LOGIC-Insulin Algorithm-guided Versus Nurse-directed Blood Glucose Control During Critical Illness (LOGIC-1)

This study has been completed.
Sponsor:
Collaborators:
Agency for Innovation by Science and Technology, Flanders, Belgium
Fund for Scientific Research, Flanders, Belgium
Information provided by (Responsible Party):
Greet Van den Berghe, Katholieke Universiteit Leuven
ClinicalTrials.gov Identifier:
NCT01420302
First received: August 17, 2011
Last updated: July 31, 2012
Last verified: July 2012
  Purpose

The LOGIC-Insulin computerized software algorithm will be compared with a nurse-directed protocol, both targeting a blood glucose level of 80-110 mg/dL, in critically ill patients


Condition Intervention Phase
Critical Illness
Procedure: Nurse directed insulin titration
Procedure: LOGIC-Insulin
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: LOGIC-Insulin Computerized Algorithm-guided Versus Nurse-directed Blood Glucose Control in Critically Ill Patients: the LOGIC-1 Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Katholieke Universiteit Leuven:

Primary Outcome Measures:
  • Glycemic Penalty Index (GPI) during the intervention [ Time Frame: up to 14 days post-randomization ] [ Designated as safety issue: No ]
    Adequacy of reaching and maintaining the target range for blood glucose during the intervention


Secondary Outcome Measures:
  • Proportion of patients with severe hypoglycemia (<40 mg/dL) during the intervention [ Time Frame: up to 14 days post-randomization ] [ Designated as safety issue: Yes ]
    Proportion of patients to have had one or more episodes of severe hypoglycemia (<40 mg/dL) during the intervention

  • Incidence of severe hypoglycemia (<40 mg/dL) during the intervention [ Time Frame: up to 14 days post-randomization ] [ Designated as safety issue: Yes ]
    Number of severe hypoglycemic values as a fraction of all blood glucose measurements during the intervention

  • Blood glucose level per treatment group during the intervention [ Time Frame: up to 14 days post-randomization ] [ Designated as safety issue: No ]
  • Hyperglycemic index (HGI) during the intervention [ Time Frame: up to 14 days post-randomization ] [ Designated as safety issue: No ]
    Adequacy of reaching and maintaining the target range for blood glucose during the intervention

  • Daily maximal blood glucose difference during the intervention [ Time Frame: up to 14 days post-randomization ] [ Designated as safety issue: No ]
    Marker of blood glucose variability

  • Proportion of patients with common hypoglycemia (<60 mg/dL) during the intervention [ Time Frame: up to 14 days post-randomization ] [ Designated as safety issue: No ]
    Proportion of patients to have had one or more episodes of common hypoglycemia during the intervention

  • Interval between blood glucose measurements during the intervention [ Time Frame: up to 14 days post-randomization ] [ Designated as safety issue: No ]
    Marker of workload

  • Percentage of time in target zone (80-110 mg/dL) during the intervention [ Time Frame: up to 14 days post-randomization ] [ Designated as safety issue: No ]
    Adequacy of reaching and maintaining the target range for blood glucose during the intervention

  • Length of stay in ICU [ Time Frame: up to 90 days post-randomization ] [ Designated as safety issue: No ]
  • Length of stay in hospital [ Time Frame: up to 90 days post-randomization ] [ Designated as safety issue: No ]
  • Hospital mortality [ Time Frame: up to 90 days post-randomization ] [ Designated as safety issue: No ]
    Patients who will have been discharged from hospital before 90 days post-randomization will be regarded as survivors

  • Incidence of common hypoglycemia (<60 mg/dL) during the intervention [ Time Frame: up to 14 days post-randomization ] [ Designated as safety issue: No ]
    Number of common hypoglycemic values as a fraction of all blood glucose measurements during the intervention


Enrollment: 300
Study Start Date: August 2011
Study Completion Date: March 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LOGIC-Insulin
Blood glucose control (80-110 mg/dL) guided by the LOGIC-Insulin algorithm
Procedure: LOGIC-Insulin
Blood glucose control (80-110 mg/dL) guided by the LOGIC-Insulin algorithm
Other Name: software guided TGC
Active Comparator: Nurse-directed
Nurse-directed blood glucose control (80-110 mg/dL)
Procedure: Nurse directed insulin titration
Nurse directed insulin titration to establish glycemic control in the target range of 80-110 mg/dL
Other Name: Active comparator: titration-guidelines supported TGC

