Prognostic Evaluation Of Severe Sepsis And Septic Shock. Procalcitonin Versus Delta Sofa

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by Hospital Sao Domingos
Sponsor:
Information provided by (Responsible Party):
José Raimundo Araujo de Azevedo, Hospital Sao Domingos
ClinicalTrials.gov Identifier:
NCT01841190
First received: April 24, 2013
Last updated: April 25, 2013
Last verified: March 2013
  Purpose

The purpose of this study is to compare the tendency of plasma concentration and clearance of procalcitonin in the first 24 and 48 hours of management of patients with severe sepsis and septic shock with another marker of early prognosis represented by 48 hours delta sofa.


Condition
Severe Sepsis
Septic Shock

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: PROGNOSTIC EVALUATION OF SEVERE SEPSIS AND SEPTIC SHOCK. PROCALCITONIN VERSUS DELTA SOFA

Resource links provided by NLM:


Further study details as provided by Hospital Sao Domingos:

Primary Outcome Measures:
  • MORTALITY [ Time Frame: 28 DAYS ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 128
Study Start Date: May 2012
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
PROCALCITONIN
DELTA SOFA

Detailed Description:

This is a cohort prospective observational study that will include adult patients admitted to a multidisciplinary ICU of a tertiary hospital.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Adult patients with severe sepsis and septic shock admitted to a multidisciplinary ICU

Criteria

Inclusion Criteria:

  • Adult patients admitted to the ICU
  • severe sepsis and septic shock

Exclusion Criteria:

  • Children
  • Pregnant.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01841190

Contacts
Contact: JOSE R AZEVEDO, MD 55 98 32168110 jrazevedo@elo.com.br

Locations
Brazil
Hospital Sao Domingos Recruiting
Sao Luis, Maranhao, Brazil, 65060-642
Contact: ORLANDO J TORRES, PhD    559832168100    o.torres@uol.com.br   
Hospital Sao Domingos Recruiting
Sao Luis, MA, Brazil, 65060-642
Contact: JOSE R AZEVEDO, MD    55 98 32168110    jrazevedo@elo.com.br   
Principal Investigator: JOSE R AZEVEDO, MD         
Sponsors and Collaborators
Hospital Sao Domingos
  More Information

No publications provided

Responsible Party: José Raimundo Araujo de Azevedo, MD. COORDINATOR. ICU., Hospital Sao Domingos
ClinicalTrials.gov Identifier: NCT01841190     History of Changes
Other Study ID Numbers: hsd1509
Study First Received: April 24, 2013
Last Updated: April 25, 2013
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Hospital Sao Domingos:
Prognosis
Sepsis
Septic shock
Procalcitonin
SOFA

Additional relevant MeSH terms:
Sepsis
Shock
Shock, Septic
Toxemia
Infection
Inflammation
Pathologic Processes
Systemic Inflammatory Response Syndrome

ClinicalTrials.gov processed this record on October 29, 2014