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Completed

NCT Number: NCT02847104

Medical ICU Paper-based Dynamic Insulin Protocol

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

dynamic insulin protocol

Other

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

static insulin protocol

Other

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

Primary outcomes

  1. MAGE (mean amplitude of glycemic excursion) index

    Time frame: calculated during the 5 first days after beginning of insulin infusion

Secondary outcomes

  1. MAG: mean absolute glucose change

    Time frame: calculated during the 5 first days after beginning of insulin infusion

  2. LI: lability index

    Time frame: calculated during the 5 first days after beginning of insulin infusion

  3. SD: standard deviation of glycemia

    Time frame: calculated during the 5 first days after beginning of insulin infusion

  4. CV: coefficient of variation of glycemia

    Time frame: calculated during the 5 first days after beginning of insulin infusion

  5. LBGI: low blood glucose index

    Time frame: calculated during the 5 first days after beginning of insulin infusion

  6. HBGI: high blood glucose index

    Time frame: calculated during the 5 first days after beginning of insulin infusion

  7. GRADE: glycemic risk assessment diabetes equation

    Time frame: calculated during the 5 first days after beginning of insulin infusion

  8. M-Value

    Time frame: calculated during the 5 first days after beginning of insulin infusion

  9. mean blood glucose

    Time frame: calculated during the 5 first days after beginning of insulin infusion

  10. time spent in the target range (140 to 180 mg/dL - 7.7 to 9.9 mmol/L)

    Time frame: calculated during the 5 first days after beginning of insulin infusion

  11. low blood glucose episodes (less than 80 and 60 mg/dL - 4.4 and 3.3 mmol/L) (n/patient)

    Time frame: measured during the 5 first days after beginning of insulin infusion

  12. severe hypoglycemia (less than 40 mg/dL - 2.2 mmol/L) (n/patient)

    Time frame: measured during the 5 first days after beginning of insulin infusion

  13. time before the first glucose value in the target range (h)

    Time frame: calculated during the 5 first days after beginning of insulin infusion

Sponsors and collaborators

Lead sponsor

University Hospital, Caen

Other

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jul 28, 2016
Registry last updated
Jul 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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