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Effect of Body Weight Change to Surgical ICU Outcomes

Effect and Determinant Level of Admission Body Weight and Daily Weight Change and Prognoses of Critically and High Risk Surgical Patients

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01351506
Enrollment
465
Registered
2011-05-11
Start date
2011-05-31
Completion date
2012-08-31
Last updated
2014-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Body Weight, Weight Change

Keywords

Body weight, Body mass index, Weight change, ICU outcomes

Brief 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

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.

Interventions

None listed

Sponsors

Chiang Mai University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* All admitted ICU patients expected survive more than 24 hours

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
In Hospital Mortalitywithin 28 days after ICU admission to dead28 days mortality if patient still have be admitted in hospital.

Secondary

MeasureTime frameDescription
Re Intubation Within 72 HoursICU complications up to 28 days after ICU admissionPatient who need re-intubation within 72 hours
Acute Kidney InjuryAcute kidney injuryNew acute kidney injury in ICU

Countries

Thailand

Participant flow

Participants by arm

ArmCount
ICU Survivors
Patients who survivors from ICU discharge status
395
ICU Non Survivors
Patients who non survivors from ICU discharge status
70
Total465

Baseline characteristics

CharacteristicICU SurvivorsICU Non SurvivorsTotal
Age, Continuous60 years53 years60 years
Sex: Female, Male
Female
148 Participants31 Participants179 Participants
Sex: Female, Male
Male
247 Participants39 Participants286 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
38 / 30637 / 159
serious
Total, serious adverse events
11 / 30619 / 159

Outcome results

Primary

In Hospital Mortality

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

Time frame: within 28 days after ICU admission to dead

Population: Total 465 patients

ArmMeasureValue (NUMBER)
</= 5%In Hospital Mortality52 participants
> 5%In Hospital Mortality44 participants
Secondary

Acute Kidney Injury

New acute kidney injury in ICU

Time frame: Acute kidney injury

ArmMeasureValue (NUMBER)
</= 5%Acute Kidney Injury68 participants
> 5%Acute Kidney Injury51 participants
Secondary

Re Intubation Within 72 Hours

Patient who need re-intubation within 72 hours

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

Population: All

ArmMeasureValue (NUMBER)
</= 5%Re Intubation Within 72 Hours12 participants
> 5%Re Intubation Within 72 Hours15 participants

Source: ClinicalTrials.gov · Data processed: Mar 16, 2026