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

Influence of Tightly Glucose Control on Hyperglycemic Toxicity and Protein

To compare the differences of urinary nitrogen excretion, nitrogen balance and clinical outcomes between tightly insulin therapy and conventional insulin therapy in the ICU.

Study Overview

• Status: Completed
• Conditions: Critically Ill Patients
• Intervention / Treatment: Other: Tightly glucose control; Other: Conventional glucose control

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
• Enrollment (Actual): 112
• Phase: Phase 3

Contacts and Locations

Study Locations

• Taiwan
  • Kaohsiung, Taiwan, 813
    • Kaohsiung Veterans General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: conventional insulin therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Kaohsiung Veterans General Hospital.
• Investigators: Principal Investigator: Chien-Wei Hsu, MD, Kaohsiung Veterans General Hospital.

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2006
• Primary Completion (Actual): December 1, 2006
• Study Completion (Actual): December 1, 2006

Study Registration Dates

• First Submitted: October 15, 2010
• First Submitted That Met QC Criteria: October 22, 2010
• First Posted (Estimate): October 25, 2010

Study Record Updates

• Last Update Posted (Estimate): October 25, 2010
• Last Update Submitted That Met QC Criteria: October 22, 2010
• Last Verified: April 1, 2006

More Information

Terms related to this study

• Keywords: critical care, glycemic control, insulin, nitrogen balance
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin
• Other Study ID Numbers: VGHKS95-070