Effect of Body Weight Change to Surgical ICU Outcomes

• Sponsor: Chiang Mai University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01351506
• Collaborator: (none)
• Enrollment: 465
• Location: 1
• Duration (Months): 15
• Patients Per Site Per Month: 30.9

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Body Weight; Weight Change

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

• Study Type: Observational
• Actual Enrollment: 465 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Effect and Determinant Level of Admission Body Weight and Daily Weight Change and Prognoses of Critically and High Risk Surgical Patients
• Study Start Date: May 1, 2011
• Actual Primary Completion Date: Aug 1, 2012
• Actual Study Completion Date: Aug 1, 2012

Outcome Measures

Primary Outcome Measures

1. In Hospital Mortality [within 28 days after ICU admission to dead]

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

Secondary Outcome Measures

1. Re Intubation Within 72 Hours [ICU complications up to 28 days after ICU admission]

   Patient who need re-intubation within 72 hours

2. Acute Kidney Injury [Acute kidney injury]

   New acute kidney injury in ICU

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Surgery, Faculty of Medicine, Maharaj Nakorn Chiang Mai hospital	Muang Chiang Mai	Chiang Mai	Thailand	50200

Sponsors and Collaborators

• Chiang Mai University

Investigators

• Principal Investigator: Kaweesak Chittawatanarat Assistant Professor, Chaing Mai University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kaweesak Chittawatanarat, Department of Surgery, Chiang Mai University
• ClinicalTrials.gov Identifier: NCT01351506
• Other Study ID Numbers: 10FEB010924
• First Posted: May 11, 2011
• Last Update Posted: Nov 7, 2014
• Last Verified: Nov 1, 2014

• Keywords provided by Kaweesak Chittawatanarat, Department of Surgery, Chiang Mai University: Body weight; Body mass index; Weight change; ICU outcomes
• Additional relevant MeSH terms: Body Weight; Body Weight Changes

Study Results

Participant Flow

Arm/Group Title	Cohort Patient
Arm/Group Description	A total of 602 patients as inclusion criteria between May 2011 and August 2012 were enrolled on the ICU admission (day 0). One hundred thirty seven patients were excluded due to a short stay in ICU or were not weighed a second time on day 1. The remainder of 465 patients were included and followed in this study.
Period Title: Overall Study
STARTED	602
COMPLETED	465
NOT COMPLETED	137

Baseline Characteristics

Arm/Group Title	ICU Survivors	ICU Non Survivors	Total
Arm/Group Description	Patients who survivors from ICU discharge status	Patients who non survivors from ICU discharge status	Total of all reporting groups
Overall Participants	395	70	465
Age (years) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [years]	60	53	60
Sex: Female, Male (Count of Participants)
Female	148 37.5%	31 44.3%	179 38.5%
Male	247 62.5%	39 55.7%	286 61.5%

Outcome Measures

1. Primary Outcome

Title	In Hospital Mortality
Description	28 days mortality if patient still have be admitted in hospital.
Time Frame	within 28 days after ICU admission to dead

Outcome Measure Data

Analysis Population Description

Total 465 patients

Arm/Group Title	</= 5%	> 5%
Arm/Group Description	Maximum weight change upto 7 days less than or equal to 5% of admission body weight	Maximum weight change upto 7 days more than 5% of admission weight
Measure Participants	306	159
Number [participants]	52 13.2%	44 62.9%

2. Secondary Outcome

Title	Re Intubation Within 72 Hours
Description	Patient who need re-intubation within 72 hours
Time Frame	ICU complications up to 28 days after ICU admission

Outcome Measure Data

Analysis Population Description

All

Arm/Group Title	</= 5%	> 5%
Arm/Group Description	Maximum weight change upto 7 days less than or equal to 5% of admission body weight	Maximum weight change upto 7 days more than 5% of admission weight
Measure Participants	306	159
Number [participants]	12 3%	15 21.4%

3. Secondary Outcome

Title	Acute Kidney Injury
Description	New acute kidney injury in ICU
Time Frame	Acute kidney injury

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	</= 5%	> 5%
Arm/Group Description	Maximum weight change upto 7 days less than or equal to 5% of admission body weight	Maximum weight change upto 7 days more than 5% of admission weight
Measure Participants	306	159
Number [participants]	68 17.2%	51 72.9%

Adverse Events

Time Frame	up to 28 days after ICU admission
Adverse Event Reporting Description	Events occurring within 28 days after ICU admission
Arm/Group Title	</= 5%		> 5%
Arm/Group Description	Maximum weight change upto 7 days less than or equal to 5% of admission body weight		Maximum weight change upto 7 days more than 5% of admission weight
All Cause Mortality
	</= 5%		> 5%
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	</= 5%		> 5%
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	11/306 (3.6%)		19/159 (11.9%)
Renal and urinary disorders
Renal replacement therapy	11/306 (3.6%)	11	19/159 (11.9%)	19
Other (Not Including Serious) Adverse Events
	</= 5%		> 5%
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	38/306 (12.4%)		37/159 (23.3%)
Nervous system disorders
Delirium	38/306 (12.4%)	38	37/159 (23.3%)	37

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.