Effect of Body Weight (BW), Body Mass Index (BMI) and BW Change to Surgical ICU Outcomes

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by Chiang Mai University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Chiang Mai University
ClinicalTrials.gov Identifier:
NCT01351506
First received: May 9, 2011
Last updated: May 26, 2011
Last verified: February 2010
  Purpose

Aims of study

  1. Effect of admission weight, body mass index to outcome of treatment in 28 days
  2. Effect of daily weight change upto 7 days from ICU admission to outcome of treatment in 28 days
  3. Comparation between daily intake/output and daily weight change
  4. Determination cutpoint of weight to outcome treatment

Condition
Body Weight
Weight Change

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effect and Determinant Level of Admission Body Weight, Body Mass Index and Daily Weight Change and Prognoses of Critically and High Risk Surgical Patients

Further study details as provided by Chiang Mai University:

Primary Outcome Measures:
  • In hospital mortality [ Time Frame: within 28 days after ICU admission to dead ] [ Designated as safety issue: Yes ]
    Inhospital mortality or 28 days mortality if patient still have be admitted in hospital.


Secondary Outcome Measures:
  • Complication [ Time Frame: ICU complications up to 28 days after ICU admission ] [ Designated as safety issue: Yes ]
    Infection Renal failure Heart failure Liver failure Coagulopathy Coma GI complication

  • Ventilator day [ Time Frame: Upto 1 year ] [ Designated as safety issue: Yes ]
    All count ventilator used in day(s)


Estimated Enrollment: 500
Study Start Date: May 2011
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

All admitted ICU patients which expected survive more than 24 hours. Patient were stratified into 3 groups for ICU administration preliminary as:

  1. Short ICU stay patient is the patient who admitted to ICU less than 48 hours.
  2. moderate ICU stay patient is the patient who admitted to ICU between 2-5 days
  3. long ICU stay patient is the patient who admitted to ICU more than 5 days
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01351506

Contacts
Contact: Kaweesak Chittawatanarat +6653945533 kchittaw@gmail.com

Locations
Thailand
Department of Surgery, Faculty of Medicine, Maharaj Nakorn Chiang Mai hospital Recruiting
Muang Chiang Mai, Chiang Mai, Thailand, 50200
Contact: Kaweesak Chittawatanarat, MD.FRCST    +6653945533    kchittaw@gmail.com   
Principal Investigator: Kaweesak Chittawatanarat         
Sponsors and Collaborators
Chiang Mai University
Investigators
Principal Investigator: Kaweesak Chittawatanarat Assistant Professor Chaing Mai University
  More Information

No publications provided

Responsible Party: Kaweesak Chittawatanarat, Department of Surgery, Faculty of Medicine, Chaing Mai University, Chiang Mai, Thailand
ClinicalTrials.gov Identifier: NCT01351506     History of Changes
Other Study ID Numbers: 10FEB010924
Study First Received: May 9, 2011
Last Updated: May 26, 2011
Health Authority: Thailand: Ethical Committee

Keywords provided by Chiang Mai University:
Body weight
Body mass index
Weight change
ICU outcomes

Additional relevant MeSH terms:
Body Weight
Body Weight Changes
Signs and Symptoms

ClinicalTrials.gov processed this record on August 21, 2014