Influence of Tightly Glucose Control on Hyperglycemic Toxicity and Protein Catabolism in Critically Ill Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01227148
Recruitment Status : Completed
First Posted : October 25, 2010
Last Update Posted : October 25, 2010
Information provided by:
Kaohsiung Veterans General Hospital.

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.

Condition or disease Intervention/treatment Phase
Critically Ill Patients Other: Tightly glucose control Other: Conventional glucose control Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 112 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Influence of Tightly Glucose Control on Hyperglycemic Toxicity and Protein
Study Start Date : April 2006
Primary Completion Date : December 2006
Study Completion Date : December 2006

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U.S. FDA Resources

Arm Intervention/treatment
Experimental: Tightly glucose conntrol Other: Tightly glucose control
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
Other Name: euglycemic control
Active Comparator: Conventional glucose control Other: Conventional glucose control
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.
Other Name: conventional insulin therapy

Primary Outcome Measures :
  1. 24-hour urinary urea nitrogen(UUN)excretion, nitrogen balance and serum albumin and prealbumin. [ Time Frame: up to the 14th study day ]

Secondary Outcome Measures :
  1. 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 ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01227148

Kaohsiung Veterans General Hospital
Kaohsiung, Taiwan, 813
Sponsors and Collaborators
Kaohsiung Veterans General Hospital.
Principal Investigator: Chien-Wei Hsu, MD Kaohsiung Veterans General Hospital.

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Chien-Wei Hsu, Kaohsiung Veterans General Hospital Identifier: NCT01227148     History of Changes
Other Study ID Numbers: VGHKS95-070
First Posted: October 25, 2010    Key Record Dates
Last Update Posted: October 25, 2010
Last Verified: April 2006

Keywords provided by Kaohsiung Veterans General Hospital.:
critical care, glycemic control, insulin, nitrogen balance

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs