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

Critical Illness Clinical Trial

— LOGIC-1  

Official title:

LOGIC-Insulin Computerized Algorithm-guided Versus Nurse-directed Blood Glucose Control in Critically Ill Patients: the LOGIC-1 Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01420302
• Other study ID #: LOGIC-Insulin 1.1.1.
• Secondary ID: S 5195680M0437ML
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: August 17, 2011
• Last updated: July 31, 2012
• Start date: August 2011
• Est. completion date: March 2012

Study information

• Verified date: July 2012
• Source: Katholieke Universiteit Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: March 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness

Intervention

Procedure:
• Nurse directed insulin titration
Nurse directed insulin titration to establish glycemic control in the target range of 80-110 mg/dL
• LOGIC-Insulin
Blood glucose control (80-110 mg/dL) guided by the LOGIC-Insulin algorithm

Locations

Country	Name	City	State
Belgium	Dept Intensive Care Medicine, University Hospitals Leuven	Leuven

Sponsors (3)

Lead Sponsor	Collaborator
Greet Van den Berghe	Agency for Innovation by Science and Technology, Flanders, Belgium, Fund for Scientific Research, Flanders, Belgium

Country where clinical trial is conducted

Belgium, 

References & Publications (3)

van den Berghe G, Wouters P, Weekers F, Verwaest C, Bruyninckx F, Schetz M, Vlasselaers D, Ferdinande P, Lauwers P, Bouillon R. Intensive insulin therapy in critically ill patients. N Engl J Med. 2001 Nov 8;345(19):1359-67. — View Citation

Van Herpe T, De Brabanter J, Beullens M, De Moor B, Van den Berghe G. Glycemic penalty index for adequately assessing and comparing different blood glucose control algorithms. Crit Care. 2008;12(1):R24. doi: 10.1186/cc6800. Epub 2008 Feb 26. — View Citation

Van Herpe T, De Moor B, Van den Berghe G. Towards closed-loop glycaemic control. Best Pract Res Clin Anaesthesiol. 2009 Mar;23(1):69-80. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycemic Penalty Index (GPI) during the intervention	Adequacy of reaching and maintaining the target range for blood glucose during the intervention	up to 14 days post-randomization
Secondary	Proportion of patients with severe hypoglycemia (<40 mg/dL) during the intervention	Proportion of patients to have had one or more episodes of severe hypoglycemia (<40 mg/dL) during the intervention	up to 14 days post-randomization
Secondary	Incidence of severe hypoglycemia (<40 mg/dL) during the intervention	Number of severe hypoglycemic values as a fraction of all blood glucose measurements during the intervention	up to 14 days post-randomization
Secondary	Blood glucose level per treatment group during the intervention		up to 14 days post-randomization
Secondary	Hyperglycemic index (HGI) during the intervention	Adequacy of reaching and maintaining the target range for blood glucose during the intervention	up to 14 days post-randomization
Secondary	Daily maximal blood glucose difference during the intervention	Marker of blood glucose variability	up to 14 days post-randomization
Secondary	Proportion of patients with common hypoglycemia (<60 mg/dL) during the intervention	Proportion of patients to have had one or more episodes of common hypoglycemia during the intervention	up to 14 days post-randomization
Secondary	Interval between blood glucose measurements during the intervention	Marker of workload	up to 14 days post-randomization
Secondary	Percentage of time in target zone (80-110 mg/dL) during the intervention	Adequacy of reaching and maintaining the target range for blood glucose during the intervention	up to 14 days post-randomization
Secondary	Length of stay in ICU		up to 90 days post-randomization
Secondary	Length of stay in hospital		up to 90 days post-randomization
Secondary	Hospital mortality	Patients who will have been discharged from hospital before 90 days post-randomization will be regarded as survivors	up to 90 days post-randomization
Secondary	Incidence of common hypoglycemia (<60 mg/dL) during the intervention	Number of common hypoglycemic values as a fraction of all blood glucose measurements during the intervention	up to 14 days post-randomization

External Links

•   Leuven Laboratory Intensive Care Medicine