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

NCT01227148 | Completed Phase 3 DMC

• 1 other identifier: VGHKS95-070
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

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.

Conditions

Critically Ill Patients

Keywords

critical care, glycemic control, insulin, nitrogen balance

Outcome Measures

Primary Outcomes (1)

• 24-hour urinary urea nitrogen(UUN)excretion, nitrogen balance and serum albumin and prealbumin.

  up to the 14th study day

Secondary Outcomes (1)

• 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

Study Arms (2)

Tightly glucose conntrol

EXPERIMENTAL

Other: Tightly glucose control

Conventional glucose control

ACTIVE COMPARATOR

Other: Conventional glucose control

Interventions

Tightly glucose control OTHER

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

Also known as: euglycemic control

Tightly glucose conntrol

Conventional glucose control OTHER

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.

Also known as: conventional insulin therapy

Conventional glucose control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• pregnant patients
• patients with chronic renal loss (Chronic renal loss was defined as persistent acute renal failure, complete loss of kidney function \> 4 weeks)

Sponsors & Collaborators

• Kaohsiung Veterans General Hospital.: lead

Study Sites (1)

Kaohsiung Veterans General Hospital

Kaohsiung City, 813, Taiwan

Location

Related Publications (2)

• Bellon F, Sola I, Gimenez-Perez G, Hernandez M, Metzendorf MI, Rubinat E, Mauricio D. Perioperative glycaemic control for people with diabetes undergoing surgery. Cochrane Database Syst Rev. 2023 Aug 1;8(8):CD007315. doi: 10.1002/14651858.CD007315.pub3.

  PMID: 37526194 DERIVED

• 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.

  PMID: 22480187 DERIVED

MeSH Terms

Conditions

Insulin Resistance

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Chien-Wei Hsu, MD

  Kaohsiung Veterans General Hospital.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 15, 2010
• First Posted: October 25, 2010
• Study Start: April 1, 2006
• Primary Completion: December 1, 2006
• Study Completion: December 1, 2006
• Last Updated: October 25, 2010

Record last verified: 2006-04

Locations

TW (1)