HyperglycemiaNCT00604669
TPN-Induced Hyperglycemia: Impact on Clinical Outcome in Intensive Care Unit (ICU) and Non-ICU Patients
An observational study of Hyperglycemia, run by Emory University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperglycemia
- How many people
- 170 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2007to Aug 2009
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients receiving TPN at Grady Memorial Hospital during the period of 1/01/06 to 12/31/06.
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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Total Parenteral Nutrition(TPN)-Induced Hyperglycemia: Impact on Clinical Outcome in Intensive Care Unit (ICU) and Non-ICU Patients
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.
Read the 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.
- Conditions
- Hyperglycemia
- Keywords
- Diabetes, Nutrition/Dietics, clinical outcomes, total parenteral nutrition
- Medical subject headings
- Hyperglycemia, Diabetes Mellitus, Hyperphagia
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Mortality rate of those with hyperglycemia while on TPN duing the period of 1/01/06 to 12/31/06.
Measured: at the end of the chart review of all patients
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2008 (estimated)
- Study startJun 2007
- Primary completionAug 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HyperglycemiaStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Retrospective
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guillermo Umpierrez, Emory University
- Investigators
- Guillermo Umpierrez, MD, Principal investigator, Emory University SOM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00604669
- Sponsor's protocol ID
- IRB00004573
- Other IDs
- e4573
- Status last verified
- Nov 2013
- First submitted
- 17 Jan 2008
- Last updated
- 13 Dec 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Total Parenteral Nutrition(TPN)-Induced Hyperglycemia: Impact on Clinical Outcome in Intensive Care Unit (ICU) and Non-ICU Patients
- ClinicalTrials.gov ID
- NCT00604669
- Acronym / sponsor ID
- IRB00004573
- Conditions
- Hyperglycemia
- Keywords
- Diabetes, Nutrition/Dietics, clinical outcomes, total parenteral nutrition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- Jun 2007
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 30 Jan 2008 (estimated)
- Results
- Posted 7 Apr 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients receiving TPN at Grady Memorial Hospital during the period of 1/01/06 to 12/31/06.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mortality
Time frame: at the end of the chart review of all patients
Mortality rate of those with hyperglycemia while on TPN duing the period of 1/01/06 to 12/31/06.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guillermo Umpierrez, MD principal investigator
Emory University SOM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyperglycemia, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Apr 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: at the end of the chart review of all patients). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2013.