Prognostic Evaluation Of Severe Sepsis And Septic Shock.... | NCT01841190

Studies
Prognostic Evaluation Of Severe Sepsis And Septic Shock. Procalcitonin Versus Delta Sofa

NCT01841190

Sponsor

Hospital Sao Domingos

Status

Unknown status

Last Update Posted

Apr 26, 2013Estimated

Enrollment

128Estimated

Phase

Not provided

Conditions

Severe Sepsis
Septic Shock

Interventions

Not provided

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2012

Primary Completion Date

Jan 2013Actual

Completion Date

Not provided

First Submitted Date

Apr 24, 2013

First Submission Date that Met QC Criteria

Apr 25, 2013

First Posted Date

Apr 26, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 25, 2013

Last Update Posted Date

Apr 26, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

José Raimundo Araujo de Azevedo, MD. COORDINATOR. ICU., Hospital Sao DomingosPrincipal Investigator

Lead Sponsor

Hospital Sao DomingosOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

This is a cohort prospective observational study that will include adult patients admitted to a multidisciplinary ICU of a tertiary hospital.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

128Estimated

Measure	Description	Time Frame
MORTALITY		28 DAYS

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult patients admitted to the ICU
severe sepsis and septic shock

Exclusion Criteria:

Children
Pregnant.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
JOSE R AZEVEDO, MD	Contact	55 98 32168110		jrazevedo@elo.com.br

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Sao Domingos	Recruiting	São Luís	Maranhão	65060-642	Brazil

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25241933	Derived	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.

Label	Type	Description	Intervention Names
PROCALCITONIN
DELTA SOFA

ID	Term
D018805	Sepsis
D012772	Shock, Septic

ID	Term
D007239	Infections
D018746	Systemic Inflammatory Response Syndrome
D007249	Inflammation
D010335	Pathologic Processes