Subarachnoid Hemorrhage (SAH)NCT00954551
Serum Procalcitonin
An observational study of Subarachnoid Hemorrhage (SAH), run by Mayo Clinic at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Subarachnoid Hemorrhage (SAH)
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to Mar 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- All adult patients admitted for an expected ICU stay of more than 24 hrs over a 6-month period
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Utility of Serum Procalcitonin Levels to Distinguish Systemic Inflammatory Response From Systemic Infection in Febrile Subarachnoid Hemorrhage Patients
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).
Read more
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.
Read the 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,
- Conditions
- Subarachnoid Hemorrhage (SAH)
- Medical subject headings
- Subarachnoid Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
All adult patients admitted for an expected ICU stay of more than 24 hrs over a 6-month period (tentative).
Measured: 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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2009 (estimated)
- Study startJul 2009
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subarachnoid Hemorrhage (SAH)Studies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Investigators
- Emir Festic, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00954551
- Sponsor's protocol ID
- 09-000909
- Status last verified
- Jun 2011
- First submitted
- 5 Aug 2009
- Last updated
- 7 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utility of Serum Procalcitonin Levels to Distinguish Systemic Inflammatory Response From Systemic Infection in Febrile Subarachnoid Hemorrhage Patients
- ClinicalTrials.gov ID
- NCT00954551
- Acronym / sponsor ID
- 09-000909
- Conditions
- Subarachnoid Hemorrhage (SAH)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 7 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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,
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- All adult patients admitted for an expected ICU stay of more than 24 hrs over a 6-month period
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
All adult patients admitted for an expected ICU stay of more than 24 hrs over a 6-month period (tentative).
Time frame: 6 months
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emir Festic, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Subarachnoid Hemorrhage (SAH), run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All adult patients admitted for an expected ICU stay of more than 24 hrs over a 6-month period (tentative). (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2011.