Copeptin as a novel diagnostic and prognostic marker in the management of neurological and neurosurgical patients with sodium imbalance
| ISRCTN | ISRCTN48080544 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN48080544 |
| ClinicalTrials.gov number | NCT00390962 |
| Secondary identifying numbers | 157/06 |
- Submission date
- 11/10/2006
- Registration date
- 21/11/2006
- Last edited
- 02/09/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Mira Katan
Scientific
Scientific
Division of Endocrinology, Diabetes and Clinical Nutrition
University Hospital Basel
Petersgraben 4
Basel
4051
Switzerland
| Phone | +41 (0)61 265 2525 |
|---|---|
| katanm@uhbs.ch |
Study information
| Study design | Prospective, observational study. |
|---|---|
| Primary study design | Observational |
| Secondary study design | Case-control study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Scientific title | Copeptin as a novel diagnostic and prognostic marker in the management of neurological and neurosurgical patients with sodium imbalance |
| Study acronym | COSMOS - (Copeptin in OSMOregulation and Stress assessment) |
| Study objectives | 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(s) | The study has been approved by the local ethical review board (Ethics Committee of Basel [EKBB] ref. no.: 157/06). |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 06/11/2006 |
| Completion date | 06/11/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 400 - 500 |
| Key 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 |
| Key exclusion criteria | Patients without informed consent |
| Date of first enrolment | 06/11/2006 |
| Date of final enrolment | 06/11/2007 |
Locations
Countries of recruitment
- Switzerland
Study participating centre
Division of Endocrinology, Diabetes and Clinical Nutrition
Basel
4051
Switzerland
4051
Switzerland
Sponsor information
University Hospital Basel (Switzerland)
Hospital/treatment centre
Hospital/treatment centre
c/o Professor Beat Mueller
Division of Endocrinology
Diabetes and Clinical Nutrition
Petersgraben 4
Basel
4031
Switzerland
| Phone | +41 (0)61 265 2525 |
|---|---|
| happy.mueller@unibas.ch | |
| Website | http://www.universitaetsspital-basel.ch/# |
"ROR" |
https://ror.org/04k51q396 |
Funders
Funder type
Other
Privately funded trial by the Principal Investigator of this trial.
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 01/12/2009 | 02/09/2021 | Yes | No | |
| Results article | 21/09/2010 | 02/09/2021 | Yes | No | |
| Results article | 01/05/2013 | 02/09/2021 | Yes | No | |
| Results article | 29/07/2014 | 02/09/2021 | Yes | No |
Editorial Notes
02/09/2021: Publication references and ClinicalTrials.gov number added.
