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ISRCTN
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ISRCTN48080544
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ClinicalTrials.gov identifier
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Public title
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Copeptin as a novel diagnostic and prognostic marker in the management of neurological and neurosurgical patients with sodium imbalance
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Scientific title
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Acronym
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COSMOS - (Copeptin in OSMOregulation and Stress assessment)
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Serial number at source
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157/06
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Study hypothesis
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Sodium imbalance is common and an adverse prognostic factor in hospitalised patients. However, identifying the causes of sodium imbalance is challenging in clinical practice. Levels of Anti-Diuretic 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.
The aim of this trial is to evaluate Copeptin as a diagnostic tool in disturbances of water homeostasis and prognostic tool to predict outcome in a well-defined cohort of stroke patients and patients undergoing intracranial surgery.
Study hypotheses:
1. Copeptin will improve the diagnostic accuracy to diagnose sodium imbalances as compared to routinely used markers.
2. 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. three months) clinical outcome in stroke patients.
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Lay summary
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Ethics approval
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The study has been approved by the local ethical review board (Ethics Committee of Basel [EKBB] ref. no.: 157/06).
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Study design
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Prospective, observational study.
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Countries of recruitment
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Switzerland
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Disease/condition/study domain
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Sodium imbalance
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Participants - inclusion criteria
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1. All consecutive patients who are admitted to the emergency department with an ischaemic or haemorrhagic stroke or Transient Ischaemic Attack (TIA) according to the World Health Organization criteria with symptom onset within the last three days
2. All consecutive patients who undergo intracranial surgery due to:
a. pituitary tumors
b. IntraCerebral Haemorrhage (ICH)
c. SubArachnoidal Haemorrhage (SAH)
d. chronic subdural haematoma
e. head trauma with contusio cerebri
f. intracranial abcesses
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Participants - exclusion criteria
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Patients without informed consent
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Anticipated start date
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06/11/2006
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Anticipated end date
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06/11/2007
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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400 - 500
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Interventions
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After informed consent, all routinely determined baseline data will be assessed including medical history, clinical items (i.e. neurological status, volume status, pulse rate, blood pressure, weight) and laboratory items (i.e. urine/serum osmolality, electrolytes, among others). All patients will have a follow-up with clinical and laboratory assessment until the day of discharge.
After three months, they will be followed-up by a structured telephone interview to assess outcome (mortality, morbidity, as assessed by the Modified Rankin Scale and Barthel index). Copeptin will be assessed in a batch analysis upon completion of the plasma asseveration.
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Primary outcome measure(s)
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1. Copeptin will improve the diagnostic accuracy to diagnose sodium imbalances as compared to routinely used markers (gold standard) and algorithms.
2. 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. three months) clinical outcome in stroke patients.
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Secondary outcome measure(s)
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1. Comparison of copeptin with other risk scores and factors (cerebrovascular, National Institute of Health and Stroke Scale [NIHSS])
2. Comparison of copeptin with other biomarkers (Brain Natriuretic Peptide [BNP], Procalcitonin [PCT], endothelin) in light of the first endpoint
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Sources of funding
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Privately funded trial by the Principal Investigator of this trial.
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Trial website
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Publications
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Contact name
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Dr
Mira
Katan
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Address
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Division of Endocrinology, Diabetes and Clinical Nutrition
University Hospital Basel
Petersgraben 4
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City/town
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Basel
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Zip/Postcode
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4051
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Country
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Switzerland
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Tel
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+41 (0)61 265 2525
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Fax
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+41 (0)61 265 5100
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Email
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katanm@uhbs.ch
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Sponsor
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University Hospital Basel (Switzerland)
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Address
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c/o Professor Beat Mueller
Division of Endocrinology
Diabetes and Clinical Nutrition
Petersgraben 4
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City/town
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Basel
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Zip/Postcode
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4031
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Country
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Switzerland
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Tel
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+41 (0)61 265 2525
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Fax
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+41 (0)61 265 5100
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Email
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happy.mueller@unibas.ch
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Sponsor website:
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http://www.universitaetsspital-basel.ch/#
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Date applied
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11/10/2006
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Last edited
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19/09/2007
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Date ISRCTN assigned
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21/11/2006
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