Serum Procalcitonin

NCT00954551 | Completed

• 1 other identifier: 09-000909
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Systemic inflammatory response syndrome (SIRS) is characterized by changes in body temperature, heart rate, respiratory rate, or peripheral blood white cell count, and is often a heralding manifestation of blood infection (ie., sepsis or bloodstream infection). SIRS however can occur as a result of a stroke without sepsis. When SIRS occurs after stroke, patients are subjected to blood cultures and tests to exclude sepsis, and are often empirically treated with antibiotics potentially leading to a serious gastrointestinal infection called C. difficile enterocolitis, and bacterial antibiotic resistance. Development of a blood test that could provide sufficient sensitivity to exclude blood infection in stroke would therefore prevent numerous tests, cultures, antibiotics, and costs. In recent years, there has been increasing evidence that procalcitonin (PCT) may serve as diagnostic marker to distinguish between infectious and non-infectious SIRS. The investigators hypothesize that PCT can differentiate SIRS after stroke into patients with infection and those without infection. Such screening tests would provide crucial information to clinicians that could improve patient care by reducing the number of tests and antibiotics used, as well as antibiotic-related infections, bacterial resistance and hospital costs. Hypothesis: The investigators hypothesize that PCT can be used to define normal (SIRS without infection) and abnormal values SIRS with infection (i.e., blood, lung, urinary, spinal fluid) in a population of patients with aneurysmal subarachnoid hemorrhage (SAH). Specific Aim 1.) To establish normal values of PCT in patients with aneurysmal subarachnoid hemorrhage and SIRS. Specific Aim 2.) Derive the sensitivity and positive predictive value of abnormal PCT values in patients with aneurysmal SAH, SIRS with true systemic infection.

Conditions

Subarachnoid Hemorrhage (SAH)

Outcome Measures

Primary Outcomes (1)

• All adult patients admitted for an expected ICU stay of more than 24 hrs over a 6-month period (tentative).

  6 months

Secondary Outcomes (1)

• SIRS criteria require 2 or more of the following variables (SCCM reference): 1.) alternations in body temperature 2.) alteration in peripheral white blood cell count 3.) tachycardia 4.) respiratory rate of more than 20 breaths per minute

  1 year

Study Arms (1)

All adult patients with SAH in ICU

All adult patients admitted for an expected ICU stay of more than 24 hrs over a 6-month period (tentative) between xx and xx 2009 with a diagnosis of SAH will be prospectively evaluated.

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

All adult patients admitted for an expected ICU stay of more than 24 hrs over a 6-month period (tentative) between xx and xx 2009 with a diagnosis of SAH will be prospectively evaluated.

You may qualify if:

• All adult patients admitted for an expected ICU stay of more than 24 hrs over a 6-month period

You may not qualify if:

• Patients with known hyper-bilirubinemia (\>0.4 mg/ml) or hypertriglyceridemia (\>10 g/l) will be excluded since this can interfere with measurements of PCT

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic Florida

Jacksonville, Florida, 32224, United States

Location

MeSH Terms

Conditions

Subarachnoid Hemorrhage

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Emir Festic, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: August 5, 2009
• First Posted: August 7, 2009
• Study Start: July 1, 2009
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: June 7, 2011

Record last verified: 2011-06

Locations

US (1)