Detailed Description:

Critical illness typically causes elevated blood glucose concentrations, which have been associated with increased mortality. Strictly normalizing these blood glucose levels by intensive insulin therapy, called tight glycemic control, decreased morbidity and mortality in well-controlled single-center clinical studies. However, multi-center pragmatic trials failed to reproduce those effects, proving that the implementation of tight glycemic control in daily clinical practice is rather difficult.

A computerized algorithm, amongst others, may help the nurses in the titration of insulin to reach normal blood glucose levels and to avoid the particularly worrisome hypoglycemia.

The LOGIC-1 study is a single blinded randomized controlled trial. On admission patients will be randomly assigned to either tight glycemic control (80-110 mg/dL) by the computerized LOGIC-Insulin 3.0 algorithm or to tight glycemic control (80-110 mg/dL) by the nurse-directed protocol. Written informed consent will be asked from the patient in the case of elective surgery requiring post-operative ICU-admission. Proxy informed consent from the closest family member will be asked when the patient was admitted to the ICU in emergency. As blood glucose control by itself is essential in the management of critical illness, random allocation will be done on admission and written informed consent from the closest family member can be deferred to a maximum of 24 hours after randomization. The patient or family member can at all times withdraw from the trial without impact on his treatment. Allocation will be done in blocks (block size is unknown to the care givers responsible for treatment allocation), stratified into cardiac surgery and other reasons for ICU admission, by central computer randomization.

The time window for the study will be 14 days starting from admission to the ICU or when one of the following stop criteria will be met:

  • Withdrawal of the informed consent
  • Patient starts eating or drinking sugar containing liquids
  • Patient is discharged from the ICU (including ICU deaths)
  • Removal of arterial line or central venous line

Under the following conditions the study investigator/treating physician will be contacted and, if necessary, patients will be switched from LOGIC-Insulin to nurse-directed blood glucose control:

  • Recurrent severe hypoglycemia (<40 mg/dL)
  • Refractory hyperglycemia
  • Any change in condition that compromises the safety of the patient, as judged by the investigator or treating physician

The common strategy for blood glucose control in both groups involves blood glucose measurements from arterial blood by a blood gas analyzer and the administration of insulin through a central line with a syringe pump.

  Eligibility

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

Inclusion Criteria:

  • Aged 18 years or more
  • Admitted to the ICU
  • Already receiving or needing insulin infusion for blood glucose control

Exclusion Criteria:

  • Not critically ill (eating, not mechanically ventilated)
  • Pregnant or breastfeeding
  • Previous inclusion into the trial
  • Included in other trial
  • Moribund
  • Diabetes coma
  • No arterial line available
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01420302

Locations
Belgium
Dept Intensive Care Medicine, University Hospitals Leuven
Leuven, Belgium, 3000
Sponsors and Collaborators
Greet Van den Berghe
Agency for Innovation by Science and Technology, Flanders, Belgium
Fund for Scientific Research, Flanders, Belgium
Investigators
Study Director: Dieter Mesotten, MD, PhD Katholieke Universiteit Leuven
Principal Investigator: Greet Van den Berghe, MD, PhD Katholieke Universiteit Leuven
Principal Investigator: Tom Van Herpe, Eng, PhD Katholieke Universiteit Leuven
Principal Investigator: Bart De Moor, Eng, PhD Katholieke Universiteit Leuven
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Greet Van den Berghe, Head of Dept Intensive Care Medicine, Katholieke Universiteit Leuven
ClinicalTrials.gov Identifier: NCT01420302     History of Changes
Other Study ID Numbers: LOGIC-Insulin 1.1.1., S 51956, 80M0437, ML 6079
Study First Received: August 17, 2011
Last Updated: July 31, 2012
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by Katholieke Universiteit Leuven:
critical illness
intensive care
insulin
glucose
algorithm
blood glucose control

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 July 20, 2014