NCT00390962

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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
469

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 20, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 23, 2006

Completed
9 days until next milestone

Study Start

First participant enrolled

November 1, 2006

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
Last Updated

September 23, 2008

Status Verified

September 1, 2008

Enrollment Period

1.3 years

First QC Date

October 20, 2006

Last Update Submit

September 22, 2008

Conditions

StrokeTransient Ischemic Attack

Keywords

copeptinvasopressinAdhSIADHdiabetes insipidusstrokerisk factorsNeurological patients with ischemic and hemorrhagic stroke and patients undergoing intracranial surgery.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • Patients without informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Basel

Basel, Canton of Basel-City, 4051, Switzerland

Location

Related Publications (8)

  • 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.

    PMID: 33161846DERIVED

  • De 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.

    PMID: 30824558DERIVED

  • Nigro 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.

    PMID: 25072816DERIVED

  • Frontzek 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.

    PMID: 24647802DERIVED

  • Blum 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.

    PMID: 23650556DERIVED

  • Zweifel 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.

    PMID: 21812576DERIVED

  • Katan 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.

    PMID: 20846604DERIVED

  • Urwyler 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.

    PMID: 20508186DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

bood sampling

MeSH Terms

Conditions

StrokeIschemic Attack, TransientDiabetes InsipidusCarcinoma, Intraductal, NoninfiltratingInappropriate ADH SyndromeHemorrhagic Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesBrain IschemiaKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesPituitary DiseasesEndocrine System DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsBreast Carcinoma In SituCarcinoma in SituNeoplasms, Ductal, Lobular, and MedullaryHypothalamic DiseasesWater-Electrolyte ImbalanceMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Beat Mueller, Prof

    University Hospital, Basel, Switzerland

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 20, 2006

First Posted

October 23, 2006

Study Start

November 1, 2006

Primary Completion

March 1, 2008

Study Completion

March 1, 2008

Last Updated

September 23, 2008

Record last verified: 2008-09

Locations

CH(1)