Study protocol of a randomised controlled trial comparing perioperative intravenous insulin, GIK or GLP-1 treatment in diabetes–PILGRIM trial

Polderman, J; Houweling, P. L.; Hollmann, Markus W.; DeVries, J. Hans; Preckel, Benedikt; Hermanides, Jeroen

doi:10.1186/1471-2253-14-91

Cited by 7 publications

(7 citation statements)

References 32 publications

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“…A detailed description of the protocol of this study was published at the start of the trial . In summary, we conducted a multi‐centre open‐label randomised controlled trial, that studied patients with type‐2 diabetes mellitus, aged 18–75 years, who were scheduled for non‐cardiac inpatient surgery.…”

Section: Methodsmentioning

confidence: 99%

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Peri‐operative management of patients with type‐2 diabetes mellitus undergoing non‐cardiac surgery using liraglutide, glucose–insulin–potassium infusion or intravenous insulin bolus regimens: a randomised controlled trial

et al. 2017

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In this open-label multicentre randomised controlled trial, we investigated three peri-operative treatment strategies to lower glucose and reduce the need for rescue insulin in patients aged 18-75 years with type-2 diabetes mellitus undergoing non-cardiac surgery. Patients were randomly allocated using a web-based randomisation program to premedication with liraglutide (liraglutide group), glucose-insulin-potassium infusion (insulin infusion group) or insulin bolus regimen (insulin bolus group), targeting a glucose < 8.0 mmol.l . The primary outcome was the between group difference in median glucose levels 1 h after surgery. We analysed 150 patients (liraglutide group n = 44, insulin infusion group n = 53, insulin bolus group n = 53) according to the intention-to-treat principle. Median (IQR [range]) plasma glucose 1 h postoperatively was lower in the liraglutide group compared with the insulin infusion and insulin bolus groups (6.6 (5.6-7.7 [4.2-13.5]) mmol.l vs. 7.5 (6.4-8.3 [3.9-16.6]) mmol.l (p = 0.026) and 7.6 (6.4-8.9 [4.7-13.2]) mmol.l ) p = 0.006, respectively). The incidence of hypoglycaemia and postoperative complications did not differ between the groups. Six patients had pre-operative nausea in the liraglutide group, of which two had severe nausea, compared with no patients in the insulin infusion and insulin bolus groups (p = 0.007). The pre-operative administration of liraglutide stabilised peri-operative plasma glucose levels and reduced peri-operative insulin requirements, at the expense of increased pre-operative nausea rates.

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Section: Methodsmentioning

confidence: 99%

“…When plasma glucose was > 8.0 mmol.l −1 a bolus of i.v. insulin was administered according to the study algorithm . The anaesthetic team was instructed not to use dexamethasone for postoperative nausea and vomiting (PONV) prophylaxis.…”

Section: Methodsmentioning

confidence: 99%

Peri‐operative management of patients with type‐2 diabetes mellitus undergoing non‐cardiac surgery using liraglutide, glucose–insulin–potassium infusion or intravenous insulin bolus regimens: a randomised controlled trial

et al. 2017

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“…[ 16 ] Liraglutide is being studied in a multicenter trial for the control of perioperative hyperglycemia and has recently been shown to prevent the cardiovascular mortality in T2DM. [ 10 17 ] A recent report showed similar benefit using sitagliptin (Incretin enhancer) along with basal insulin. [ 18 ] The benefits of liraglutide in critical care settings extend beyond the obvious glycemic control.…”

Section: Discussionmentioning

confidence: 99%

Liraglutide as an alternative to insulin for glycemic control in intensive care unit: A randomized, open-label, clinical study

Verma

Kotwal

Upreti

et al. 2017

Indian Journal of Critical Care Medicine

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Background:Intravenous insulin is the cornerstone in the management of hyperglycemia in the Intensive Care Unit (ICU). We studied the efficacy of liraglutide compared with insulin in the ICU.Materials and Methods:In this prospective, open-labeled, randomized study, we included 120 patients (15–65 years, either sex) admitted to ICU with capillary blood glucose (CBG) between 181 and 300 mg/dl. We excluded patients with secondary diabetes and APACHE score >24. The patients were divided into two groups (n = 60) based on the CBG: Group 1 (181–240) and Group 2 (241–300). They were randomized further into four subgroups (n = 30) to receive insulin (Groups 1A and 2A), liraglutide (Group 1B), and insulin with liraglutide (Group 2B). The primary outcome was the ability to achieve CBG below 180 mg/dL at the end of 24 h. The secondary outcomes include mortality at 1 month and hospital stay. Data and results were analyzed using Mann-Whitney U-test, paired t- test, and Chi-square tests.Results:The mean age of the patients (93M and 27F) was 57.1 ± 13.9 years, hospital stay (16.9 ± 7.5 days), and CBG was 240.5 ± 36.2 mg/dl. The primary outcome was reached in 26, 27, 25, and 28 patients of Groups 1A, 2A, 1B, and 2B, respectively. The 30-day mortality and hospital stay were similar across all the four groups. Hypoglycemia was common with insulin and gastrointestinal side effects were more common with liraglutide (P < 0.001).Conclusion:Liraglutide is a viable alternative to insulin for glycemic control in the ICU. Further studies with a larger number of patients are required to confirm our findings.

