Body WeightNCT01351506
Effect of Body Weight Change to Surgical ICU Outcomes
An observational study of Body Weight and Weight Change, run by Chiang Mai University at 1 site in Thailand.
Trial summary
Aims of study 1. Effect of daily weight change upto 7 days from ICU admission to outcome of treatment in 28 days 2. Determination cut point of maximum weight change to outcome treatment Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Body Weight, Weight Change
- How many people
- 465 participants
- Where
- 1 siteThailand
- Study dates
- May 2011to Aug 2012
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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: All admitted ICU patients which expected survive more than 24 hours.
Who may be able to join
- All admitted ICU patients expected survive more than 24 hours
Who cannot join
- All expected ICU patients survive less than 24 hours
- All patient cannot be weighed.
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Department of Surgery, Faculty of Medicine, Maharaj Nakorn Chiang Mai hospital
Muang Chiang Mai, Chiang Mai, 50200
About this study
Official title: Effect and Determinant Level of Admission Body Weight and Daily Weight Change and Prognoses of Critically and High Risk Surgical Patients
Aims of study
- Effect of daily weight change upto 7 days from ICU admission to outcome of treatment in 28 days
- Determination cut point of maximum weight change to outcome treatment
Read the detailed description
Study type : Prospective observational study Location : General surgical intensive care unit Inclusion criteria : All admission patient with expected survive more than 24 hours Exclusion criteria : Patient died within 24 hours or who could not be weighed.
- Conditions
- Body Weight, Weight Change
- Keywords
- Body weight, Body mass index, Weight change, ICU outcomes
- Medical subject headings
- Body Weight, Body Weight Changes
What is being measured
The primary outcome is the main question the study is designed to answer.
In Hospital Mortality
28 days mortality if patient still have be admitted in hospital.
Measured: within 28 days after ICU admission to dead
Secondary outcomes (2)
Re Intubation Within 72 Hours
Patient who need re-intubation within 72 hours
Measured: ICU complications up to 28 days after ICU admission
Acute Kidney Injury
New acute kidney injury in ICU
Measured: Acute kidney injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2011 (estimated)
- Study startMay 2011
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Body WeightStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 465 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chiang Mai University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kaweesak Chittawatanarat, Chiang Mai University
- Investigators
- Kaweesak Chittawatanarat Assistant Professor, Principal investigator, Chaing Mai University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01351506
- Sponsor's protocol ID
- 10FEB010924
- Status last verified
- Nov 2014
- First submitted
- 9 May 2011
- Last updated
- 7 Nov 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Chittawatanarat K, Pichaiya T, Chandacham K, Jirapongchareonlap T, Chotirosniramit N. Fluid accumulation threshold measured by acute body weight change after admission in general surgical intensive care units: how much should be concerning? Ther Clin Risk Manag. 2015 Jul 27;11:1097-106. doi: 10.2147/TCRM.S86409. eCollection 2015.
PubMed 26251605
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect and Determinant Level of Admission Body Weight and Daily Weight Change and Prognoses of Critically and High Risk Surgical Patients
- ClinicalTrials.gov ID
- NCT01351506
- Acronym / sponsor ID
- 10FEB010924
- Conditions
- Body Weight, Weight Change
- Keywords
- Body weight, Body mass index, Weight change, ICU outcomes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 465 participants (actual)
- Lead sponsor
- Chiang Mai UniversityUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 11 May 2011 (estimated)
- Results
- Posted 7 Nov 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Aims of study
- Effect of daily weight change upto 7 days from ICU admission to outcome of treatment in 28 days
- Determination cut point of maximum weight change to outcome treatment
Detailed description
Study type : Prospective observational study Location : General surgical intensive care unit Inclusion criteria : All admission patient with expected survive more than 24 hours Exclusion criteria : Patient died within 24 hours or who could not be weighed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All admitted ICU patients which expected survive more than 24 hours.
Key inclusion criteria (1 listed)
- All admitted ICU patients expected survive more than 24 hours
Key exclusion criteria (2 listed)
- All expected ICU patients survive less than 24 hours
- All patient cannot be weighed.
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
In Hospital Mortality
Time frame: within 28 days after ICU admission to dead
28 days mortality if patient still have be admitted in hospital.
2 secondary outcomes
Re Intubation Within 72 Hours
Time frame: ICU complications up to 28 days after ICU admission
Acute Kidney Injury
Time frame: Acute kidney injury
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26251605Chittawatanarat K, Pichaiya T, Chandacham K, Jirapongchareonlap T, Chotirosniramit N. Fluid accumulation threshold measured by acute body weight change after admission in general surgical intensive care units: how much should be concerning? Ther Clin Risk Manag. 2015 Jul 27;11:1097-106. doi: 10.2147/TCRM.S86409. eCollection 2015.
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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.
Kaweesak Chittawatanarat Assistant Professor principal investigator
Chaing Mai University
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 Body Weight and Weight Change, run by Chiang Mai University at 1 site in Thailand.
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 1 inclusion and 2 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 7 Nov 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 Thailand. 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?
Yes. Results are posted in the registry (first posted 7 Nov 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
In Hospital Mortality (time frame: within 28 days after ICU admission to dead). 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 NCT01351506, 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 7 Nov 2014.