The Natural History of Procalcitonin in Hemorrhagic Stroke

NCT01498705 | Withdrawn

• 1 other identifier: 1997096
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Approximately 12% of strokes in the United States are hemorrhagic.1 Hemorrhagic stroke can lead to multiple complications including fever that is not infectious. Identifying the cause of fever can help physicians choose the best care for the patient to try and prevent further damage to the already injured brain. Bacterial infection is one possible cause of fever in the stroke patient; however an incorrect diagnosis of infection can lead to unnecessary antibiotic use. Better screening tools for infection are being developed to help fight the problem of antibiotic resistance and unnecessary antibiotic use. Unnecessary use of antibiotics in patients increases the risk of adverse events and overall healthcare costs. Procalcitonin (PCT) is one such screening tool which has been used previously to help tell apart bacterial and nonbacterial causes of infection in other disease states; however, PCT has not been studied in hemorrhagic stroke patients. The purpose of this study is to understand the progress of PCT in hemorrhagic stroke patients in order to see whether PCT can be a useful marker for infection in these patients.

Conditions

Intraventricular Hemorrhage; Intracerebral Hemorrhage

Keywords

Intraventricular Hemorrhage; Intracerebral Hemorrhage; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Procalcitonin Level

Outcome Measures

Primary Outcomes (1)

• Natural progression of PCT following hemorrhagic stroke

  Change in serum PCT level on day 0 (baseline) from serum PCT level day 1, 3, and 5.

Secondary Outcomes (1)

• Markers of infection (if obtained by treating medical team) using SIRS criteria well as cultures.

  From date of enrollment to 28 days or until death or discharge, whichever comes first.

Study Arms (1)

Hemmorhagic Stroke

* Hospitalization for an admitting diagnosis of hemorrhagic stroke admitted to the neurosurgical intensive care unit * Age greater than 18 years * No evidence of ischemic cerebrovascular injury

Other: Procalcitonin level

Interventions

Procalcitonin level OTHER

PCT level upon admission and on days 1, 3, and 5 following baseline level

Hemmorhagic Stroke

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients admitted to the Neurosurgical ICU with a diagnosis of intraventricular or intracerebral hemorrhage

You may qualify if:

• Hospitalization for an admitting diagnosis of hemorrhagic stroke admitted to the neurosurgical intensive care unit
• Age greater than 18 years
• No evidence of ischemic cerebrovascular injury

You may not qualify if:

• Concomitant traumatic brain injury
• Antibiotics on admission to the NICU
• Immunocompromised by chemotherapy or HIV positive or patient with neutropenia (ANC \<1000)
• Women who are pregnant and/or of childbearing age where a pregnancy test has not already occurred

Sponsors & Collaborators

• CAMC Health System: lead

Study Sites (1)

Charleston Area Medical Center

Charleston, West Virginia, 25301, United States

Location

Related Publications (19)

• Roberts RR, Hota B, Ahmad I, Scott RD 2nd, Foster SD, Abbasi F, Schabowski S, Kampe LM, Ciavarella GG, Supino M, Naples J, Cordell R, Levy SB, Weinstein RA. Hospital and societal costs of antimicrobial-resistant infections in a Chicago teaching hospital: implications for antibiotic stewardship. Clin Infect Dis. 2009 Oct 15;49(8):1175-84. doi: 10.1086/605630.

  PMID: 19739972 BACKGROUND

• Meyer BC, Hemmen TM, Jackson CM, Lyden PD. Modified National Institutes of Health Stroke Scale for use in stroke clinical trials: prospective reliability and validity. Stroke. 2002 May;33(5):1261-6. doi: 10.1161/01.str.0000015625.87603.a7.

  PMID: 11988601 BACKGROUND

• Castelli GP, Pognani C, Cita M, Paladini R. Procalcitonin as a prognostic and diagnostic tool for septic complications after major trauma. Crit Care Med. 2009 Jun;37(6):1845-9. doi: 10.1097/CCM.0b013e31819ffd5b.

