NCT01403935

Brief Summary

The purpose of this study is to create an institutional registry of sepsis through a prospective survey based on epidemiological data, risk factors, diagnosis, prognosis, treatment, monitoring and survival.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
7,472

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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, 2007

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

July 26, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 27, 2011

Completed
2.6 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

August 13, 2019

Status Verified

August 1, 2019

Enrollment Period

6.3 years

First QC Date

July 26, 2011

Last Update Submit

August 9, 2019

Conditions

DeathSevere Sepsis

Outcome Measures

Primary Outcomes (1)

  • clinical features, mortality

    Clinical characteristics are evaluated during the acute event and in-hospital mortality and annual monitoring

Eligibility Criteria

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

Adults with sepsis

You may qualify if:

  • Over 17 years
  • Two or more sirs criteria
  • Active infection

You may not qualify if:

  • Refusal to register or to the informed consent process
  • Ambulatory patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Italiano de Buenos Aires, Gascon 450

Buenos Aires, Argentina

Location

MeSH Terms

Conditions

DeathSepsis

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsInfectionsSystemic Inflammatory Response SyndromeInflammation

Study Officials

  • Diego H Giunta, MD

    Hospital Italiano de Buenos Aires

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

July 26, 2011

First Posted

July 27, 2011

Study Start

December 1, 2007

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

August 13, 2019

Record last verified: 2019-08

Locations

AR(1)