NCT01841190

Brief Summary

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
128

participants targeted

Target at P50-P75 for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 24, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 26, 2013

Completed
Last Updated

April 26, 2013

Status Verified

March 1, 2013

Enrollment Period

8 months

First QC Date

April 24, 2013

Last Update Submit

April 25, 2013

Conditions

Severe SepsisSeptic Shock

Keywords

PrognosisSepsisSeptic shockProcalcitoninSOFA

Outcome Measures

Primary Outcomes (1)

  • MORTALITY

    28 DAYS

Study Arms (2)

PROCALCITONIN

DELTA SOFA

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Children
  • Pregnant.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospital Sao Domingos

São Luís, Maranhão, 65060-642, Brazil

RECRUITING

Hospital Sao Domingos

São Luís, Maranhão, 65060-642, Brazil

RECRUITING

Related Publications (1)

  • de Azevedo JR, Torres OJ, Beraldi RA, Ribas CA, Malafaia O. Prognostic evaluation of severe sepsis and septic shock: procalcitonin clearance vs Delta Sequential Organ Failure Assessment. J Crit Care. 2015 Feb;30(1):219.e9-12. doi: 10.1016/j.jcrc.2014.08.018. Epub 2014 Sep 10.

    PMID: 25241933DERIVED

MeSH Terms

Conditions

SepsisShock, Septic

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Central Study Contacts

JOSE R AZEVEDO, MD

CONTACT

55 98 32168110jrazevedo@elo.com.br

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD. COORDINATOR. ICU.

Study Record Dates

First Submitted

April 24, 2013

First Posted

April 26, 2013

Study Start

May 1, 2012

Primary Completion

January 1, 2013

Last Updated

April 26, 2013

Record last verified: 2013-03

Locations

BR(2)