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

NCT01362920 | Completed

• 1 other identifier: PCT-001
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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).

Conditions

Sepsis

Keywords

Sepsis; Septic shock; Procalcitonin; PCT

Outcome Measures

Primary Outcomes (3)

• Development of organ failure

  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

  ICU stay (participants will be followed for the duration of hospital stay; an expected average of 7-days)

• ICU and Hospital Mortality

  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)

  Current hospitalization (participants will be followed for the duration of hospital stay; an expected average of 7-days)

Study Arms (2)

Sepsis or Septic shock cohort

Non-sepsis or non-Septic shock cohort

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• The Cleveland Clinic: lead
• BioMérieux: collaborator

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Sepsis; Shock, Septic

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Officials

• Jorge A Guzman, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2011
• First Posted: June 1, 2011
• Study Start: April 1, 2011
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: February 18, 2013

Record last verified: 2013-02

Locations

US (1)