TY - JOUR
T1 - Study protocol of the randomised placebo-controlled GLOBE trial: GL P-1 f o r b ridging of hyperglyca e mia during cardiac surgery
AU - Hulst, Abraham H.
AU - Visscher, Maarten J.
AU - Godfried, Marc B.
AU - Thiel, Bram
AU - Gerritse, Bas M.
AU - Scohy, Thierry V.
AU - Bouwman, R. Arthur
AU - Willemsen, Mark G. A.
AU - Hollmann, Markus W.
AU - Devries, J. Hans
AU - Preckel, Benedikt
AU - Hermanides, Jeroen
PY - 2018
Y1 - 2018
N2 - Introduction Perioperative hyperglycaemia is common during cardiac surgery and associated with postoperative complications. Although intensive insulin therapy for glycaemic control can reduce complications, it carries the risk of hypoglycaemia. GLP-1 therapy has the potential to lower glucose without causing hypoglycaemia. We hypothesise that preoperative liraglutide (a synthetic GLP-1 analogue) will reduce the number of patients requiring insulin to achieve glucose values<8 mmol l -1 in the intraoperative period. Methods and analysis We designed a multi-centre randomised parallel placebo-controlled trial and aim to include 274 patients undergoing cardiac surgery, aged 18-80 years, with or without diabetes mellitus. Patients will receive 0.6 mg liraglutide or placebo on the evening before, and 1.2 mg liraglutide or placebo just prior to surgery. Blood glucose is measured hourly and controlled with an insulin bolus algorithm, with a glycaemic target between 4-8 mmol l â -1. The primary outcome is the percentage of patients requiring insulin intraoperatively. Ethics and dissemination This study protocol has been approved by the medical ethics committee of the Academic Medical Centre (AMC) in Amsterdam and by the Dutch competent authority. The study is investigator-initiated and the AMC, as sponsor, will remain owner of all data and have all publication rights. Results will be submitted for publication in a peer-reviewed international medical journal. Trial registration number NTR6323; Pre-results.
AB - Introduction Perioperative hyperglycaemia is common during cardiac surgery and associated with postoperative complications. Although intensive insulin therapy for glycaemic control can reduce complications, it carries the risk of hypoglycaemia. GLP-1 therapy has the potential to lower glucose without causing hypoglycaemia. We hypothesise that preoperative liraglutide (a synthetic GLP-1 analogue) will reduce the number of patients requiring insulin to achieve glucose values<8 mmol l -1 in the intraoperative period. Methods and analysis We designed a multi-centre randomised parallel placebo-controlled trial and aim to include 274 patients undergoing cardiac surgery, aged 18-80 years, with or without diabetes mellitus. Patients will receive 0.6 mg liraglutide or placebo on the evening before, and 1.2 mg liraglutide or placebo just prior to surgery. Blood glucose is measured hourly and controlled with an insulin bolus algorithm, with a glycaemic target between 4-8 mmol l â -1. The primary outcome is the percentage of patients requiring insulin intraoperatively. Ethics and dissemination This study protocol has been approved by the medical ethics committee of the Academic Medical Centre (AMC) in Amsterdam and by the Dutch competent authority. The study is investigator-initiated and the AMC, as sponsor, will remain owner of all data and have all publication rights. Results will be submitted for publication in a peer-reviewed international medical journal. Trial registration number NTR6323; Pre-results.
UR - https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=85053159902&origin=inward
UR - https://www.ncbi.nlm.nih.gov/pubmed/29866735
U2 - https://doi.org/10.1136/bmjopen-2018-022189
DO - https://doi.org/10.1136/bmjopen-2018-022189
M3 - Article
C2 - 29866735
SN - 2044-6055
VL - 8
JO - BMJ Open
JF - BMJ Open
IS - 6
M1 - e022189
ER -