

We hypothesize that copeptin will improve the diagnostic accuracy to diagnose sodium imbalances as compared to routinely used markers Furthermore, we hypothesize that Copeptin will be a reliable prognostic tool, dependent or independent of sodium imbalance, to predict short-term (i.e. in-hospital) and medium-term (i.e. 3 months) clinical outcome in stroke patients.


Condition
Stroke Transient Ischemic Attack

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Copeptin as a Novel Diagnostic and Prognostic Marker in the Management of Neurological and Neurosurgical Patients With Sodium Imbalance The "COSMOS"-Study (Copeptin in Osmoregulation and Stress Assessment)

Resource links provided by NLM:


Further study details as provided by University Hospital, Basel, Switzerland:

Biospecimen Retention:   Samples Without DNA
bood sampling

Enrollment: 469
Study Start Date: November 2006
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All consecutive patients who are admitted to the emergency department with an ischemic or hemorrhagic stroke or transient ischemic attach (TIA) according to the World Health organization criteria [37] with symptom onset within the last 3 days.
Criteria

Inclusion Criteria:

  1. All consecutive patients who are admitted to the emergency department with an ischemic or hemorrhagic stroke or transient ischemic attach (TIA) according to the World Health organization criteria [37] with symptom onset within the last 3 days.
  2. All consecutive patients who undergo intracranial surgery due to

    • pituitary tumors
    • intracerebral hemorrhage (ICH)
    • subarachnoidal hemorrhage (SAH)
    • chronic subdural hematoma
    • head trauma with contusion cerebri
    • intracranial abcesses

Exclusion Criteria:

  • Patients without informed consent.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00390962


Locations
Switzerland
University Hospital Basel
Basel, BS, Switzerland, 4051
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
Study Chair: Beat Mueller, Prof University Hospital, Basel, Switzerland
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00390962     History of Changes
Other Study ID Numbers: EKBB 157/06
First Submitted: October 20, 2006
First Posted: October 23, 2006
Last Update Posted: September 23, 2008
Last Verified: September 2008

Keywords provided by University Hospital, Basel, Switzerland:
copeptin
vasopressin
Adh
SIADH
diabetes insipidus
stroke
risk factors
Neurological patients with ischemic and hemorrhagic stroke and patients undergoing intracranial surgery.

Additional relevant MeSH terms:
Diabetes Insipidus
Ischemic Attack, Transient
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Kidney Diseases
Urologic Diseases
Pituitary Diseases
Endocrine System Diseases
Arginine Vasopressin
Hemostatics
Coagulants
Vasoconstrictor Agents
Antidiuretic Agents
Natriuretic Agents
Physiological Effects of Drugs