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

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

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.

Study Overview

• Status: Completed
• Conditions: Liver Failure; Sepsis; Renal Failure; ARDS; Brain Death
• Intervention / Treatment: Other: Critical care

• Study Type: Observational
• Enrollment (Actual): 124

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan
    • National Taiwan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Paitents admitted to intensive care unit with the following conditions Sepsis Postoperative care ARDS Renal Failure Liver failure Brain death

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

6

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
1; Patients with sepsis	Other: Critical care; Standard care for each group of patients
2; Patient admitted for postoperative care	Other: Critical care; Standard care for each group of patients
3; Patients with ARDS	Other: Critical care; Standard care for each group of patients
4; Patients with ARF	Other: Critical care; Standard care for each group of patients
5; Patients who receive liver support treatment	Other: Critical care; Standard care for each group of patients
6; Patients wiht brain death	Other: Critical care; Standard care for each group of patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mortality Severity of Organ Failure	28 days

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Principal Investigator: Yu-Chang Yeh, M.D, National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start: September 1, 2007
• Primary Completion (Actual): July 1, 2010
• Study Completion (Actual): July 1, 2011

Study Registration Dates

• First Submitted: December 15, 2008
• First Submitted That Met QC Criteria: December 15, 2008
• First Posted (Estimate): December 16, 2008

Study Record Updates

• Last Update Posted (Estimate): January 6, 2015
• Last Update Submitted That Met QC Criteria: January 5, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Hepatic Insufficiency; Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Liver Diseases; Death; Unconsciousness; Consciousness Disorders; Coma; Liver Failure; Brain Death
• Other Study ID Numbers: 200707012

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No