SepsisNCT00808691
Microcirculation and Oxidative Stress in Critical Ill Patients in Surgical Intensive Care Unit
An observational study of Sepsis and ARDS, run by National Taiwan University Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, ARDS, Liver Failure
- What is being tested?
- Critical care
- How many people
- 124 participants
- Where
- 1 siteTaiwan
- Study dates
- Sep 2007to Jul 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Paitents admitted to intensive care unit with the following conditions Sepsis Postoperative care ARDS Renal Failure Liver failure Brain death
Who may be able to join
- > 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Sepsis, ARDS, Liver Failure, Renal Failure, Brain Death
- Being tested
- Critical care
- Medical subject headings
- Sepsis, Liver Failure, Renal Insufficiency, Brain Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Critical careOther
Standard care for each group of patients
| Study group | Role | What they receive |
|---|---|---|
| 1 | Patients with sepsis Receives: Other: Critical care | |
| 2 | Patient admitted for postoperative care Receives: Other: Critical care | |
| 3 | Patients with ARDS Receives: Other: Critical care | |
| 4 | Patients with ARF Receives: Other: Critical care | |
| 5 | Patients who receive liver support treatment Receives: Other: Critical care | |
| 6 | Patients wiht brain death Receives: Other: Critical care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality Severity of Organ Failure
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2008 (estimated)
- Study startSep 2007
- Primary completionJul 2010
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yu-Chang Yeh, M.D, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00808691
- Sponsor's protocol ID
- 200707012
- Status last verified
- Jan 2015
- First submitted
- 15 Dec 2008
- Last updated
- 6 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microcirculation and Oxidative Stress in Critically Ill Patients in Surgical Intensive Care Unit
- ClinicalTrials.gov ID
- NCT00808691
- Acronym / sponsor ID
- 200707012
- Conditions
- Sepsis, ARDS, Liver Failure, Renal Failure, Brain Death
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 16 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Other: Critical carePatients with sepsis |
| 2 | – | Other: Critical carePatient admitted for postoperative care |
| 3 | – | Other: Critical carePatients with ARDS |
| 4 | – | Other: Critical carePatients with ARF |
| 5 | – | Other: Critical carePatients who receive liver support treatment |
| 6 | – | Other: Critical carePatients wiht brain death |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Paitents admitted to intensive care unit with the following conditions Sepsis Postoperative care ARDS Renal Failure Liver failure Brain death
Key inclusion criteria (8 listed)
- > 18 y/o
- Related diagnosis made within 24h
- Group 1 - Sepsis
- Group 2 - Postoperative care
- Group 3 - ARDS
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Critical careStandard care for each group of patients | Other | 1, 2, 3, 4, 5, 6 |
Primary outcome
Mortality Severity of Organ Failure
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2015.
Related trials for Sepsis
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Ventilator-Induced Lung Injury, Sepsis Syndrome
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A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
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Not yet recruiting
Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
Acute-on-Chronic Liver Failure (ACLF)
Active, not recruitingPhase 4
Thymosin Alpha 1 and IgM Levels in Sepsis
Sepsis, Septic Shock
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yu-Chang Yeh, M.D principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis and ARDS, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality Severity of Organ Failure (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2015.