Copeptin as a novel diagnostic and prognostic marker in the management of neurological and neurosurgical patients with sodium imbalance

Not Applicable

Completed

• Conditions: Electrolyte disorders; Sodium imbalance; Nutritional, Metabolic, Endocrine

• Registration Number: ISRCTN48080544
• Lead Sponsor: niversity Hospital Basel (Switzerland)

Brief Summary

2009 Results article in https://pubmed.ncbi.nlm.nih.gov/20035506/ (added 02/09/2021) 2010 Results article in https://pubmed.ncbi.nlm.nih.gov/20846604/ (added 02/09/2021) 2013 Results article in https://pubmed.ncbi.nlm.nih.gov/23650556/ (added 02/09/2021) 2014 Results article in https://pubmed.ncbi.nlm.nih.gov/25072816/ (added 02/09/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-11-21
• Study Completion: 2007-11-06
• Last Update Posted: 13 September 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 500

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

Exclusion Criteria

Patients without informed consent

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. Copeptin will improve the diagnostic accuracy to diagnose sodium imbalances as compared to routinely used markers (gold standard) and algorithms.<br> 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.<br>

Secondary Outcome Measures

Name	Time	Method
<br> 1. Comparison of copeptin with other risk scores and factors (cerebrovascular, National Institute of Health and Stroke Scale [NIHSS])<br> 2. Comparison of copeptin with other biomarkers (Brain Natriuretic Peptide [BNP], Procalcitonin [PCT], endothelin) in light of the first endpoint<br>