StrokeNCT00390962
The "COSMOS"-Study (Copeptin in Osmoregulation and Stress Assessment)
An observational study of Stroke and Transient Ischemic Attack, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
Sodium imbalance is common and an adverse prognostic factor in hospitalized patients. However, identifying the causes of sodium imbalance is challenging in clinical practice. Levels of antidiuretic hormone (ADH) are elevated in patients with stroke correlating with disease severity and stress level; however, its… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stroke, Transient Ischemic Attack
- How many people
- 469 participants
- Where
- 1 siteSwitzerland
- Study dates
- Nov 2006to Mar 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All consecutive patients who are admitted to the emergency department with an ischemic or hemorrhagic stroke or transient ischemic attach (TIA) according to the World Health organization criteria [37] with symptom onset within the last 3 days.
Who may be able to join
- All consecutive patients who are admitted to the emergency department with an ischemic or hemorrhagic stroke or transient ischemic attach (TIA) according to the World Health organization criteria [37] with symptom onset within the last 3 days.
- All consecutive patients who undergo intracranial surgery due to
- pituitary tumors
- intracerebral hemorrhage (ICH)
- subarachnoidal hemorrhage (SAH)
- chronic subdural hematoma
- head trauma with contusion cerebri
- intracranial abcesses
Who cannot join
- Patients without informed consent.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Basel
Basel, Canton of Basel-City, 4051
About this study
Official title: Copeptin as a Novel Diagnostic and Prognostic Marker in the Management of Neurological and Neurosurgical Patients With Sodium Imbalance The "COSMOS"-Study (Copeptin in Osmoregulation and Stress Assessment)
Sodium imbalance is common and an adverse prognostic factor in hospitalized patients. However, identifying the causes of sodium imbalance is challenging in clinical practice. Levels of antidiuretic 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.
We hypothesize that copeptin will improve the diagnostic accuracy to diagnose sodium imbalances as compared to routinely used markers Furthermore, we hypothesize that 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. 3 months) clinical outcome in stroke patients.
Read the detailed description
Background:
Sodium imbalance is common and an adverse prognostic factor in hospitalized patients. However, identifying the causes of sodium imbalance is challenging in clinical practice. Levels of antidiuretic 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.
Aim: 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.
Design: Prospective, observational study. Location Setting: Emergency and neurological and neurosurgical clinic of the University Hospital of Basel.
Patients: Neurological patients with ischemic and hemorrhagic stroke and patients undergoing intracranial surgery.
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 3 months, they will be followed-up by a structured telephone interview to assess outcome (mortality, morbidity, as assessed by the ranking scale and Barthel index). Copeptin will be assessed in a batch analysis upon completion of the plasma asseveration.
Variables and measurements: Baseline data on medical history and clinical items, co-morbidities and treatment procedures will be collected. This exploratory study will be conducted over a 12 month period from November 2006 to November 2007.
Study hypothesis: 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. 3 months) clinical outcome in stroke patients.
Analysis: Our sample size consideration is based on the second prognostic question to predict the outcome of neurological and neurosurgical patients. To determine an optimal clinical model we will undertake a multivariable regression analysis to assess which variables are independently associated with outcome. Multiple regression models with a minimum of 10 to 15 observations per predictor variable reveal good estimates. We will evaluate 18 predictors in our multivariate analysis. Therefore, we aim to include a minimum sample size of 180 patients (for 10 observations per predictor) to 270 (for 15 observations per predictor) and a maximum sample size of 360 patients (for 20 observations per predictor).
Significance: Despite the frequent occurrence and the poor outcomes of serious disorders of sodium balance, few controlled data are available to guide the clinician. A better diagnostic approach to determine the etiology of hyponatremia should improve patient management. Copeptin as a prognostic marker in neurological and neurosurgical patients could become an innovative tool to guide early treatment decisions, discharge from the stroke unit and application of interventions.
- Conditions
- Stroke, Transient Ischemic Attack
- Keywords
- copeptin, vasopressin, Adh, SIADH, diabetes insipidus, stroke, risk factors, Neurological patients with ischemic and hemorrhagic stroke and patients undergoing intracranial surgery.
- Medical subject headings
- Stroke, Ischemic Attack, Transient, Diabetes Insipidus, Carcinoma, Intraductal, Noninfiltrating, Inappropriate ADH Syndrome, Hemorrhagic Stroke
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2006 (estimated)
- Study startNov 2006
- Primary completionMar 2008
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 469 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Investigators
- Beat Mueller, Prof, Study chair, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00390962
- Sponsor's protocol ID
- EKBB 157/06
- Status last verified
- Sep 2008
- First submitted
- 20 Oct 2006
- Last updated
- 23 Sep 2008
- Results posted
- No
Publications
Schweizer J, Bustamante A, Lapierre-Fetaud V, Faura J, Scherrer N, Azurmendi Gil L, Fluri F, Schutz V, Luft A, Boned S, Sanchez JC, Montaner J, Katan M. SAA (Serum Amyloid A): A Novel Predictor of Stroke-Associated Infections. Stroke. 2020 Dec;51(12):3523-3530. doi: 10.1161/STROKEAHA.120.030064. Epub 2020 Nov 9.
