SepsisPCTNCT01362920
Diagnostic and Prognostic Value of Serial Procalcitonin (PCT) Measurements in Critically Ill Patients
An observational study of Sepsis, run by The Cleveland Clinic at 1 site in United States.
Trial summary
In 2005, the Food and Drug Administration (FDA) approved procalcitonin in conjunction with other laboratory markers to aid in the risk assessment of critically ill patients with severe infection (sepsis). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Sepsis
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2011to Nov 2012
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Prospective-observational study design in which a PCT measurement will be obtained on admission to the Medical Intensive Care Unit (MICU) and then daily (as clinically available)until discharge from the unit or death.
Who may be able to join
- All consecutive patients admitted to the Medical Intensive Care Unit of the Cleveland Clinic with an anticipated MICU stay of ≥ 12hrs
Who cannot join
- Age less than 18-years of age and/or an expected MICU stay of less than 12-hrs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diagnostic and Prognostic Value of Serial PCT Measurements in Critically Ill Patients
In 2005, the Food and Drug Administration (FDA) approved procalcitonin in conjunction with other laboratory markers to aid in the risk assessment of critically ill patients with severe infection (sepsis). Although considerable literature exists regarding the usefulness of Procalcitonin (PCT) as a marker of sepsis, there are still potential uses for PCT measurements that are not yet explored and its value among the critically ill patients remains unclear. This study seeks to better understand the usefulness of measuring PCT values in patients admitted to the Medical ICU for a variety of reasons and in particular with severe infection (sepsis).
Read the detailed description
Procalcitonin (PCT) is a 116 amino acid peptide that has an approximate MW of 14.5 kDa and belongs to the calcitonin (CT) superfamily of peptides. Transcription of the CALC-1 gene for PCT is usually suppressed in the non-neuroendocrine tissue, except in the C cells of the thyroid gland where its expression produces PCT, the precursor of CT in healthy individuals and in the absence of infection.
In the presence of microbial infection, circulating levels of calcitonin precursors (CTpr), including PCT, increase up to several thousand-fold.1 In addition to being a marker of microbial infection, PCT also acts as a modulator of the host inflammatory reaction. In an animal model of sepsis, administration of exogenous human PCT worsened outcome, whereas neutralization of endogenous PCT improved survival.
There are several inflammatory laboratory markers, like tumor necrosis factor (TNF)-α, interleukin (IL)-1, IL-6 and C-reactive protein (CRP), but they are non- specific for infection and can be caused by conditions like pancreatitis, burns, trauma or acute lung injury. The non-specific nature of clinical and laboratory parameters for microbial infection makes it difficult to evaluate patients with potential infection. In addition to the lack of specificity, traditional laboratory and clinical indicators of sepsis are not temporally concordant with the course of illness. As a result, these tests are not reliable to evaluate the response to therapeutic interventions in real time.
- Conditions
- Sepsis
- Keywords
- Sepsis, Septic shock, Procalcitonin, PCT
- Medical subject headings
- Sepsis, Shock, Septic
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 |
|---|---|---|
| Sepsis or Septic shock cohort | Not described | |
| Non-sepsis or non-Septic shock cohort | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of organ failure
Measured: Current hospitalization (participants will be followed for the duration of hospital stay; an expected average of 7-days)
Development and resolution of shock using a cut-off PCT of >0.5ng/mL
Measured: ICU stay (participants will be followed for the duration of hospital stay; an expected average of 7-days)
ICU and Hospital Mortality
Measured: current hospitalization or 28-day post ICU admission for ICU survivors
Secondary outcomes (1)
Development of hospital acquired infections (catheter related blood stream infection, development of multidrug resistant infections, ventilator associated pneumonia)
Measured: Current hospitalization (participants will be followed for the duration of hospital stay; an expected average of 7-days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2011 (estimated)
- Study startApr 2011
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by The Cleveland 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- BioMérieux
- Responsible party
- Sponsor
- Investigators
- Jorge A Guzman, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01362920
- Sponsor's protocol ID
- PCT-001
- Acronym
- PCT
- Status last verified
- Feb 2013
- First submitted
- 6 Apr 2011
- Last updated
- 18 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic and Prognostic Value of Serial PCT Measurements in Critically Ill Patients
- ClinicalTrials.gov ID
- NCT01362920
- Acronym / sponsor ID
- PCT / PCT-001
- Conditions
- Sepsis
- Keywords
- Sepsis, Septic shock, Procalcitonin, PCT
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Collaborators
- BioMérieux
- Study start
- Apr 2011
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 1 Jun 2011 (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.
