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Trial record 13 of 68 for:    tpn

TPN-Induced Hyperglycemia: Impact on Clinical Outcome in Intensive Care Unit (ICU) and Non-ICU Patients

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ClinicalTrials.gov Identifier: NCT00604669
Recruitment Status : Completed
First Posted : January 30, 2008
Results First Posted : April 7, 2010
Last Update Posted : December 13, 2013
Sponsor:
Information provided by (Responsible Party):
Guillermo Umpierrez, Emory University

Study Type Observational
Study Design Time Perspective: Retrospective
Condition Hyperglycemia
Enrollment 170
Recruitment Details 170 charts reviewed
Pre-assignment Details Nothing to disclose.
Arm/Group Title Those Exposed to TPN
Hide Arm/Group Description [Not Specified]
Period Title: Overall Study
Started 170
Completed 163
Not Completed 7
Reason Not Completed
lack of information in chart             7
Arm/Group Title Those Exposed to TPN
Hide Arm/Group Description [Not Specified]
Overall Number of Baseline Participants 163
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 163 participants
<=18 years
4
   2.5%
Between 18 and 65 years
120
  73.6%
>=65 years
39
  23.9%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 163 participants
60  (17)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 163 participants
Female
57
  35.0%
Male
106
  65.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 163 participants
163
1.Primary Outcome
Title Mortality
Hide Description Mortality rate of those with hyperglycemia while on TPN duing the period of 1/01/06 to 12/31/06.
Time Frame at the end of the chart review of all patients
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Those Exposed to TPN
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 163
Measure Type: Number
Unit of Measure: mortality rate
36
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Those Exposed to TPN
Hide Arm/Group Description [Not Specified]
All-Cause Mortality
Those Exposed to TPN
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Those Exposed to TPN
Affected / at Risk (%)
Total   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Those Exposed to TPN
Affected / at Risk (%)
Total   0/0 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Guillermo Umpierrez
Organization: Emory University
Phone: 404-778-1665
EMail: geumpie@emory.edu
Layout table for additonal information
Responsible Party: Guillermo Umpierrez, Emory University
ClinicalTrials.gov Identifier: NCT00604669     History of Changes
Other Study ID Numbers: IRB00004573
e4573 ( Other Identifier: Assigned Emory IRB number )
First Submitted: January 17, 2008
First Posted: January 30, 2008
Results First Submitted: December 8, 2008
Results First Posted: April 7, 2010
Last Update Posted: December 13, 2013