PubMed 33161846De Marchis GM, Dankowski T, Konig IR, Fladt J, Fluri F, Gensicke H, Foerch C, Findling O, Kurmann R, Fischer U, Luft A, Buhl D, Engelter ST, Lyrer PA, Christ-Crain M, Arnold M, Katan M. A novel biomarker-based prognostic score in acute ischemic stroke: The CoRisk score. Neurology. 2019 Mar 26;92(13):e1517-e1525. doi: 10.1212/WNL.0000000000007177. Epub 2019 Mar 1.
PubMed 30824558Nigro N, Wildi K, Mueller C, Schuetz P, Mueller B, Fluri F, Christ-Crain M, Katan M. BNP but Not s-cTnln is associated with cardioembolic aetiology and predicts short and long term prognosis after cerebrovascular events. PLoS One. 2014 Jul 29;9(7):e102704. doi: 10.1371/journal.pone.0102704. eCollection 2014.
PubMed 25072816Frontzek K, Fluri F, Siemerkus J, Muller B, Gass A, Christ-Crain M, Katan M. Isolated insular strokes and plasma MR-proANP levels are associated with newly diagnosed atrial fibrillation: a pilot study. PLoS One. 2014 Mar 19;9(3):e92421. doi: 10.1371/journal.pone.0092421. eCollection 2014.
PubMed 24647802Blum CA, Mueller C, Schuetz P, Fluri F, Trummler M, Mueller B, Katan M, Christ-Crain M. Prognostic value of dehydroepiandrosterone-sulfate and other parameters of adrenal function in acute ischemic stroke. PLoS One. 2013 May 1;8(5):e63224. doi: 10.1371/journal.pone.0063224. Print 2013.
PubMed 23650556Zweifel C, Katan M, Schuetz P, Ernst A, Mariani L, Muller B, Christ-Crain M. Growth hormone and outcome in patients with intracerebral hemorrhage: a pilot study. Biomarkers. 2011 Sep;16(6):511-6. doi: 10.3109/1354750X.2011.599074. Epub 2011 Aug 3.
PubMed 21812576Katan M, Fluri F, Schuetz P, Morgenthaler NG, Zweifel C, Bingisser R, Kappos L, Steck A, Engelter ST, Muller B, Christ-Crain M. Midregional pro-atrial natriuretic peptide and outcome in patients with acute ischemic stroke. J Am Coll Cardiol. 2010 Sep 21;56(13):1045-53. doi: 10.1016/j.jacc.2010.02.071.
PubMed 20846604Urwyler SA, Schuetz P, Fluri F, Morgenthaler NG, Zweifel C, Bergmann A, Bingisser R, Kappos L, Steck A, Engelter S, Muller B, Christ-Crain M, Katan M. Prognostic value of copeptin: one-year outcome in patients with acute stroke. Stroke. 2010 Jul;41(7):1564-7. doi: 10.1161/STROKEAHA.110.584649. Epub 2010 May 27.
PubMed 20508186
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Copeptin as a Novel Diagnostic and Prognostic Marker in the Management of Neurological and Neurosurgical Patients With Sodium Imbalance The "COSMOS"-Study (Copeptin in Osmoregulation and Stress Assessment)
- ClinicalTrials.gov ID
- NCT00390962
- Acronym / sponsor ID
- EKBB 157/06
- Conditions
- Stroke, Transient Ischemic Attack
- Keywords
- copeptin, vasopressin, Adh, SIADH, diabetes insipidus, stroke, risk factors, Neurological patients with ischemic and hemorrhagic stroke and patients undergoing intracranial surgery.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 469 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- Nov 2006
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 23 Oct 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Sodium imbalance is common and an adverse prognostic factor in hospitalized patients. However, identifying the causes of sodium imbalance is challenging in clinical practice. Levels of antidiuretic 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.
We hypothesize that copeptin will improve the diagnostic accuracy to diagnose sodium imbalances as compared to routinely used markers Furthermore, we hypothesize that 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. 3 months) clinical outcome in stroke patients.
Detailed description
Background:
Sodium imbalance is common and an adverse prognostic factor in hospitalized patients. However, identifying the causes of sodium imbalance is challenging in clinical practice. Levels of antidiuretic 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.
Aim: 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.
Design: Prospective, observational study. Location Setting: Emergency and neurological and neurosurgical clinic of the University Hospital of Basel.
Patients: Neurological patients with ischemic and hemorrhagic stroke and patients undergoing intracranial surgery.
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 3 months, they will be followed-up by a structured telephone interview to assess outcome (mortality, morbidity, as assessed by the ranking scale and Barthel index). Copeptin will be assessed in a batch analysis upon completion of the plasma asseveration.
Variables and measurements: Baseline data on medical history and clinical items, co-morbidities and treatment procedures will be collected. This exploratory study will be conducted over a 12 month period from November 2006 to November 2007.
Study hypothesis: 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. 3 months) clinical outcome in stroke patients.
