Effect of Body Weight Change to Surgical ICU Outcomes

Body Weight Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01351506
• Other study ID #: 10FEB010924
• Status: Completed
• Phase: N/A
• First received: May 9, 2011
• Last updated: November 3, 2014
• Start date: May 2011
• Est. completion date: August 2012

Study information

• Verified date: November 2014
• Source: Chiang Mai University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Observational

Clinical 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 465
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Body Weight
• Body Weight Changes
• Weight Change

Locations

Country	Name	City	State
Thailand	Department of Surgery, Faculty of Medicine, Maharaj Nakorn Chiang Mai hospital	Muang Chiang Mai	Chiang Mai

Sponsors (1)

Lead Sponsor	Collaborator
Chiang Mai University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	In Hospital Mortality	28 days mortality if patient still have be admitted in hospital.	within 28 days after ICU admission to dead	No
Secondary	Re Intubation Within 72 Hours	Patient who need re-intubation within 72 hours	ICU complications up to 28 days after ICU admission	No
Secondary	Acute Kidney Injury	New acute kidney injury in ICU	Acute kidney injury	Yes