Condition category
Nutritional, Metabolic, Endocrine
Date applied
11/10/2006
Date assigned
21/11/2006
Last edited
19/09/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.universitaetsspital-basel.ch/#

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

Publication citations

Additional files

Editorial Notes