Multiple Organ Dysfunction SyndromeNCT01802983
The Prognostic Assessment of Extubation in Aged Patients With Multiple Organ Dysfunction Syndrome
An observational study of Multiple Organ Dysfunction Syndrome, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
The multiple organ dysfunction syndrome (MODS) has remained the major factor contributing to prolongation of intensive and mortality. It is reported that the mortality rates have varied between 20% and 100%, depending on number, severity, duration, type and combination, and definition of dysfunction. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Multiple Organ Dysfunction Syndrome
- How many people
- 1 participants
- Where
- 1 siteChina
- Study dates
- Jan 2009to Dec 2013
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All subjects were selected from among inpatients who were hospitalized between Jan 2009 and May 2013 in the Respiratory Intensive Care Unit(RICU),Surgical Intensive Care Unit(SICU) and Emergency Intensive Care Unit(EICU).
Who may be able to join
- age > 60 years old;
- presence of altered organ function in an acutely ill patient such that homeostasis cannot be maintained without intervention;
- have trachea intubation after admitting to intensive care unit within 24 hours.
Who cannot join
- end stage multiple organ failure.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853
Xie Lixin, doctor, +86 010 55499130, xielx@263.net
About this study
Official title: Key Technology Research of the Comprehensive Treatment of Multiple Organ Dysfunction Syndrome
The multiple organ dysfunction syndrome (MODS) has remained the major factor contributing to prolongation of intensive and mortality. It is reported that the mortality rates have varied between 20% and 100%, depending on number, severity, duration, type and combination, and definition of dysfunction. In our study, the investigators explore some comprehensive treatment technology to improved outcomes of MODS patients.
- Conditions
- Multiple Organ Dysfunction Syndrome
- Keywords
- Aged, Multiple organ failure, Extubation, Prognosis, MODS, invasive mechanical ventilation
- Medical subject headings
- Multiple Organ Failure
What is being measured
The primary outcome is the main question the study is designed to answer.
the prognostic assessment of aged patients with MODS
According to the outcomes of 28-day,all the enrolled patients were divided into survival group and death group, clinical datum of which were collected and analysed. And then these prognosis were evaluated with the current scoring systems [(Acute Physiology and Chronic Health EvaluationⅡ(APACHEⅡ, APACHE Ⅲ), Sample Acute Physiological score(SAPSⅡ), Multiple Organ Dysfunction score(MODS)], the predictive power of which were compared by receiver operating characteristic(ROC) curve. Finally, a binary logistic regression analysis was performed to evaluate the concerning prognostic factors of MODSE.
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 posted4 Mar 2013 (estimated)
- Study startJan 2009
- Primary completionDec 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple Organ Dysfunction SyndromeStudies of the same condition, open and under way.
- More trials run by Chinese PLA General 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 1 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kun Xiao, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01802983
- Sponsor's protocol ID
- 2013670808
- Status last verified
- Feb 2013
- First submitted
- 27 Feb 2013
- Last updated
- 4 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Xiao K, Su L, Han B, Guo C, Feng L, Jiang Z, Wang H, Lin Y, Jia Y, She D, Xie L. Prognosis and weaning of elderly multiple organ dysfunction syndrome patients with invasive mechanical ventilation. Chin Med J (Engl). 2014;127(1):11-7.
PubMed 24384417
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Key Technology Research of the Comprehensive Treatment of Multiple Organ Dysfunction Syndrome
- ClinicalTrials.gov ID
- NCT01802983
- Acronym / sponsor ID
- 2013670808
- Conditions
- Multiple Organ Dysfunction Syndrome
- Keywords
- Aged, Multiple organ failure, Extubation, Prognosis, MODS, invasive mechanical ventilation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 4 Mar 2013 (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.
The multiple organ dysfunction syndrome (MODS) has remained the major factor contributing to prolongation of intensive and mortality. It is reported that the mortality rates have varied between 20% and 100%, depending on number, severity, duration, type and combination, and definition of dysfunction. In our study, the investigators explore some comprehensive treatment technology to improved outcomes of MODS patients.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All subjects were selected from among inpatients who were hospitalized between Jan 2009 and May 2013 in the Respiratory Intensive Care Unit(RICU),Surgical Intensive Care Unit(SICU) and Emergency Intensive Care Unit(EICU).
Key inclusion criteria (3 listed)
- age > 60 years old;
- presence of altered organ function in an acutely ill patient such that homeostasis cannot be maintained without intervention;
- have trachea intubation after admitting to intensive care unit within 24 hours.
Key exclusion criteria (1 listed)
- end stage multiple organ failure.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
the prognostic assessment of aged patients with MODS
Time frame: 28 days
According to the outcomes of 28-day,all the enrolled patients were divided into survival group and death group, clinical datum of which were collected and analysed. And then these prognosis were evaluated with the current scoring systems [(Acute Physiology and Chronic Health EvaluationⅡ(APACHEⅡ, APACHE Ⅲ), Sample Acute Physiological score(SAPSⅡ), Multiple Organ Dysfunction score(MODS)], the predictive power of which were compared by receiver operating characteristic(ROC) curve. Finally, a binary logistic regression analysis was performed to evaluate the concerning prognostic factors of MODSE.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2013.
- Derived from this study: PubMed 24384417Xiao K, Su L, Han B, Guo C, Feng L, Jiang Z, Wang H, Lin Y, Jia Y, She D, Xie L. Prognosis and weaning of elderly multiple organ dysfunction syndrome patients with invasive mechanical ventilation. Chin Med J (Engl). 2014;127(1):11-7.
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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.
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 Multiple Organ Dysfunction Syndrome, run by Chinese PLA General Hospital at 1 site in China.
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 3 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 4 Mar 2013. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiao Kun, doctor (+8613716608331, xiaok301@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the prognostic assessment of aged patients with MODS (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01802983, which also lists 1 linked publication.
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 4 Mar 2013.