Medical ICU Paper-based Dynamic Insulin Protocol
- Conditions
- Stress Hyperglycemia
- Interventions
- Other: dynamic insulin protocolOther: static insulin protocol
- Registration Number
- NCT02847104
- Lead Sponsor
- University Hospital, Caen
- Brief Summary
Intensive care unit (ICU) patients commonly display hyperglycemia, even without previously known diabetes. It was demonstrated that hyperglycemia was associated with increased hospital mortality in various medical and surgical ICU situations. However, discrepant results from recent randomized, clinical trials of tight blood glucose control in ICUs have not allowed conclusions regarding whether there is a causal link between hyperglycemia and ICU mortality. In addition to the mean blood glucose level, glucose variability has recently been emphasized as an independent predictor of ICU and hospital mortality. This concept has been described in a wide variety of medical, surgical and trauma ICU patients. In all of these settings, glycemic variability was measured with various indices but was steadily associated with ICU and/or hospital mortality in non-diabetic ICU patients. Conversely, glycemic variability was either weakly or not associated with mortality in ICU patients with previously known diabetes. Notably, all of these data have been observational, and interventional trials remain lacking to assess the impact of glycemic variability reduction on ICU mortality and thus to demonstrate causality. However, glycemic variability was considered sufficiently important to be mentioned in recent international guidelines for the management of hyperglycemia in critically ill patients. In these publications, experts from the American College of Critical Care Medicine emphasized that glycemia should be maintained at less than 9.9 mmol/L in ICU patients while avoiding hypoglycemia and minimizing glycemic variability. To achieve these goals, computer-based insulin infusion protocols have demonstrated their superiority to paper-based protocols. Glucose concentrations, variation per unit of time between the last and current glucose measurements, insulin dosage, and carbohydrate intake were the main input variables used in these different computerized algorithms. However, such protocols are not widely available because commercial systems have licensing fees and academic protocols do not always go beyond the pilot phase.
To address this issue, the investigators adapted a previously validated, paper-based, dynamic protocol (DP) to an actual recommended glycemic target range. Our aim was to assess the efficacy, safety, feasibility and acceptance by nurses of this dynamic insulin protocol, compared to a paper-based, sliding scale static protocol (SP).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 131
- Male or female adult patient admitted to intensive care unit
- Intensive care unit stay > 48 hours
- Stress hyperglycemia above 9.9 mmil/L indicating the need of continuous intravenous insulin infusion
- Previous diabetes
- Acute metabolic event (ketoacidosis or hyperosmolarity)
- Insulin/dextrose infusion for hyperkalemia treatment
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description dynamic insulin protocol dynamic insulin protocol patients received intravenous insulin infusion according to a dynamic insulin protocol static insulin protocol static insulin protocol patients received intravenous insulin infusion according to a static insulin protocol
- Primary Outcome Measures
Name Time Method MAGE (mean amplitude of glycemic excursion) index calculated during the 5 first days after beginning of insulin infusion
- Secondary Outcome Measures
Name Time Method SD: standard deviation of glycemia calculated during the 5 first days after beginning of insulin infusion LBGI: low blood glucose index calculated during the 5 first days after beginning of insulin infusion time before the first glucose value in the target range (h) calculated during the 5 first days after beginning of insulin infusion MAG: mean absolute glucose change calculated during the 5 first days after beginning of insulin infusion CV: coefficient of variation of glycemia calculated during the 5 first days after beginning of insulin infusion LI: lability index calculated during the 5 first days after beginning of insulin infusion HBGI: high blood glucose index calculated during the 5 first days after beginning of insulin infusion mean blood glucose calculated during the 5 first days after beginning of insulin infusion GRADE: glycemic risk assessment diabetes equation calculated during the 5 first days after beginning of insulin infusion time spent in the target range (140 to 180 mg/dL - 7.7 to 9.9 mmol/L) calculated during the 5 first days after beginning of insulin infusion low blood glucose episodes (less than 80 and 60 mg/dL - 4.4 and 3.3 mmol/L) (n/patient) measured during the 5 first days after beginning of insulin infusion M-Value calculated during the 5 first days after beginning of insulin infusion severe hypoglycemia (less than 40 mg/dL - 2.2 mmol/L) (n/patient) measured during the 5 first days after beginning of insulin infusion