Medical ICU Paper-based Dynamic Insulin Protocol

Stress Hyperglycemia Clinical Trial

Official title:

Impact of a Paper-based Dynamic Insulin Infusion Protocol on Glycemic Variability, Time in Target and Hypoglycemic Risk: a Stepped Wedge Trial in Medical ICU Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02847104
• Other study ID #: VARIREA
• Status: Completed
• Phase: N/A
• First received: July 25, 2016
• Last updated: July 27, 2016
• Start date: February 2013
• Est. completion date: June 2014

Study information

• Verified date: July 2016
• Source: University Hospital, Caen
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santéFrance: Commission nationale de l'informatique et des libertés
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 131
• Est. completion date: June 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Previous diabetes

• Acute metabolic event (ketoacidosis or hyperosmolarity)

• Insulin/dextrose infusion for hyperkalemia treatment

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Hyperglycemia
• Stress Hyperglycemia

Intervention

Other:
• dynamic insulin protocol
Adaptation of insulin infusion rate according to hourly capillary blood glucose and dynamic insulin protocol
• static insulin protocol
Adaptation of insulin infusion rate according to hourly capillary blood glucose and static insulin protocol

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MAGE (mean amplitude of glycemic excursion) index		calculated during the 5 first days after beginning of insulin infusion	No
Secondary	MAG: mean absolute glucose change		calculated during the 5 first days after beginning of insulin infusion	No
Secondary	LI: lability index		calculated during the 5 first days after beginning of insulin infusion	No
Secondary	SD: standard deviation of glycemia		calculated during the 5 first days after beginning of insulin infusion	No
Secondary	CV: coefficient of variation of glycemia		calculated during the 5 first days after beginning of insulin infusion	No
Secondary	LBGI: low blood glucose index		calculated during the 5 first days after beginning of insulin infusion	No
Secondary	HBGI: high blood glucose index		calculated during the 5 first days after beginning of insulin infusion	No
Secondary	GRADE: glycemic risk assessment diabetes equation		calculated during the 5 first days after beginning of insulin infusion	No
Secondary	M-Value		calculated during the 5 first days after beginning of insulin infusion	No
Secondary	mean blood glucose		calculated during the 5 first days after beginning of insulin infusion	No
Secondary	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	No
Secondary	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	Yes
Secondary	severe hypoglycemia (less than 40 mg/dL - 2.2 mmol/L) (n/patient)		measured during the 5 first days after beginning of insulin infusion	Yes
Secondary	time before the first glucose value in the target range (h)		calculated during the 5 first days after beginning of insulin infusion	No