Influence of Tightly Glucose Control on Hyperglycemic Toxicity and Protein Catabolism in Critically Ill Patients - Full Text View

Purpose

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	Intervention	Phase
Critically Ill Patients	Other: Tightly glucose control Other: Conventional glucose control	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Influence of Tightly Glucose Control on Hyperglycemic Toxicity and Protein

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Medicines

Drug Information available for: Insulin human Dextrose

U.S. FDA Resources

Further study details as provided by Kaohsiung Veterans General Hospital.:

Primary Outcome Measures:

24-hour urinary urea nitrogen(UUN)excretion, nitrogen balance and serum albumin and prealbumin. [ Time Frame: up to the 14th study day ] [ Designated as safety issue: No ]

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. [ Time Frame: up to ICU discharge ] [ Designated as safety issue: Yes ]

Enrollment:	112
Study Start Date:	April 2006
Study Completion Date:	December 2006
Primary Completion Date:	December 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Arms

Assigned Interventions

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

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01227148

Locations

Taiwan
Kaohsiung Veterans General Hospital
Kaohsiung, Taiwan, 813

Sponsors and Collaborators

Kaohsiung Veterans General Hospital.

Investigators

Principal Investigator:

Chien-Wei Hsu, MD

Kaohsiung Veterans General Hospital.

More Information

No publications provided by Kaohsiung Veterans General Hospital.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	Chien-Wei Hsu, Kaohsiung Veterans General Hospital
ClinicalTrials.gov Identifier:	NCT01227148 History of Changes
Other Study ID Numbers:	VGHKS95-070
Study First Received:	October 15, 2010
Last Updated:	October 22, 2010
Health Authority:	Taiwan: Department of Health

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

Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013