Ignite Creation Date:
2024-05-05 @ 5:08 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00390962
Status:
COMPLETED
Last Update Posted:
2008-09-23
First Post:
2006-10-20
Brief Title:
The COSMOS-Study Copeptin in Osmoregulation and Stress Assessment
Sponsor:
University Hospital Basel Switzerland
Organization:
University Hospital Basel Switzerland
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2008-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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 mediumlong-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 ie in-hospital and medium-term ie 3 months clinical outcome in stroke patients
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 ie in-hospital and medium-term ie 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 mediumlong-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 ie neurological status volume status pulse rate blood pressure weight and laboratory items ie 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 ie in-hospital and medium-term ie 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
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 mediumlong-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 ie neurological status volume status pulse rate blood pressure weight and laboratory items ie 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 ie in-hospital and medium-term ie 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None