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“…For the patients in group bolus, intravenous insulin -Monocomponent Human Insulin, biosynthetic r-DNA origin -Human Actrapid® (manufactured by Torrent Pharmaceuticals Ltd, Indrad 382 721, Dist: Mehsana, India, under license from Novo Nordisk India Private Ltd. Whitefield, Bangalore) was administered as given in Table 1. 7 This regimen was adapted from a trial published by Poldermann et al, converting mmol/L to mg/dL using multiplication factor 18 for conversion of mmol/L to mg/dL (1mmol/L = 18 mg/dL), since the common mode of blood glucose measurement in our practice is in mg/dL. 7 In an event of hypoglycaemia (blood glucose level < 70 mg/dL), treatment was provided as bolus 100ml 5% dextrose in water (D5W) rapidly followed by repeat blood sugar level after 15mins.…”

Section: Interventionsmentioning

confidence: 99%

“…Intravenous insulin bolus is simple and reliable method for intra-operative glycaemic control and has been described by Poldermann et al 7 Intravenous insulin infusion along with glucose is another popular regimen for intra-operative blood glucose management. 8 We compared the intra-operative glycaemic levels between insulin bolus regimen and glucose insulin infusion regimen.…”

Section: Introductionmentioning

confidence: 99%

Comparative study between insulin bolus regimen and glucose insulin infusion regimen on effectiveness of intraoperative blood glucose control in patients with type 2 diabetes mellitus undergoing non-cardiac surgery

Arun

Krishna

2019

Sri Lankan J Anaesthesiol

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Background: The surgical rates are comparatively greater among diabetic patients. Surgery, a period of stress, mandates fasting and anti-diabetic medications are skipped on the morning of the procedure. High blood glucose levels in the peri-operative period can lead to ischaemia, infection, acute kidney injury and electrolyte disturbances. Hence, control of blood glucose levels during the peri-operative period becomes important and there are various regimens described. We compared two of the existing regimens, intravenous insulin bolus and glucose insulin infusion regimen, for their effectiveness of intraoperative blood glucose control. Method: In this randomized, prospective controlled study, 120 patients were enrolled with 60 patients in bolus group and 60 in infusion group. Capillary blood glucose was measured every hour during the intra-operative period. The primary outcome measure was proportion of patients in the target glucose levels between 100 mg/dL and 180 mg/dL and proportion of intra-operative surgery time (in minutes) during which patient was in the target range. Secondary outcome measure was serum potassium levels pre-operatively and postoperatively. Results: The proportion of patients in the target range in the bolus group was 39 out of 60 as compared to 31 out of 60 in the infusion group (P=0.13). Also, proportion of intraoperative surgery time (in minutes) during which patient was in the target glycaemic range was 41.57% in bolus group when compared to 27.22% in the infusion group (P < 0.05). No hypoglycaemic episodes were seen in any of the patients in the two groups. Conclusion: As compared with infusion regimen, bolus regimen provides better glycaemic control measured in terms of target blood glucose levels and duration for which the patient remained in the target range.

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Study protocol of a randomised controlled trial comparing perioperative intravenous insulin, GIK or GLP-1 treatment in diabetes–PILGRIM trial

Cited by 7 publications

References 32 publications

Peri‐operative management of patients with type‐2 diabetes mellitus undergoing non‐cardiac surgery using liraglutide, glucose–insulin–potassium infusion or intravenous insulin bolus regimens: a randomised controlled trial

Peri‐operative management of patients with type‐2 diabetes mellitus undergoing non‐cardiac surgery using liraglutide, glucose–insulin–potassium infusion or intravenous insulin bolus regimens: a randomised controlled trial

Liraglutide as an alternative to insulin for glycemic control in intensive care unit: A randomized, open-label, clinical study

Comparative study between insulin bolus regimen and glucose insulin infusion regimen on effectiveness of intraoperative blood glucose control in patients with type 2 diabetes mellitus undergoing non-cardiac surgery

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