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NCT00745888 Clinical Trial

Oxidative Stress in Critical Ill Patients in Surgical Intensive Care Unit

Sepsis Clinical Trial

Official title:
Oxidative Stress in Critical Ill Patients in Surgical Intensive Care Unit

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00745888
Other study ID # 9561709132
Secondary ID
Status Recruiting
Phase Phase 3
First received September 2, 2008
Last updated September 4, 2009
Start date May 2007

Study information
Verified date August 2009
Source National Taiwan University Hospital
Contact Yu-Chang Yeh, MD
Phone 886-9-68661829
Email tonyyeh@ntuh.gov.tw
Is FDA regulated No
Health authority Taiwan: Department of Health
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 200
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Age > 18 y/o

- Admitted to surgical ICU

Exclusion Criteria:

- Patients with brain death

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Other:
• Chemiluminescence Analyzer
measure reactive oxygen species

Locations
Country Name City State
Taiwan National Taiwan University Hospital Taipei

Sponsors (1)
Lead Sponsor Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome
Type Measure Description Time frame Safety issue
Primary 28-day Survival 28 days No
Secondary Days stay in ICU Days on ventilator SOFA score Complications 28 days No
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