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Comparing Two Ways of Controlling Blood Sugar With Insulin in Patients Admitted to the Intensive Care Unit
Plain-language guide to NCT00166491: not phased randomized trial of Insulin (regular human), 238 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00166491
- Phase
- not phased
- Status
- completed
- Start
- 2005-07
- Completion (planned or actual)
- 2007-03
- Participants
- 238 (actual)
- Design
- randomized, single-blind, treatment
- Conditions studied
- Critical Illness; Hyperglycemia
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered not phased trial tested Insulin (regular human).
The purpose of this study is to determine if there is any difference between two ways of controlling blood sugar with insulin.
In patients admitted to the intensive care unit, blood sugar levels often rise due to the stress of illness or surgery.
The registry classes the interventions as drug.
More on the Plan
A number of look-up algorithms based on hourly glucose measurements and titrated intravenous insulin have been developed for the intensive care unit (ICU).
Despite the numerous published algorithms, no study has investigated which algorithm results in optimal glycemic control in critically ill patients.
The purpose of this trial is to compare two institutionally approved intravenous insulin administration algorithms and describe subsequent glycemic control.
Optimal glycemic control will be defined by time spent within a predetermined blood glucose range.
Who Took Part
The registry lists 238 actual participants took part.
It was open to people of any sex aged from 21 years with no upper age limit.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: All patients admitted to the 7MB D/E ICU will be eligible for this study.
The full record lists 1 inclusion and 0 exclusion criteria.
How the Study Was Run
It was run as a randomized, parallel-group and single-blind study.
Random assignment meant chance, not the researchers, decided who got Insulin (regular human) and who got the comparison, which limits bias.
Groups ran in parallel: each of the participants stayed in one arm throughout.
Only one side, usually the participants, was kept unaware of whether Insulin (regular human) was given.
It started in 2005-07 with completion listed for 2007-03.
It ran at 1 site in United States.
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): Mean blood glucose level during study period [mg/dl].
It also tracked 5 secondary outcomes, for example Time enrolled in the trial [hours] and Maximum blood glucose level during study period [mg/dl].
What This Means in Plain Language
Put simply, this is a not phased, randomized trial of Insulin (regular human) in 238 people.
The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Insulin (regular human) compound page, all human trials.
Our Notes on the Compound
Insulin (regular human): The 51-amino-acid pancreatic hormone that lowers blood glucose; this page covers regular (short-acting) insulin studied in human trials.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.