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




Study protocol of a randomised controlled trial comparing perioperative intravenous insulin, GIK or GLP-1 treatment in diabetes–PILGRIM trial - Download this document for free, or read online. Document in PDF available to download.

BMC Anesthesiology

, 14:91

Perioperative medicine and outcome

Abstract

BackgroundDiabetes mellitus DM is associated with poor outcome after surgery. The prevalence of DM in hospitalised patients is up to 40%, meaning that the anaesthesiologist will encounter a patient with DM in the operating room on a daily basis. Despite an abundance of published glucose lowering protocols and the known negative outcomes associated with perioperative hyperglycaemia in DM, there is no evidence regarding the optimal intraoperative glucose lowering treatment. In addition, protocol adherence is usually low and protocol targets are not simply met.

Recently, incretins have been introduced to lower blood glucose. The main hormone of the incretin system is glucagon-like peptide–1 GLP-1. GLP-1 increases insulin and decreases glucagon secretion in a glucose-dependent manner, resulting in glucose lowering action with a low incidence of hypoglycaemia.

We set out to determine the optimal intraoperative treatment algorithm to lower glucose in patients with DM type 2 undergoing non-cardiac surgery, comparing intraoperative glucose-insulin-potassium infusion GIK, insulin bolus regimen BR and GPL-1 liragludite, LG treatment.

Methods-DesignThis is a multicentre randomised open label trial in patients with DM type 2 undergoing non-cardiac surgery. Patients are randomly assigned to one of three study arms; intraoperative glucose-insulin-potassium infusion GIK, intraoperative sliding-scale insulin boluses BR or GPL-1 pre-treatment with liraglutide LG. Capillary glucose will be measured every hour. If necessary, in all study arms glucose will be adjusted with an intravenous bolus of insulin. Researchers, care givers and patients will not be blinded for the assigned treatment. The main outcome measure is the difference in median glucose between the three study arms at 1 hour postoperatively. We will include 315 patients, which gives us a 90% power to detect a 1 mmol l difference in glucose between the study arms.

DiscussionThe PILGRIM trial started in January 2014 and will provide relevant information on the perioperative use of GLP-1 agonists and the optimal intraoperative treatment algorithm in patients with diabetes mellitus type 2.

Trial registrationClinicalTrials.gov, NCT02036372

KeywordsDiabetes mellitus type 2 Perioperative management GLP-1 agonist AbbreviationsDMDiabetes mellitus

GIKGlucose-insulin-potassium

BRBolus regime

LGLiraglutide

GLP-1Glucagon like peptide-1

ICUIntensive care unit

CRFCase report form

NPHNeutral protamine Hagedorn

OROdds ratio

HRHazard ratio

CIConfidence interval.

Electronic supplementary materialThe online version of this article doi:10.1186-1471-2253-14-91 contains supplementary material, which is available to authorized users.

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Author: Jorinde AW Polderman - Peter L Houweling - Markus W Hollmann - J Hans DeVries - Benedikt Preckel - Jeroen Hermanides

Source: https://link.springer.com/







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