Clinical trial NCT00604669: TPN-Induced Hyperglycemia: Impact on Clinical Outcome in Intensive Care Unit (ICU) and Non-ICU Patients
Official title: Total Parenteral Nutrition(TPN)-Induced Hyperglycemia: Impact on Clinical Outcome in Intensive Care Unit (ICU) and Non-ICU Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hyperglycemia
Keywords: Diabetes
Nutrition/Dietics
clinical outcomes
total parenteral nutrition
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2008-01-30
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
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.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria: Perform a retrospective chart analysis of all patients receiving TPN at Grady Memorial Hospital during the period of 1/01/06 to 12/31/06.

Exclusion criteria: None except for charts without adequate data sufficient for chart review.

Primary outcomes:
measure: Mortality
timeFrame: at the end of the chart review of all patients
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Grady Memorial Hospital
state: Georgia
Study officials:
affiliation: Emory University SOM
name: Guillermo Umpierrez, MD
role: PRINCIPAL_INVESTIGATOR
References: