Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Diagnostic and Prognostic Value of Serial Procalcitonin (PCT) Measurements in Critically Ill Patients (PCT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01362920
Recruitment Status : Completed
First Posted : June 1, 2011
Last Update Posted : February 18, 2013
Sponsor:
Collaborator:
BioMérieux
Information provided by (Responsible Party):
The Cleveland Clinic

Brief 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). 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).

Condition or disease
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.

Layout table for study information
Study Type : Observational
Actual Enrollment : 300 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Diagnostic and Prognostic Value of Serial PCT Measurements in Critically Ill Patients
Study Start Date : April 2011
Actual Primary Completion Date : November 2012
Actual Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis

Group/Cohort
Sepsis or Septic shock cohort
Non-sepsis or non-Septic shock cohort



Primary Outcome Measures :
  1. Development of organ failure [ Time Frame: Current hospitalization (participants will be followed for the duration of hospital stay; an expected average of 7-days) ]
  2. 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) ]
  3. ICU and Hospital Mortality [ Time Frame: current hospitalization or 28-day post ICU admission for ICU survivors ]

Secondary Outcome Measures :
  1. 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) ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
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.
Criteria

Inclusion Criteria:

  • All consecutive patients admitted to the Medical Intensive Care Unit of the Cleveland Clinic with an anticipated MICU stay of ≥ 12hrs

Exclusion Criteria:

  • Age less than 18-years of age and/or an expected MICU stay of less than 12-hrs

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01362920


Locations
Layout table for location information
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
BioMérieux
Investigators
Layout table for investigator information
Principal Investigator: Jorge A Guzman, MD The Cleveland Clinic
Layout table for additonal information
Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01362920    
Other Study ID Numbers: PCT-001
First Posted: June 1, 2011    Key Record Dates
Last Update Posted: February 18, 2013
Last Verified: February 2013
Keywords provided by The Cleveland Clinic:
Sepsis
Septic shock
Procalcitonin
PCT
Additional relevant MeSH terms:
Layout table for MeSH terms
Sepsis
Critical Illness
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Disease Attributes