Comparing glucose control in the critically ill patient through two methods - conventional insulin sliding scale as compared to computerised automated insulin delivery ( enhanced model predictive control).
Efficacy of enhanced model predictive control (eMPC) in insulin therapy in the critically ill
University Malaya
60 participants
Apr 1, 2016
Interventional
Conditions
Summary
In the pathophysiology of sepsis, pro-inflammatory cytokines including IL-6, IL-1, TNFa are known to play a pivotal role, and an overproduced cytokines enter into the bloodstream causing hypercytokinaemia, which leads to organ failure via humoral mediator network activation and vascular endothelial damage. This overwhelming production of mediators such as pro- and anti-inflammatory cytokines can cause different kinds of metabolic derangements such as hyperglycemia. Hyperglycemia in the hospital, whether in patients with known diabetes or with a temporary hyperglycaemic state due to stress, is known to be associated with poor outcome such as prolonged hospitalization, increased rates of infection, and in-hospital death. In the years 2001, 2006 and 2009, three large randomized controlled single centre trials in three different intensive care departments have shown that normalized glucose level would lead to a significant reduction of in-hospital mortality and morbidity. Insulin Therapy (IT) has been characterized as an important treatment option to substantially improve outcome in medical and surgical patients in adult ICUs. The blood sugar management has been a challenging, complex and time consuming task that requires nurses with enough experience and knowledge. The common method was based on a paper based protocol for manual intensive insulin therapy, which is-Sliding scales. Often, the required dosage of insulin is estimated rather than determined according to objective criteria. Therefore, lethal consequences, in the form of hypoglycaemia, can occur due to false estimations under certain circumstances. eMPC (enhanced model predictive control) is a computer-based decision support system which helps to achieve accurate and reliable blood glucose control in the desired ranges. Information on parenteral and enteral nutrition is automatically integrated in the calculations. The algorithm may help to overcome some of the limitations in current practice by aiding physicians in the decision making process. The eMPC (enhanced model predictive control) algorithm has been successfully tested in several clinical trials involved more than 200 patients. We thus aim to undertake a prospective, randomized, open label single-center study to investigate the effectiveness of the eMPC algorithm in local adult medical ICU patients. The correlation between blood IL-6 level and blood glucose control in patients with sepsis will also be investigated.
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Interventions
This is a randomised controlled trial. The objective of this trial is to compare the efficacy between the delivery of insulin via the eMPC model (through a Space Glucose Device) and delivery of insulin via conventional infusion method with the usage of insulin sliding scale, in regards to glucose control. The Space GlucoseControl Device is a Class IIb medical device. It is a device manufactured by B Braun. The Space GlucoseControl device is a decision support system that calculates an optimum level of insulin dosing. It consists of 3 infusion pumps, 2 for enteral and parenteral nutrition, and 1 for insulin. The system automatically records information from the nutrition pumps including current status of infusion, bolus doses and carbohydrate intake. It combines this information with manually-entered blood glucose measurements, administered insulin doses and patient-specific data, such as previous response to insulin. A proprietary computer algorithm in the system, called the enhanced model predictive control (eMPC) algorithm, then predicts the future blood glucose curve and calculates the best insulin dose rate to keep blood glucose within the range sprecified by the clinician responsible for the patient's care. Based on the algorithm prediction, the Space GlucoseControl system calculates the time interval to the next blood glucose measurement and gives and audio-visual alarm to alert nursing staff when it is due. A total of 60 patients will be recruited for this trial. The patients recruited are critically ill adult patients with severe sepsis or septic shock; and with a blood glucose of more than 8.9mmol/l upon admission to ICU. The blood glucose target is aimed to be 5.5-8.9mmol/l.. Patients recruited for the trial will be radomised into two groups. The first group will have insulin delivered via the Space ClucoseControl Device (which uses the eMPC algorithm). Upon commencement of the insulin therapy, baseline blood glucose will be measured and recorded, with the insulin infusion commenced at the rate recommended by the device. Based on the eMPC algorithm prediction, the device calculates the time interval to the next blood glucose measurement and alerts the nursing staff to check the blood glucose level and adjust the insulin delivery accordingly. The time interval for blood sampling ranges from 30minutes to 4 hours depending on the algorithm. If patient is started on enteral and parenteral nutrition, the date is also entered into the device and adjustments in delivery would be made after calculations are made based on the algorithm. All trial related activities and data will be carried out until the completion of 5 days. After 5 days, if patient still requires insulin therapy, they would be switched to conventional insulin infusion with Insulin Sliding Scale. The second group of patients will be randomized into the group with insulin delivery via conventional method, with the aid of Insulin Sliding Scale. The rate of infusion of insulin would be determined by the scale. Monitoring of blood glucose would be hourly upon commencement, and the interval would be increased to 2-4hours (when there is no rate change in 2 consecutive hours), and adjustments for the infusion rate is made manually, and according to the Insulin Sliding Scale selected. All trial related activities and data will be collected for 5 days. Upon completion of 5 days, if patient still requires insulin infusion, it would still be continued for the patient.
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ACTRN12616001450404