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

Critically Ill Patients Clinical Trial

Official title:

Influence of Tightly Glucose Control on Hyperglycemic Toxicity and Protein

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01227148
• Other study ID #: VGHKS95-070
• Status: Completed
• Phase: Phase 3
• First received: October 15, 2010
• Last updated: October 22, 2010
• Start date: April 2006
• Est. completion date: December 2006

Study information

• Verified date: April 2006
• Source: Kaohsiung Veterans General Hospital.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: December 2006
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Critical Illness
• Critically Ill Patients

Intervention

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
• 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.

Locations

Country	Name	City	State
Taiwan	Kaohsiung Veterans General Hospital	Kaohsiung

Sponsors (1)

Lead Sponsor	Collaborator
Kaohsiung Veterans General Hospital.

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	24-hour urinary urea nitrogen(UUN)excretion, nitrogen balance and serum albumin and prealbumin.		up to the 14th study day	No
Secondary	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	Yes