Outcome Predictors in Patients With Severe Sepsis and Opt... | NCT01362829

Studies
Outcome Predictors in Patients With Severe Sepsis and Optimized Central Venous Oxygen Saturation

NCT01362829

Sponsor

National Taiwan University Hospital

Status

Completed

Last Update Posted

Jun 21, 2011Estimated

Enrollment

90Actual

Phase

Not provided

Conditions

Sepsis

Interventions

Determined by intended physician

Countries

Taiwan

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

ID	Type	Description	Link
098014-3	Other Identifier	Far Eastern Memorial Hospital

Status Module

Record Verification Date

May 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2009

Primary Completion Date

May 2011Actual

Completion Date

May 2011Actual

First Submitted Date

May 24, 2011

First Submission Date that Met QC Criteria

May 27, 2011

First Posted Date

May 30, 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

Jun 20, 2011

Last Update Posted Date

Jun 21, 2011Estimated

Name	Class
Far Eastern Memorial Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

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 investigators perform a prospective observation study to search for the outcome predictors (ScvO2 and lactate) in patients with severe sepsis after admission to ICU.

Detailed Description

Early goal-directed therapy in patients with severe sepsis or septic shock was found to provide survival benefit.It was thought that early optimization of ScvO2 within 6 hours in emergency department brought survival benefit to patients of septic shock or severe sepsis.On the other hand, early lactate clearance is associated with improved outcome in patients with severe sepsis or septic shock. In patients with severe sepsis and septic shock, those with low lactate clearance had poor prognosis, despite optimization of ScvO2. It is unknown if ScvO2 could still guide hemodynamic resuscitation after admission into ICU. The investigators perform a prospective observation study to see the correlation between ScvO2 and clinical outcome (including organ failure, disease severity, and survival) and the correlation between lactate and clinical outcome. Furthermore, if ScvO2 >= 70% is still of prognostic significance in ICU, we will investigate the outcome in patients with high ScvO2 and high serum lactate levels, and to evaluate the clinical features of this patient population.

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

Retention

Enrollment

90Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients with severe sepsis		Patients who are admitted to medical ICU with severe sepsis	Other: Determined by intended physician

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Determined by intended physician	Other	We perform a prospective observational study. All the treatment for the patients are determined by intended physicians.	Patients with severe sepsis

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
28-day Mortality	Record 28-day all-cause mortality in each population (low ScvO2, high ScvO2 and low serum lactate, high ScvO2 and high serum lactate)	28 days

Secondary Outcomes

Measure	Description	Time Frame
In-Hospital Mortality	Participants will be followed for the duration of hospital stay, an expected average of 2 months	2 months
Severity of organ failure	To evaluate the development of ARDS/ALI, AKI, and the record the SOFA score

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult patients who are admitted to medical intensive care units with severe sepsis or septic shock

Exclusion Criteria:

Patients would be excluded if they have any one of the exclusion criteria, *including pregnancy
- presence of acute cerebral vascular attack
- acute cardiogenic lung edema
- status asthmatics
- cardiac dysrhythmia as the primary diagnosis
- massive gastrointestinal bleeding
- epileptics
- drug overdose
- requirement of immediate surgery
- hematologic malignancies
- febrile neutropenia
- treatment with immunosuppressive agents before admission
- advanced malignancy and poor pre-admission performance status
- with inevitable short-term mortality or morbidity
- HIV infection
- refusal of consent

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 who are admitted to medical intensive care units due to severe sepsis or septic shock

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Chong-Jen Yu, MD, PhD	National Taiwan University Hospital	Principal Investigator
Hou-Tai Chang, MD	Far Eastern Memorial Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Far Eastern Memorial Hospital		Taipei		100	Taiwan
National Taiwan University Hospital

Condition Browse Module

MeSH Terms

ID	Term
D018805	Sepsis

Ancestor Terms

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

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Browse Branches

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