NCT01523717

Brief Summary

The purpose of this study is to investigate the relationship between a procalcitonin decrease over 72 hours and outcome in patients who have severe sepsis or septic shock.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
858

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2011

Typical duration for all trials

Geographic Reach
1 country

13 active sites

Status
completed

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

December 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 19, 2012

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 1, 2012

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

March 17, 2015

Status Verified

March 1, 2015

Enrollment Period

2.2 years

First QC Date

January 19, 2012

Last Update Submit

March 13, 2015

Conditions

Keywords

procalcitonindecrease over 72 hourssevere sepsisseptic shock

Outcome Measures

Primary Outcomes (1)

  • 28 day all cause mortality

    participants will be followed up for 28 days

    within 28 day safter inlclusion

Secondary Outcomes (1)

  • all-cause in-hospital mortality

    mortality during hospital stay

Eligibility Criteria

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

adult patients with severe sepsis or septic shock in the emergency department, medical floor, ICU

You may qualify if:

  • Adult patients (i.e. \>18 years of age) diagnosed with severe sepsis or septic shock as defined in Appendix 1, who are already in the ICU or come from the ED, other wards or directly from out of hospital
  • Blood sample collection within 12 hours after diagnosis "severe sepsis or septic shock"No prior enrollment into this study
  • Written informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

University of California Davis Health System

Sacramento, California, 95817, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Saint Vincent Hospital

Worcester, Massachusetts, 01608, United States

Location

Detroit Receiving Hospital

Detroit, Michigan, 48201, United States

Location

Sinai Grace Hospital

Detroit, Michigan, 48201, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

New York Methodist Hospital

New York, New York, 11215, United States

Location

Stony Brook University

New York, New York, 11794, United States

Location

Carolinas Medical Center

Charlotte, North Carolina, 28203, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

EDTA plasma and serum samples

MeSH Terms

Conditions

SepsisShock, Septic

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Study Officials

  • Nathan Shapiro, MD

    Beth Israel Deaconess Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 19, 2012

First Posted

February 1, 2012

Study Start

December 1, 2011

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

March 17, 2015

Record last verified: 2015-03

Locations