Total Parenteral Infusion (TPN)-Induced Hyperglycemia: Impact on Clinical Outcome in ICU and Non-ICU Patients - Full Text View

Sponsored by:	Emory University
Information provided by:	Emory University
ClinicalTrials.gov Identifier:	NCT00604669

Purpose

A growing body of evidence suggests hyperglycemia is associated with adverse outcomes in patients with and without diabetes. Observational studies document an association between hyperglycemia and poor clinical outcomes in cardiothoracic surgery, elective surgery, myocardial infarction, stroke. Randomized studies indicate glycemic control is associated with improved outcomes in diabetic patients with critically illness. Hyperglycemia is a recognized and common complication of patients receiving total parenteral nutrition (TPN). Few studies in the literature have looked into the impact of TPN-associated inhospital complications and mortality. Accordingly, this study aims to evaluate the impact of hyperglycemia on clinical outcome (infections, systemic sepsis, cardiac complications, acute renal failure, length of stay, and mortality) in patients receiving TPN. We will perform a retrospective chart review of all patients treated with TPN from 1/01/06 to 12/31/06 at Grady Memorial Hospital. We hypothesize that patients receiving TPN who develop hyperglycemia experience higher morbidity (infections, systemic sepsis, cardiac complications, acute renal failure, length of stay) and mortality compared to TPN patients with euglycemia. The results of this study will help us to formulate a prospective randomized clinical trial on the management of TPN-associated hyperglycemia in hospitalized patients.

This study aims to evaluate the impact of hyperglycemia on clinical outcome (infections, systemic sepsis, cardiac complications, acute renal failure, length of stay, in hospital mortality) in patients receiving total parenteral nutrition. We will perform a retrospective chart review of all patients admitted to the hospital receiving TPN from 1/01/06 to 12/31/06 at Grady Memorial Hospital. The results of this study will help us to formulate a prospective randomized clinical trial on the management of TPN-associated hyperglycemia in hospitalized patients.

Hypotheses:

We hypothesize that patients receiving TPN who develop hyperglycemia experience higher morbidity (infections, systemic sepsis, cardiac complications, acute renal failure, length of stay) and mortality compared to TPN patients with euglycemia.

Specific Aim:

To determine the impact of hyperglycemia on clinical outcome (infection, systemic sepsis, cardiac complications, acute renal failure, length of stay, mortality) in patients receiving total parenteral nutrition.

Condition
Hyperglycemia

MedlinePlus related topics: Sepsis

U.S. FDA Resources

Study Type:	Observational
Study Design:	Retrospective
Official Title:	Total Parenteral Infusion(TPN)-Induced Hyperglycemia: Impact on Clinical Outcome in Intensive Care Unit (ICU) and Non-ICU Patients

Further study details as provided by Emory University:

Primary Outcome Measures:

The primary outcome of the study is to determine in-hospital mortality rate of patients with hyperglycemia receiving TPN. [ Time Frame: once all charts have been reviewed ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Demographics and clinical outcome measures will be compared between patients who experienced hyperglycemia during TPN treatment and those who maintained normal blood glucose concentration. [ Time Frame: once all charts have been reviewed ] [ Designated as safety issue: Yes ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	200
Study Start Date:	June 2007
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Eligibility

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

Study Population

All patients receiving TPN at Grady Memorial Hospital during the period of 1/01/06 to 12/31/06.

Criteria

Inclusion Criteria:

Patients receiving TPN at Grady Memorial Hospital

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00604669

Contacts

Contact: Guillermo Umpierrez, MD	404.778.1665	geumpie@emory.edu
Contact: Dawn Smiley, MD	404.778.1664	dsmiley@emory.edu

Locations

United States, Georgia
Grady Memorial Hospital	Recruiting
Atlanta, Georgia, United States, 30303
Contact: Guillermo Umpierrez, MD 404-778-1661 geumpie@emory.edu
Contact: Dawn Smiley, MD 404.778.1664 dsmiley@emory.edu

Sponsors and Collaborators

Emory University

Investigators

Principal Investigator:

Guillermo Umpierrez, MD

Emory University SOM

More Information

Responsible Party:	Emory University School of Medicine ( Guillermo Umpierrez, MD )
Study ID Numbers:	e4573, e4573
Study First Received:	January 17, 2008
Last Updated:	October 7, 2008
ClinicalTrials.gov Identifier:	NCT00604669
Health Authority:	United States: Institutional Review Board

Keywords provided by Emory University:

Diabetes
Nutrition/Dietics
clinical outcomes
total parenteral nutrition

Study placed in the following topic categories:

Metabolic Diseases
Hyperglycemia
Diabetes Mellitus
Metabolic disorder
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on January 14, 2009