Influence of Tightly Glucose Control on Hyperglycemic Toxicity and Protein Catabolism in Critically Ill Patients
Primary Purpose
Critically Ill Patients
Status
Completed
Phase
Phase 3
Locations
Taiwan
Study Type
Interventional
Intervention
Tightly glucose control
Conventional glucose control
Sponsored by
About this trial
This is an interventional treatment trial for Critically Ill Patients focused on measuring critical care, glycemic control, insulin, nitrogen balance
Eligibility Criteria
Inclusion Criteria:
- Patients admitted to the adult ICU who had baseline blood glucose > 180 mg/dl
- expected to require treatment in the ICU on 3 or more consecutive days.
Exclusion Criteria:
- pregnant patients
- patients with chronic renal loss (Chronic renal loss was defined as persistent acute renal failure, complete loss of kidney function > 4 weeks)
Sites / Locations
- Kaohsiung Veterans General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Tightly glucose conntrol
Conventional glucose control
Arm Description
Outcomes
Primary Outcome Measures
24-hour urinary urea nitrogen(UUN)excretion, nitrogen balance and serum albumin and prealbumin.
Secondary Outcome Measures
ICU day, ventilator day, hospital day, episodes of acute renal injury, bacteremia, blood transfusion, gastrointestinal (GI) bleeding, hypoglycemia, and hospital mortality rate.
Full Information
NCT ID
NCT01227148
First Posted
October 15, 2010
Last Updated
October 22, 2010
Sponsor
Kaohsiung Veterans General Hospital.
1. Study Identification
Unique Protocol Identification Number
NCT01227148
Brief Title
Influence of Tightly Glucose Control on Hyperglycemic Toxicity and Protein Catabolism in Critically Ill Patients
Official Title
Influence of Tightly Glucose Control on Hyperglycemic Toxicity and Protein
Study Type
Interventional
2. Study Status
Record Verification Date
April 2006
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
December 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Kaohsiung Veterans General Hospital.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To compare the differences of urinary nitrogen excretion, nitrogen balance and clinical outcomes between tightly insulin therapy and conventional insulin therapy in the ICU.
Detailed Description
Critical illness is associated with increased circulating concentrations of proinflammatory cytokines, such as tumor necrosis factor (TNF-α), interleukin (IL)-1, and IL-6 which may be important mediators of insulin resistance and results in hyperglycemia. Altered glucose metabolism was caused by release of counter regulatory hormones such as glucagons; epinephrine and cortisol oppose the normal action of insulin, leading to an increase in skeletal muscle proteolysis. It did not know whether tightly glucose control had beneficial effect in urinary nitrogen excretion and nitrogen balance.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critically Ill Patients
Keywords
critical care, glycemic control, insulin, nitrogen balance
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
112 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tightly glucose conntrol
Arm Type
Experimental
Arm Title
Conventional glucose control
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Tightly glucose control
Other Intervention Name(s)
euglycemic control
Intervention Description
A continuous insulin infusion (50 IU of Actrapid HM) in 49.5 ml of 0.9 percent sodium chloride with the use of a pump was started when blood glucose level exceeded 140 mg/dl to maintain a blood glucose level of between 120 and 140 mg per deciliter. The dose of insulin was adjusted according to whole-blood glucose levels, measured at one-four-hour interval in arterial blood or arterial catheter was not available. The insulin dose was adjusted by a neuro-fuzzy method
Intervention Type
Other
Intervention Name(s)
Conventional glucose control
Other Intervention Name(s)
conventional insulin therapy
Intervention Description
a continuous insulin infusion was delivered when the blood glucose level exceeded 200 mg/dl and insulin level was then adjusted to maintain a blood glucose level of between 180 and 200 mg per deciliter.
Primary Outcome Measure Information:
Title
24-hour urinary urea nitrogen(UUN)excretion, nitrogen balance and serum albumin and prealbumin.
Time Frame
up to the 14th study day
Secondary Outcome Measure Information:
Title
ICU day, ventilator day, hospital day, episodes of acute renal injury, bacteremia, blood transfusion, gastrointestinal (GI) bleeding, hypoglycemia, and hospital mortality rate.
Time Frame
up to ICU discharge
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients admitted to the adult ICU who had baseline blood glucose > 180 mg/dl
expected to require treatment in the ICU on 3 or more consecutive days.
Exclusion Criteria:
pregnant patients
patients with chronic renal loss (Chronic renal loss was defined as persistent acute renal failure, complete loss of kidney function > 4 weeks)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chien-Wei Hsu, MD
Organizational Affiliation
Kaohsiung Veterans General Hospital.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaohsiung Veterans General Hospital
City
Kaohsiung
ZIP/Postal Code
813
Country
Taiwan
12. IPD Sharing Statement
Citations:
PubMed Identifier
22480187
Citation
Hsu CW, Sun SF, Lin SL, Huang HH, Wong KF. Moderate glucose control results in less negative nitrogen balances in medical intensive care unit patients: a randomized, controlled study. Crit Care. 2012 Dec 12;16(2):R56. doi: 10.1186/cc11299.
Results Reference
derived
Learn more about this trial
Influence of Tightly Glucose Control on Hyperglycemic Toxicity and Protein Catabolism in Critically Ill Patients
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