Oxidative Stress in Critical Ill Patients in Surgical Int... | NCT00745888

Studies
Oxidative Stress in Critical Ill Patients in Surgical Intensive Care Unit

NCT00745888

Sponsor

National Taiwan University Hospital

Status

Unknown status

Last Update Posted

Sep 9, 2009Estimated

Enrollment

200Estimated

Phase

Not provided

Conditions

Sepsis
Shock

Interventions

Chemiluminescence Analyzer

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

Status Module

Record Verification Date

Aug 2009

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 2007

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Sep 2, 2008

First Submission Date that Met QC Criteria

Sep 2, 2008

First Posted Date

Sep 3, 2008Estimated

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

Sep 4, 2009

Last Update Posted Date

Sep 9, 2009Estimated

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

In clinical practice, the oxidative stress is related to circulatory shock, sepsis, acute lung injury, and acute respiratory distress syndrome. There are some questions on the oxidative stress of the critical illness. First, the investigators want to search out the effects of the past history, smoking, alcohol drinking, use of antioxidants, different diseases, and different duration of SIRS on the degree of oxidative stress. Second, besides total count of ROS, the investigators used new techniques to determine superoxide(O2●-), hydrogen peroxide (H2O2), and hypochlorous acid(HOCl). Furthermore, we want to investigate the correlation of the degree of different reactive oxygen species and the severity of SIRS or shock. Third, we try to investigate the correlation between the change of oxidative stress and the prognosis of the patients.

The investigators wish this study will help them to investigate the effect of oxidative stress on critical ill patients, to modulate the oxidative stress, to decrease the occurrence of SIRS, shock, and multiorgan failure, and to improve the long term outcome of patients.

Detailed Description

Not provided

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

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		age > 18 y/o Patients admitted to surgical ICU	Other: Chemiluminescence Analyzer

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Chemiluminescence Analyzer	Other	measure reactive oxygen species	1

Measure	Description	Time Frame
28-day Survival		28 days

Measure	Description	Time Frame
Days stay in ICU Days on ventilator SOFA score Complications		28 days

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age > 18 y/o
Admitted to surgical ICU

Exclusion Criteria:

Patients with brain death

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

Patients admitted to surgical ICU

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yu-Chang Yeh, MD	Contact	886-9-68661829		tonyyeh@ntuh.gov.tw

Overall Officials

Name	Affiliation	Role
Yu-Chang Yeh	National Taiwan University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Taiwan University Hospital	Recruiting	Taipei		100	Taiwan

Condition Browse Module

MeSH Terms

ID	Term
D018805	Sepsis
D012769	Shock

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

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