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

Sepsis Clinical Trial

— PCT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01362920
• Other study ID #: PCT-001
• Status: Completed
• Phase: N/A
• First received: April 6, 2011
• Last updated: February 15, 2013
• Start date: April 2011
• Est. completion date: November 2012

Study information

• Verified date: February 2013
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical 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). 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Critical Illness
• Sepsis

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
The Cleveland Clinic	BioMérieux

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Development of organ failure		Current hospitalization (participants will be followed for the duration of hospital stay; an expected average of 7-days)	No
Primary	Development and resolution of shock using a cut-off PCT of >0.5ng/mL		ICU stay (participants will be followed for the duration of hospital stay; an expected average of 7-days)	No
Primary	ICU and Hospital Mortality		current hospitalization or 28-day post ICU admission for ICU survivors	No
Secondary	Development of hospital acquired infections (catheter related blood stream infection, development of multidrug resistant infections, ventilator associated pneumonia)		Current hospitalization (participants will be followed for the duration of hospital stay; an expected average of 7-days)	No