NCT00808691

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
124

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

December 15, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 16, 2008

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

January 6, 2015

Status Verified

January 1, 2015

Enrollment Period

2.8 years

First QC Date

December 15, 2008

Last Update Submit

January 5, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • Mortality Severity of Organ Failure

    28 days

Study Arms (6)

1

Patients with sepsis

Other: Critical care

2

Patient admitted for postoperative care

Other: Critical care

3

Patients with ARDS

Other: Critical care

4

Patients with ARF

Other: Critical care

5

Patients who receive liver support treatment

Other: Critical care

6

Patients wiht brain death

Other: Critical care

Interventions

Standard care for each group of patients

123456

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • \> 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

SepsisLiver FailureRenal InsufficiencyBrain Death

Interventions

Critical Care

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsHepatic InsufficiencyLiver DiseasesDigestive System DiseasesKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesComaUnconsciousnessConsciousness DisordersNeurobehavioral ManifestationsNeurologic ManifestationsDeath

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Yu-Chang Yeh, M.D

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 15, 2008

First Posted

December 16, 2008

Study Start

September 1, 2007

Primary Completion

July 1, 2010

Study Completion

July 1, 2011

Last Updated

January 6, 2015

Record last verified: 2015-01

Locations