  PMID: 19384224 BACKGROUND

• O'Grady NP, Barie PS, Bartlett JG, Bleck T, Carroll K, Kalil AC, Linden P, Maki DG, Nierman D, Pasculle W, Masur H; American College of Critical Care Medicine; Infectious Diseases Society of America. Guidelines for evaluation of new fever in critically ill adult patients: 2008 update from the American College of Critical Care Medicine and the Infectious Diseases Society of America. Crit Care Med. 2008 Apr;36(4):1330-49. doi: 10.1097/CCM.0b013e318169eda9.

  PMID: 18379262 RESULT

• Azzimondi G, Bassein L, Nonino F, Fiorani L, Vignatelli L, Re G, D'Alessandro R. Fever in acute stroke worsens prognosis. A prospective study. Stroke. 1995 Nov;26(11):2040-3. doi: 10.1161/01.str.26.11.2040.

  PMID: 7482646 RESULT

• Dietrich WD, Alonso O, Halley M, Busto R. Delayed posttraumatic brain hyperthermia worsens outcome after fluid percussion brain injury: a light and electron microscopic study in rats. Neurosurgery. 1996 Mar;38(3):533-41; discussion 541. doi: 10.1097/00006123-199603000-00023.

  PMID: 8837806 RESULT

• Hong KS, Kang DW, Koo JS, Yu KH, Han MK, Cho YJ, Park JM, Bae HJ, Lee BC. Impact of neurological and medical complications on 3-month outcomes in acute ischaemic stroke. Eur J Neurol. 2008 Dec;15(12):1324-31. doi: 10.1111/j.1468-1331.2008.02310.x.

  PMID: 19049549 RESULT

• Katzan IL, Cebul RD, Husak SH, Dawson NV, Baker DW. The effect of pneumonia on mortality among patients hospitalized for acute stroke. Neurology. 2003 Feb 25;60(4):620-5. doi: 10.1212/01.wnl.0000046586.38284.60.

  PMID: 12601102 RESULT

• Johnston KC, Li JY, Lyden PD, Hanson SK, Feasby TE, Adams RJ, Faught RE Jr, Haley EC Jr. Medical and neurological complications of ischemic stroke: experience from the RANTTAS trial. RANTTAS Investigators. Stroke. 1998 Feb;29(2):447-53. doi: 10.1161/01.str.29.2.447.

  PMID: 9472888 RESULT

• Langhorne P, Stott DJ, Robertson L, MacDonald J, Jones L, McAlpine C, Dick F, Taylor GS, Murray G. Medical complications after stroke: a multicenter study. Stroke. 2000 Jun;31(6):1223-9. doi: 10.1161/01.str.31.6.1223.

  PMID: 10835436 RESULT

• Kilpatrick MM, Lowry DW, Firlik AD, Yonas H, Marion DW. Hyperthermia in the neurosurgical intensive care unit. Neurosurgery. 2000 Oct;47(4):850-5; discussion 855-6. doi: 10.1097/00006123-200010000-00011.

  PMID: 11014424 RESULT

• El-Solh AA, Vora H, Knight PR 3rd, Porhomayon J. Diagnostic use of serum procalcitonin levels in pulmonary aspiration syndromes. Crit Care Med. 2011 Jun;39(6):1251-6. doi: 10.1097/CCM.0b013e31820a942c.

  PMID: 21283001 RESULT

• Assicot M, Gendrel D, Carsin H, Raymond J, Guilbaud J, Bohuon C. High serum procalcitonin concentrations in patients with sepsis and infection. Lancet. 1993 Feb 27;341(8844):515-8. doi: 10.1016/0140-6736(93)90277-n.

  PMID: 8094770 RESULT

• Chalupa P, Beran O, Herwald H, Kasprikova N, Holub M. Evaluation of potential biomarkers for the discrimination of bacterial and viral infections. Infection. 2011 Oct;39(5):411-7. doi: 10.1007/s15010-011-0126-4. Epub 2011 Jul 1.

