CClinicalTrials.gg
CompletedNCT01351506Updated Nov 7, 2014Results posted

Effect of Body Weight Change to Surgical ICU Outcomes

An observational study in Body Weight and Weight Change, sponsored by Chiang Mai University. Completed at 1 site in Thailand. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-11-07.

Sponsored by Chiang Mai University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
465
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Body Weight
  • Weight Change

Keywords

  • Body weight
  • Body mass index
  • Weight change
  • ICU outcomes
03

In context

Body Weight

1,224 studies on the registry are indexed under Body Weight; 132 are open to participants now.

This study's enrollment of 465 is above the median of 140 across 238 observational studies indexed under Body Weight.

Browse Body Weight studies →

Lead sponsor

Chiang Mai University is the lead sponsor of 116 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

All admitted ICU patients which expected survive more than 24 hours.

Inclusion criteria

  • All admitted ICU patients expected survive more than 24 hours

Exclusion criteria

Exclusion Criteria:

  • All expected ICU patients survive less than 24 hours
  • All patient cannot be weighed.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
465 participants (actual)
06

What researchers measure

Primary outcomes

  1. In Hospital Mortality

    28 days mortality if patient still have be admitted in hospital.

    Time frame: within 28 days after ICU admission to dead

Secondary outcomes

  1. Re Intubation Within 72 Hours

    Patient who need re-intubation within 72 hours

    Time frame: ICU complications up to 28 days after ICU admission

  2. Acute Kidney Injury

    New acute kidney injury in ICU

    Time frame: Acute kidney injury

07

Results

Posted Nov 7, 2014

Participant flow

Participant flow — Overall Study
MilestoneCohort Patient
Started602
Completed465
Not completed137

Outcome measures

PrimaryIn Hospital Mortality

28 days mortality if patient still have be admitted in hospital.

Time frame:
within 28 days after ICU admission to dead
Reported as:
Number · participants
In Hospital Mortality
participants</= 5%> 5%
In Hospital Mortality5244
SecondaryRe Intubation Within 72 Hours

Patient who need re-intubation within 72 hours

Time frame:
ICU complications up to 28 days after ICU admission
Reported as:
Number · participants
Re Intubation Within 72 Hours
participants</= 5%> 5%
Re Intubation Within 72 Hours1215
SecondaryAcute Kidney Injury

New acute kidney injury in ICU

Time frame:
Acute kidney injury
Reported as:
Number · participants
Acute Kidney Injury
participants</= 5%> 5%
Acute Kidney Injury6851

Adverse events

Collected over up to 28 days after ICU admission. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
</= 5%—11/306 (3.6%)38/306 (12.4%)
> 5%—19/159 (11.9%)37/159 (23.3%)
Most frequent serious events
Most frequent serious events
Event</= 5%> 5%
Renal replacement therapyRenal and urinary disorders11/30619/159
Most frequent other events
Most frequent other events
Event</= 5%> 5%
DeliriumNervous system disorders38/30637/159

Baseline characteristics

Age, Continuous
Age, Continuous(years)ICU SurvivorsICU Non SurvivorsTotal
Median60 (49 to 72)53 (45 to 74)60 (49 to 74)
Sex: Female, Male
Sex: Female, Male(Participants)ICU SurvivorsICU Non SurvivorsTotal
Female14831179
Male24739286
08

Study locations

1 site
  • Department of Surgery, Faculty of Medicine, Maharaj Nakorn Chiang Mai hospital
    Muang Chiang Mai, Chiang Mai 50200, Thailand
09

References and documents

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 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 7, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01351506
Lead sponsor
Chiang Mai University
Responsible party
Kaweesak Chittawatanarat (Department of Surgery, Chiang Mai University) — Principal investigator
First posted
May 11, 2011
Start date
May 2011
Primary completion
Aug 2012
Completion
Aug 2012
Results posted
Nov 7, 2014
Last update
Nov 7, 2014

Study contacts

Kaweesak Chittawatanarat Assistant Professor
principal investigator · Chaing Mai University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2014. You cannot join it, but the record below documents what was studied.

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