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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00604669
Enrollment
170
Registered
2008-01-30
Start date
2007-06-30
Completion date
2009-08-31
Last updated
2013-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperglycemia

Keywords

Diabetes, Nutrition/Dietics, clinical outcomes, total parenteral nutrition

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.

Interventions

None listed

Sponsors

Emory University
Lead SponsorOTHER

Study design

Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Mortalityat the end of the chart review of all patientsMortality rate of those with hyperglycemia while on TPN duing the period of 1/01/06 to 12/31/06.

Countries

United States

Participant flow

Recruitment details

170 charts reviewed

Pre-assignment details

Nothing to disclose.

Participants by arm

ArmCount
Those Exposed to TPN163
Total163

Withdrawals & dropouts

PeriodReasonFG000
Overall Studylack of information in chart7

Baseline characteristics

CharacteristicThose Exposed to TPN
Age, Categorical
<=18 years
4 Participants
Age, Categorical
>=65 years
39 Participants
Age, Categorical
Between 18 and 65 years
120 Participants
Age, Continuous60 years
STANDARD_DEVIATION 17
Region of Enrollment
United States
163 participants
Sex: Female, Male
Female
57 Participants
Sex: Female, Male
Male
106 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
0 / 0
serious
Total, serious adverse events
0 / 0

Outcome results

Primary

Mortality

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

ArmMeasureValue (NUMBER)
Those Exposed to TPNMortality36 mortality rate

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026