Medical ICU Paper-based Dynamic Insulin Protocol

NCT02847104 | Completed

• 1 other identifier: VARIREA
• Study Type: observational
• Target: 131
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Stress Hyperglycemia

Outcome Measures

Primary Outcomes (1)

• MAGE (mean amplitude of glycemic excursion) index

  calculated during the 5 first days after beginning of insulin infusion

Secondary Outcomes (13)

• MAG: mean absolute glucose change

  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

• SD: standard deviation of glycemia

  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

• LBGI: low blood glucose index

  calculated during the 5 first days after beginning of insulin infusion

Study Arms (2)

dynamic insulin protocol

patients received intravenous insulin infusion according to a dynamic insulin protocol

Other: dynamic insulin protocol

static insulin protocol

patients received intravenous insulin infusion according to a static insulin protocol

Other: static insulin protocol

Interventions

dynamic insulin protocol OTHER

Adaptation of insulin infusion rate according to hourly capillary blood glucose and dynamic insulin protocol

dynamic insulin protocol

static insulin protocol OTHER

Adaptation of insulin infusion rate according to hourly capillary blood glucose and static insulin protocol

static insulin protocol

Eligibility Criteria

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

Study Population

This prospective trial involved adult patients who were admitted to the medical intensive care department of a French university hospital to compare the effects of two continuous intravenous insulin infusion (CIII) protocols on glycemic variability. According to the local protocol, patients with two consecutive capillary blood glucose measurements greater than 180 mg/dL (9.9 mmol/L), one hour apart, were considered to require CIII and were included in the trial. All of the patients or their family members received written information about the trial.

You may qualify if:

• 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

You may not qualify if:

• Previous diabetes
• Acute metabolic event (ketoacidosis or hyperosmolarity)
• Insulin/dextrose infusion for hyperkalemia treatment

Sponsors & Collaborators

• University Hospital, Caen: lead

Study Officials

• damien du cheyron, PhD

  University Hospital, Caen

  STUDY CHAIR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2016
• First Posted: July 28, 2016
• Study Start: February 1, 2013
• Primary Completion: February 1, 2014
• Study Completion: June 1, 2014
• Last Updated: July 28, 2016

Record last verified: 2016-07