  PMID: 21720792 RESULT

• Hochreiter M, Kohler T, Schweiger AM, Keck FS, Bein B, von Spiegel T, Schroeder S. Procalcitonin to guide duration of antibiotic therapy in intensive care patients: a randomized prospective controlled trial. Crit Care. 2009;13(3):R83. doi: 10.1186/cc7903. Epub 2009 Jun 3.

  PMID: 19493352 RESULT

• Gendrel D, Bohuon C. Procalcitonin as a marker of bacterial infection. Pediatr Infect Dis J. 2000 Aug;19(8):679-87; quiz 688. doi: 10.1097/00006454-200008000-00001. No abstract available.

  PMID: 10959733 RESULT

• Adams HP Jr, del Zoppo G, Alberts MJ, Bhatt DL, Brass L, Furlan A, Grubb RL, Higashida RT, Jauch EC, Kidwell C, Lyden PD, Morgenstern LB, Qureshi AI, Rosenwasser RH, Scott PA, Wijdicks EF; American Heart Association; American Stroke Association Stroke Council; Clinical Cardiology Council; Cardiovascular Radiology and Intervention Council; Atherosclerotic Peripheral Vascular Disease and Quality of Care Outcomes in Research Interdisciplinary Working Groups. Guidelines for the early management of adults with ischemic stroke: a guideline from the American Heart Association/American Stroke Association Stroke Council, Clinical Cardiology Council, Cardiovascular Radiology and Intervention Council, and the Atherosclerotic Peripheral Vascular Disease and Quality of Care Outcomes in Research Interdisciplinary Working Groups: the American Academy of Neurology affirms the value of this guideline as an educational tool for neurologists. Stroke. 2007 May;38(5):1655-711. doi: 10.1161/STROKEAHA.107.181486. Epub 2007 Apr 12.

  PMID: 17431204 RESULT

• Broderick J, Connolly S, Feldmann E, Hanley D, Kase C, Krieger D, Mayberg M, Morgenstern L, Ogilvy CS, Vespa P, Zuccarello M; American Heart Association; American Stroke Association Stroke Council; High Blood Pressure Research Council; Quality of Care and Outcomes in Research Interdisciplinary Working Group. Guidelines for the management of spontaneous intracerebral hemorrhage in adults: 2007 update: a guideline from the American Heart Association/American Stroke Association Stroke Council, High Blood Pressure Research Council, and the Quality of Care and Outcomes in Research Interdisciplinary Working Group. Stroke. 2007 Jun;38(6):2001-23. doi: 10.1161/STROKEAHA.107.183689. Epub 2007 May 3.

  PMID: 17478736 RESULT

• de Werra I, Jaccard C, Corradin SB, Chiolero R, Yersin B, Gallati H, Assicot M, Bohuon C, Baumgartner JD, Glauser MP, Heumann D. Cytokines, nitrite/nitrate, soluble tumor necrosis factor receptors, and procalcitonin concentrations: comparisons in patients with septic shock, cardiogenic shock, and bacterial pneumonia. Crit Care Med. 1997 Apr;25(4):607-13. doi: 10.1097/00003246-199704000-00009.

  PMID: 9142024 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

3 mL of blood will be obtained for each PCT sample and will be sent to the Virology lab at CAMC Memorial hospital where the serum will be frozen until all samples are collected. After all samples from each of the 30 patients are obtained, the specimens will be analyzed for the PCT value and then discarded.

MeSH Terms

Conditions

Cerebral Hemorrhage; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases

Interventions

Procalcitonin

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Calcitonin; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Protein Precursors; Proteins

Study Officials

• Douglas W Haden, MD

  WVU School of Medicine/Charleston Division

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Pharmacist Specialist

Study Record Dates

• First Submitted: December 20, 2011
• First Posted: December 23, 2011
• Study Start: December 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: December 1, 2012
• Last Updated: February 4, 2014

Record last verified: 2014-01

Locations

US (1)