Microcirculation and Oxidative Stress in Critical Ill Patients in Surgical Intensive Care Unit

Sepsis Clinical Trial

Official title:

Microcirculation and Oxidative Stress in Critically Ill Patients in Surgical Intensive Care Unit

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00808691
• Other study ID #: 200707012
• Status: Completed
• Phase: N/A
• First received: December 15, 2008
• Last updated: January 5, 2015
• Start date: September 2007
• Est. completion date: July 2011

Study information

• Verified date: January 2015
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Observational

Clinical Trial Summary

As medicine advances, many lives can be saved in the intensive care unit. However, when multiple organ failure occurs, the mortality rate of patients increases dramatically. Therefore, the major goal in the intensive care unit is to prevent the occurrence of multiple organ failure. The sepsis protocol and early goal directed treatment have great effects to reduce development of multiple organ failure and to decrease the mortality rate. However, sometime the condition of patient deteriorated in spite of both the mean blood pressure and mixed venous oxygen saturation are normal. Some experts recognize that there might be microcirculatory dysfunction of tissue or organ. The dysfunction of microcirculation might due to vasoconstriction or microthrombosis. Vasoconstriction might result from systemic inflammation, reactive oxygen species, or dysfunction of synthesis of NO (nitric oxide). Microthrombosis might result from systemic inflammation, reactive oxygen species, imbalance of coagulatory system, or damage of endothelial cell.

In clinical practice, the oxidative stress is related to circulatory shock, sepsis, acute lung injury, and acute respiratory distress syndrome. This study tries to investigate the relation between oxidative stress and microcirculation. Furthermore, the investigators will try to investigate the correlation between the severity of oxidative stress and microcirculatory dysfunction and the severity of disease and prognosis. The investigators hope this study will help them to figure out the picture of disease progression of patients. It may conduct further study to modulate the oxidative stress, to improve the microcirculatory function, and finally to improve the outcome of patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: July 2011
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• > 18 y/o

• Related diagnosis made within 24h

• Group 1 - Sepsis

• Group 2 - Postoperative care

• Group 3 - ARDS

• Group 4 - Renal failure

• Group 5 - Liver failure

• Group 6 - Brain death

Exclusion Criteria:

• Pregnant patients

• Related diagnosis made longer than 24h

• Patients who have received antioxidants within 24h

• Patients who have received hyperbaric oxygen therapy

• Patients who have a hemoglobin value less than 9 g/dl

• Patients who have received NO

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• ARDS
• Brain Death
• Liver Failure
• Renal Failure
• Sepsis

Intervention

Other:
• Critical care
Standard care for each group of patients

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	Mortality Severity of Organ Failure		28 days	No