Serum Procalcitonin

This study has been completed.
Sponsor:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00954551
First received: August 5, 2009
Last updated: June 6, 2011
Last verified: June 2011
  Purpose

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.


Condition
Subarachnoid Hemorrhage (SAH)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Utility of Serum Procalcitonin Levels to Distinguish Systemic Inflammatory Response From Systemic Infection in Febrile Subarachnoid Hemorrhage Patients

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • All adult patients admitted for an expected ICU stay of more than 24 hrs over a 6-month period (tentative). [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: July 2009
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

Detailed Description:

Hypothesis: We 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.

Stroke is the third leading cause of death in the United States (AHA), A ruptured brain aneurysm leads to subarachnoid hemorrhage (SAH) which is a common but deadly stroke subtype (8% of all strokes). SAH one-month mortality is at least 30-40% from a combination of complications, being either cerebral (seizures, re-bleeding, hydrocephalus, herniation, coma, brain death) or extra-cerebral (pulmonary edema, myocardial stunning/infarction, hyponatremia, and SIRS). SIRS after subarachnoid hemorrhage is common, and is associated with the increased mortality of SAH (Yoshimoto Y). The pathogenesis remains of SIRS after SAH remains poorly understood, but theorized to be a results of catecholamines (e.g., adrenaline) and interleukins leading to increased heart and respiratory rate, increased peripheral white blood cell count and fever (Wartenberg K). Therefore SIRS after SAH mimics true systemic infection (e.g., sepsis) even when no true infection exists. Lack of treatment of true infection in SAH patients for presumptive non-infective SIRS can lead to missed sepsis and death.

  • A prospective, observational study is proposed
  • PCT levels will be obtained with daily intensive care unit laboratory values on the initial day (day #1), day 3, 5, 7, 9, 11, and 13.
  • Patients with presumed infection will have the following comprehensive assessment per ICU standard of care when a SAH patient has a fever (i.e., temperature 38.5 oral or greater or 38.0 core temperature or greater): two sets of peripheral blood cultures, one cerebrospinal fluid (CSF) culture,
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00954551

Locations
United States, Florida
Mayo Clinic Florida
Jacksonville, Florida, United States, 32224
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Emir Festic, MD Mayo Clinic
  More Information

No publications provided

Responsible Party: Emir Festic, M.D., Mayo Clinic
ClinicalTrials.gov Identifier: NCT00954551     History of Changes
Other Study ID Numbers: 09-000909
Study First Received: August 5, 2009
Last Updated: June 6, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hemorrhage
Subarachnoid Hemorrhage
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 28, 2014