Hyperglycemia Clinical Trial
Official title:
Total Parenteral Nutrition(TPN)-Induced Hyperglycemia: Impact on Clinical Outcome in Intensive Care Unit (ICU) and Non-ICU Patients
| Verified date | November 2013 |
| Source | Emory University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Institutional Review Board |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 170 |
| Est. completion date | August 2009 |
| Est. primary completion date | August 2009 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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. |
Time Perspective: Retrospective
| Country | Name | City | State |
|---|---|---|---|
| United States | Grady Memorial Hospital | Atlanta | Georgia |
| Lead Sponsor | Collaborator |
|---|---|
| Emory University |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Mortality | Mortality rate of those with hyperglycemia while on TPN duing the period of 1/01/06 to 12/31/06. | at the end of the chart review of all patients | Yes |
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