NCT03601767

Brief Summary

The aim of the present study is to develop a prognostic tool to assess the risk of dead and major complications in patient admitted to hospital for infection. A detailed database of clinical, biochemical and microbiological data is recorded and each item is analyzed and compared with clinical outcomes to develop a prognostic score.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2017

Geographic Reach
1 country

1 active site

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

September 20, 2017

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 30, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 26, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
Last Updated

July 26, 2018

Status Verified

July 1, 2018

Enrollment Period

1.3 years

First QC Date

May 30, 2018

Last Update Submit

July 25, 2018

Conditions

Sepsis

Keywords

sepsisscore

Outcome Measures

Primary Outcomes (1)

  • mortality

    at 28 days

Secondary Outcomes (1)

  • major complications

    at 28 days

Eligibility Criteria

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

subjects presenting to the accident and emergency department and admitted to hospital for any infection

You may qualify if:

  • al least 18 years old
  • admission to hospital for any infection for more than 72 hours

You may not qualify if:

  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ospedale San Paolo Polo Univesitario - ASST Santi Paolo e Carlo

Milan, 20142, Italy

RECRUITING

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Livio Colombo, MD

CONTACT

+390281844250livio.colombo@asst-santipaolocarlo.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant in Acute Medicine

Study Record Dates

First Submitted

May 30, 2018

First Posted

July 26, 2018

Study Start

September 20, 2017

Primary Completion

January 1, 2019

Study Completion

August 1, 2019

Last Updated

July 26, 2018

Record last verified: 2018-07

Locations

IT(1)