Sepsis Institutional Registry (SIR)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Diego Hernan Giunta, MD, Hospital Italiano de Buenos Aires
ClinicalTrials.gov Identifier:
NCT01403935
First received: July 26, 2011
Last updated: March 20, 2014
Last verified: March 2014
  Purpose

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.


Condition
Death
Severe Sepsis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Sepsis Institutional Registry in Hospital Italiano de Buenos Aires

Resource links provided by NLM:


Further study details as provided by Hospital Italiano de Buenos Aires:

Primary Outcome Measures:
  • clinical features, mortality [ Time Frame: Clinical characteristics are evaluated during the acute event and in-hospital mortality and annual monitoring ] [ Designated as safety issue: No ]

Enrollment: 7472
Study Start Date: December 2007
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Detailed Description:

The main goal is to describe the occurrence of sepsis and the characteristics of clinical presentation, evolution and predisposing factors within the population of the Hospital Italiano de Buenos Aires.

  Eligibility

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

Adults with sepsis

Criteria

Inclusion Criteria:

  1. Over 17 years
  2. Two or more sirs criteria
  3. Active infection

Exclusion Criteria:

  1. Refusal to register or to the informed consent process
  2. Ambulatory patients
  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: NCT01403935

Locations
Argentina
Hospital Italiano de Buenos Aires, Gascon 450
Buenos Aires, Argentina
Sponsors and Collaborators
Hospital Italiano de Buenos Aires
  More Information

No publications provided

Responsible Party: Diego Hernan Giunta, MD, MD, Hospital Italiano de Buenos Aires
ClinicalTrials.gov Identifier: NCT01403935     History of Changes
Other Study ID Numbers: 1172
Study First Received: July 26, 2011
Last Updated: March 20, 2014
Health Authority: Argentina: Human Research Bioethics Committee

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

ClinicalTrials.gov processed this record on July 24, 2014