Analysis: Our sample size consideration is based on the second prognostic question to predict the outcome of neurological and neurosurgical patients. To determine an optimal clinical model we will undertake a multivariable regression analysis to assess which variables are independently associated with outcome. Multiple regression models with a minimum of 10 to 15 observations per predictor variable reveal good estimates. We will evaluate 18 predictors in our multivariate analysis. Therefore, we aim to include a minimum sample size of 180 patients (for 10 observations per predictor) to 270 (for 15 observations per predictor) and a maximum sample size of 360 patients (for 20 observations per predictor).
Significance: Despite the frequent occurrence and the poor outcomes of serious disorders of sodium balance, few controlled data are available to guide the clinician. A better diagnostic approach to determine the etiology of hyponatremia should improve patient management. Copeptin as a prognostic marker in neurological and neurosurgical patients could become an innovative tool to guide early treatment decisions, discharge from the stroke unit and application of interventions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All consecutive patients who are admitted to the emergency department with an ischemic or hemorrhagic stroke or transient ischemic attach (TIA) according to the World Health organization criteria [37] with symptom onset within the last 3 days.
Key inclusion criteria (8 listed)
- All consecutive patients who are admitted to the emergency department with an ischemic or hemorrhagic stroke or transient ischemic attach (TIA) according to the World Health organization criteria [37] with symptom onset within the last 3 days.
- All consecutive patients who undergo intracranial surgery due to
Key exclusion criteria (1 listed)
- Patients without informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2008.
- Derived from this study: PubMed 33161846Schweizer J, Bustamante A, Lapierre-Fetaud V, Faura J, Scherrer N, Azurmendi Gil L, Fluri F, Schutz V, Luft A, Boned S, Sanchez JC, Montaner J, Katan M. SAA (Serum Amyloid A): A Novel Predictor of Stroke-Associated Infections. Stroke. 2020 Dec;51(12):3523-3530. doi: 10.1161/STROKEAHA.120.030064. Epub 2020 Nov 9.
- Derived from this study: PubMed 30824558De Marchis GM, Dankowski T, Konig IR, Fladt J, Fluri F, Gensicke H, Foerch C, Findling O, Kurmann R, Fischer U, Luft A, Buhl D, Engelter ST, Lyrer PA, Christ-Crain M, Arnold M, Katan M. A novel biomarker-based prognostic score in acute ischemic stroke: The CoRisk score. Neurology. 2019 Mar 26;92(13):e1517-e1525. doi: 10.1212/WNL.0000000000007177. Epub 2019 Mar 1.
- Derived from this study: PubMed 25072816Nigro N, Wildi K, Mueller C, Schuetz P, Mueller B, Fluri F, Christ-Crain M, Katan M. BNP but Not s-cTnln is associated with cardioembolic aetiology and predicts short and long term prognosis after cerebrovascular events. PLoS One. 2014 Jul 29;9(7):e102704. doi: 10.1371/journal.pone.0102704. eCollection 2014.
- Derived from this study: PubMed 24647802Frontzek K, Fluri F, Siemerkus J, Muller B, Gass A, Christ-Crain M, Katan M. Isolated insular strokes and plasma MR-proANP levels are associated with newly diagnosed atrial fibrillation: a pilot study. PLoS One. 2014 Mar 19;9(3):e92421. doi: 10.1371/journal.pone.0092421. eCollection 2014.
- Derived from this study: PubMed 23650556Blum CA, Mueller C, Schuetz P, Fluri F, Trummler M, Mueller B, Katan M, Christ-Crain M. Prognostic value of dehydroepiandrosterone-sulfate and other parameters of adrenal function in acute ischemic stroke. PLoS One. 2013 May 1;8(5):e63224. doi: 10.1371/journal.pone.0063224. Print 2013.
- Derived from this study: PubMed 21812576Zweifel C, Katan M, Schuetz P, Ernst A, Mariani L, Muller B, Christ-Crain M. Growth hormone and outcome in patients with intracerebral hemorrhage: a pilot study. Biomarkers. 2011 Sep;16(6):511-6. doi: 10.3109/1354750X.2011.599074. Epub 2011 Aug 3.
- Derived from this study: PubMed 20846604Katan M, Fluri F, Schuetz P, Morgenthaler NG, Zweifel C, Bingisser R, Kappos L, Steck A, Engelter ST, Muller B, Christ-Crain M. Midregional pro-atrial natriuretic peptide and outcome in patients with acute ischemic stroke. J Am Coll Cardiol. 2010 Sep 21;56(13):1045-53. doi: 10.1016/j.jacc.2010.02.071.
- Derived from this study: PubMed 20508186Urwyler SA, Schuetz P, Fluri F, Morgenthaler NG, Zweifel C, Bergmann A, Bingisser R, Kappos L, Steck A, Engelter S, Muller B, Christ-Crain M, Katan M. Prognostic value of copeptin: one-year outcome in patients with acute stroke. Stroke. 2010 Jul;41(7):1564-7. doi: 10.1161/STROKEAHA.110.584649. Epub 2010 May 27.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Beat Mueller, Prof study chair
University Hospital, Basel, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Transient Ischemic Attack, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00390962, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2008.