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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by National Taiwan University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00808691
First received: December 15, 2008
Last updated: June 28, 2010
Last verified: June 2010
  Purpose

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.


Condition Intervention
Sepsis
Postoperative Care
ARDS
Liver Failure
Renal Failure
Brain Death
Other: Critical care

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • Mortality Severity of Organ Failure [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 280
Study Start Date: September 2007
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00808691

Contacts
Contact: Yu-Chang Yeh, MD 886-9-68661829 tonyyeh@ntuh.gov.tw

Locations
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan
Contact: Yu-Chang Yeh, MD    886-9-68661829    tonyyeh@ntuh.gov.tw   
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Yu-Chang Yeh, M.D National Taiwan University Hospital
  More Information

No publications provided

Responsible Party: Yu-Chang Yeh/Doctor, National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT00808691     History of Changes
Other Study ID Numbers: 200707012
Study First Received: December 15, 2008
Last Updated: June 28, 2010
Health Authority: Taiwan: Department of Health

Additional relevant MeSH terms:
Coma
Brain Death
Liver Failure
Renal Insufficiency
Brain Diseases
Central Nervous System Diseases
Consciousness Disorders
Death
Digestive System Diseases
Hepatic Insufficiency
Kidney Diseases
Liver Diseases
Nervous System Diseases
Neurobehavioral Manifestations
Neurologic Manifestations
Pathologic Processes
Unconsciousness
Urologic Diseases

ClinicalTrials.gov processed this record on November 25, 2014