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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2012-03-31

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Critical Illness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Algorithm-guided versus Nurse directed Blood Glucose Control

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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LOGIC-Insulin

Blood glucose control (80-110 mg/dL) guided by the LOGIC-Insulin algorithm

Group Type EXPERIMENTAL

LOGIC-Insulin

Intervention Type PROCEDURE

Blood glucose control (80-110 mg/dL) guided by the LOGIC-Insulin algorithm

Nurse-directed

Nurse-directed blood glucose control (80-110 mg/dL)

Group Type ACTIVE_COMPARATOR

Nurse directed

Intervention Type PROCEDURE

Nurse directed insulin titration to establish glycemic control in the target range of 80-110 mg/dL

Interventions

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Nurse directed

Nurse directed insulin titration to establish glycemic control in the target range of 80-110 mg/dL

Intervention Type PROCEDURE

LOGIC-Insulin

Blood glucose control (80-110 mg/dL) guided by the LOGIC-Insulin algorithm

Intervention Type PROCEDURE

Other Intervention Names

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Active comparator: titration-guidelines supported TGC software guided TGC

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No