In 2005, the Food and Drug Administration (FDA) approved procalcitonin in conjunction with other laboratory markers to aid in the risk assessment of critically ill patients with severe infection (sepsis). Although considerable literature exists regarding the usefulness of Procalcitonin (PCT) as a marker of sepsis, there are still potential uses for PCT measurements that are not yet explored and its value among the critically ill patients remains unclear. This study seeks to better understand the usefulness of measuring PCT values in patients admitted to the Medical ICU for a variety of reasons and in particular with severe infection (sepsis).
Detailed description
Procalcitonin (PCT) is a 116 amino acid peptide that has an approximate MW of 14.5 kDa and belongs to the calcitonin (CT) superfamily of peptides. Transcription of the CALC-1 gene for PCT is usually suppressed in the non-neuroendocrine tissue, except in the C cells of the thyroid gland where its expression produces PCT, the precursor of CT in healthy individuals and in the absence of infection.
In the presence of microbial infection, circulating levels of calcitonin precursors (CTpr), including PCT, increase up to several thousand-fold.1 In addition to being a marker of microbial infection, PCT also acts as a modulator of the host inflammatory reaction. In an animal model of sepsis, administration of exogenous human PCT worsened outcome, whereas neutralization of endogenous PCT improved survival.
There are several inflammatory laboratory markers, like tumor necrosis factor (TNF)-α, interleukin (IL)-1, IL-6 and C-reactive protein (CRP), but they are non- specific for infection and can be caused by conditions like pancreatitis, burns, trauma or acute lung injury. The non-specific nature of clinical and laboratory parameters for microbial infection makes it difficult to evaluate patients with potential infection. In addition to the lack of specificity, traditional laboratory and clinical indicators of sepsis are not temporally concordant with the course of illness. As a result, these tests are not reliable to evaluate the response to therapeutic interventions in real time.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sepsis or Septic shock cohort | – | – |
| Non-sepsis or non-Septic shock cohort | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Prospective-observational study design in which a PCT measurement will be obtained on admission to the Medical Intensive Care Unit (MICU) and then daily (as clinically available)until discharge from the unit or death.
Key inclusion criteria (1 listed)
- All consecutive patients admitted to the Medical Intensive Care Unit of the Cleveland Clinic with an anticipated MICU stay of ≥ 12hrs
Key exclusion criteria (1 listed)
- Age less than 18-years of age and/or an expected MICU stay of less than 12-hrs
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
Development of organ failure
Time frame: Current hospitalization (participants will be followed for the duration of hospital stay; an expected average of 7-days)
Development and resolution of shock using a cut-off PCT of >0.5ng/mL
Time frame: ICU stay (participants will be followed for the duration of hospital stay; an expected average of 7-days)
ICU and Hospital Mortality
Time frame: current hospitalization or 28-day post ICU admission for ICU survivors
1 secondary outcome
Development of hospital acquired infections (catheter related blood stream infection, development of multidrug resistant infections, ventilator associated pneumonia)
Time frame: Current hospitalization (participants will be followed for the duration of hospital stay; an expected average of 7-days)
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 18 Feb 2013.
Related trials for Sepsis
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
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CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
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Not yet recruiting
Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
Acute-on-Chronic Liver Failure (ACLF)
Active, not recruitingPhase 4
Thymosin Alpha 1 and IgM Levels in Sepsis
Sepsis, Septic Shock
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.
Jorge A Guzman, MD principal investigator
The Cleveland 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 Sepsis, run by The Cleveland 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 18 Feb 2013. 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?
Development of organ failure (time frame: Current hospitalization (participants will be followed for the duration of hospital stay; an expected average of 7-days)). The study lists 3 primary outcomes in all. 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 18 Feb 2013.