SIRSNCT02002676
Prevalence and Outcome of Hypermetabolism in Initial Prevalence and Outcome of Hypermetabolism in Initial Phase of Intensive Care Unit Patient: a Prospective Observational Study
An observational study of SIRS and Sepsis, run by Nanjing University School of Medicine at 1 site in China.
Trial summary
Patients in critical illness frequently present hypermetabolism， which can extremely increase the rest energy expenditure（REE）. We hypothesize that if we alleviate the extremely increased REE will improve ICU patients' outcome Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SIRS, Sepsis, Septic Shock
- How many people
- 62 participants
- Where
- 1 siteChina
- Study dates
- Dec 2013to Jun 2014
- 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: Patients who admitted ICU with hypermatebolic status, which the results of indirect calorimetry show that the actual rest energy expenditure values are remarkably higher than the predicted ones.
Who may be able to join
- Older than 18 year.
- APACHEⅡ score≥8
Who cannot join
- Hypercortisolism
- Thyroid disease
- Tracheoesophageal fistula
- FiO2>60 or PEEP>12cm H2O in mechanical ventilate
- Pregnancy
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Nanjing University School of Medicine
Nanjing, Jiangsu, 210093
Chao Wu, Ph.D., 008615005171483, wuchao0008@126.com
About this study
Official title: Prevalence and Outcome of Hypermetabolism in Initial Phase of Intensive Care Unit Patient: a Prospective Observational Study
Patients in critical illness frequently present hypermetabolism， which can extremely increase the rest energy expenditure（REE）. We hypothesize that if we alleviate the extremely increased REE will improve ICU patients' outcome
Read the detailed description
This study focuses on the early changes of REE of critical ill patients when they admitted to ICU.
- Conditions
- SIRS, Sepsis, Septic Shock
- Keywords
- rest energy expenditure,critical ill, outcome
- Medical subject headings
- Sepsis, Shock, Septic
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality rate of 28 days
Measured: From ICU admission to 28th days of observation
Secondary outcomes (1)
Incidence of Multiple Organ Dysfunction Syndrome（MODS）in 60 days
Measured: From ICU admission to 60th days of observation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2013 (estimated)
- Study startDec 2013
- Primary completionJun 2014 (estimated)
- Study completionJun 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SIRSStudies of the same condition, open and under way.
- 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 only
- Time perspective
- Prospective
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanjing University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Jinling Hospital, China
- Responsible party
- Principal investigator, Chao Wu, Nanjing University School of Medicine
- Investigators
- Xinying Wang, MD, Study director, Nanjing University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02002676
- Sponsor's protocol ID
- 2013KLY-022
- Status last verified
- Jun 2014
- First submitted
- 26 Nov 2013
- Last updated
- 13 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Outcome of Hypermetabolism in Initial Phase of Intensive Care Unit Patient: a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT02002676
- Acronym / sponsor ID
- 2013KLY-022
- Conditions
- SIRS, Sepsis, Septic Shock
- Keywords
- rest energy expenditure,critical ill, outcome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Nanjing University School of MedicineUniversity, hospital or other
- Collaborators
- Jinling Hospital, China
- Study start
- Dec 2013
- Primary completion
- Jun 2014 (estimated)
- Study completion
- Jun 2014 (estimated)
- First posted
- 6 Dec 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.
Patients in critical illness frequently present hypermetabolism， which can extremely increase the rest energy expenditure（REE）. We hypothesize that if we alleviate the extremely increased REE will improve ICU patients' outcome
Detailed description
This study focuses on the early changes of REE of critical ill patients when they admitted to ICU.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who admitted ICU with hypermatebolic status, which the results of indirect calorimetry show that the actual rest energy expenditure values are remarkably higher than the predicted ones.
Key inclusion criteria (2 listed)
- Older than 18 year.
- APACHEⅡ score≥8
Key exclusion criteria (5 listed)
- Hypercortisolism
- Thyroid disease
- Tracheoesophageal fistula
- FiO2>60 or PEEP>12cm H2O in mechanical ventilate
- Pregnancy
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
Mortality rate of 28 days
Time frame: From ICU admission to 28th days of observation
1 secondary outcome
Incidence of Multiple Organ Dysfunction Syndrome（MODS）in 60 days
Time frame: From ICU admission to 60th days of observation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2014.
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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.
Xinying Wang, MD study director
Nanjing University School of Medicine
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 SIRS and Sepsis, run by Nanjing University School of Medicine 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 2 inclusion and 5 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 13 Jun 2014. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality rate of 28 days (time frame: From ICU admission to 28th days of observation). 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 13 Jun 2014.