Contact information
Type
Scientific
Primary contact
Dr Mira Katan
ORCID ID
Contact details
Division of Endocrinology
Diabetes and Clinical Nutrition
University Hospital Basel
Petersgraben 4
Basel
4051
Switzerland
+41 (0)61 265 2525
katanm@uhbs.ch
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
157/06
Study information
Scientific title
Acronym
COSMOS - (Copeptin in OSMOregulation and Stress assessment)
Study hypothesis
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.
Ethics approval
The study has been approved by the local ethical review board (Ethics Committee of Basel [EKBB] ref. no.: 157/06).
Study design
Prospective, observational study.
Primary study design
Observational
Secondary study design
Case-control study
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Condition
Sodium imbalance
Intervention
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.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
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.
Secondary outcome measures
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
Overall trial start date
06/11/2006
Overall trial end date
06/11/2007
Reason abandoned
Eligibility
Participant inclusion criteria
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
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
400 - 500
Participant exclusion criteria
Patients without informed consent
Recruitment start date
06/11/2006
Recruitment end date
06/11/2007
Locations
Countries of recruitment
Switzerland
Trial participating centre
Division of Endocrinology, Diabetes and Clinical Nutrition
Basel
4051
Switzerland
Sponsor information
Organisation
University Hospital Basel (Switzerland)
Sponsor details
c/o Professor Beat Mueller
Division of Endocrinology
Diabetes and Clinical Nutrition
Petersgraben 4
Basel
4031
Switzerland
+41 (0)61 265 2525
happy.mueller@unibas.ch
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Other
Funder name
Privately funded trial by the Principal Investigator of this trial.
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary