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)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 469
- 试验地点
- 1
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Patients without informed consent.