Relationship Between Tissue Markes in Patients With Post... | NCT01455662

Studies
Relationship Between Tissue Markes in Patients With Post Cardio Respiratory Syndrome

NCT01455662

Sponsor

Hospital Nossa Senhora da Conceicao

Status

Unknown status

Last Update Posted

Nov 3, 2011Estimated

Enrollment

100Estimated

Phase

Not provided

Conditions

Cardiac Arrest

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

Nov 2011

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

Jan 2010

Primary Completion Date

Dec 2011Estimated

Completion Date

Dec 2011Estimated

First Submitted Date

Sep 28, 2011

First Submission Date that Met QC Criteria

Oct 19, 2011

First Posted Date

Oct 20, 2011Estimated

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

Nov 2, 2011

Last Update Posted Date

Nov 3, 2011Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Vanessa Martins de oliveira, Principal Investigator, Hospital Nossa Senhora da ConceicaoPrincipal Investigator

Lead Sponsor

Hospital Nossa Senhora da ConceicaoOTHER

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

There is a correlation between hospital mortality and changes in markers of tissue perfusion, lactate, and venous oxygen saturation and carbon dioxide gradient.

Detailed Description

Evaluation of the serum carbon dioxide gradient (GapCO2), central venous saturation (ScvO2) and the clearance of serum lactate (Clac) in predicting hospital mortality after cardiac arrest syndrome (post-PCR).

Prospective study, unicenter - Intensive Care Unit - HNSC. Period: May/2010 to June/2011. Serial assessment of GapCO2 of ScvO2 Clac and the first 72 hours post-PCR. Excluded under 18, survival of less than 6HS, pregnant women, traumatized, post-operative hypothermia and liver disease. T-student test, 95% (p <0.05).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

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

100Estimated

Label	Type	Description	Intervention Names
all patients after cardiac arrest

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
mortality		1 year

Secondary Outcomes

Measure	Description	Time Frame
correlation of clearance markers of perfusion with the use of vasopressor and positive fluid balance		6 hours

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All patients hospitalized in the intensive care unit after cardiopulmonary arrest with any pace

Exclusion Criteria:

pregnant women, traumatized, post-operative(less 7 days), hypothermia and liver disease.

patients hospitalized in the intensive care unit with more than 6 hours post cardiac arrest
less 18 years old

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

patients hospitalized in the intensive care unit after cardiopulmonary arrest

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Vanessa M Oliveira, MD	Contact	05192513723		vanessa.oliveira480@gmail.com
Diego Riveiro, MD	Contact	05184175632		dmriveiro@yahoo.com.br

Overall Officials

Name	Affiliation	Role
Vanessa Oliveira, MD	Conceição Hospital	Principal Investigator
Diego F Riveiro, MD	Hospital Nossa Senhora da Conceição	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Conceição Hospital	Recruiting	Porto Alegre	Rio Grande do Sul		Brazil

Condition Browse Module

MeSH Terms

ID	Term
D006323	Heart Arrest

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided