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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Influence of Tightly Glucose Control on Hyperglycemic Toxicity and Protein

Conditions
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Critically Ill Patients

Intervention / Treatment
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* Other: Tightly glucose control
* Other: Conventional glucose control


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tightly glucose conntrol<br> | Other: Tightly glucose control<br>* 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<br>* Other names: euglycemic control;|
| Active Comparator: Conventional glucose control<br> | Other: Conventional glucose control<br>* 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.<br>* Other names: conventional insulin therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 24-hour urinary urea nitrogen(UUN)excretion, nitrogen balance and serum albumin and prealbumin. |  | up to the 14th study day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ICU day, ventilator day, hospital day, episodes of acute renal injury, bacteremia, blood transfusion, gastrointestinal (GI) bleeding, hypoglycemia, and hospital mortality rate. |  | up to ICU discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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critical care, glycemic control, insulin, nitrogen balance