Perioperative Insulin, GIK or GLP-1 Treatment in Diabetes Mellitus (PILGRIM)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor:
Information provided by (Responsible Party):
B Preckel, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier:
NCT02036372
First received: January 10, 2014
Last updated: May 13, 2014
Last verified: May 2014

January 10, 2014
May 13, 2014
January 2014
December 2015   (final data collection date for primary outcome measure)
Median glucose [ Time Frame: 1 hour after surgery ] [ Designated as safety issue: No ]
The difference in median glucose between the GIK, BR and LG group 1 hour after surgery
Same as current
Complete list of historical versions of study NCT02036372 on ClinicalTrials.gov Archive Site
  • Total Insulin administration [ Time Frame: 1 day postoperative ] [ Designated as safety issue: No ]
    The difference in insulin administration between the GIK, BR and LG group within 24 h after start of surgery
  • Median glucose [ Time Frame: 4 hours and 1 day postoperative ] [ Designated as safety issue: No ]
    The difference in median glucose between the GIK, BR and LG group 4 hours and 1 day after surgery
  • Postoperative complications [ Time Frame: 1 month after surgery ] [ Designated as safety issue: No ]
    The difference in proportion of any postoperative complication within the first month
  • Hypoglycemia [ Time Frame: From start treatment until the morning of day 1 postoperative ] [ Designated as safety issue: Yes ]
    The occurrence of mild and severe hypoglycemia (glucose <4.0 mmol/l and <2.3 mmol/l, respectively) during and up to 24 h after surgery
  • Hypo- and hyperkalemia [ Time Frame: from start treatment until morning of day 1 postoperative ] [ Designated as safety issue: Yes ]
    The occurrence of hypokalemia (<3.5 mmol/l) and hyperkalemia (>5.0 mmol/l) during and up to 24 h after surgery
Same as current
Not Provided
Not Provided
 
Perioperative Insulin, GIK or GLP-1 Treatment in Diabetes Mellitus
PILGRIM - Perioperative Insulin, GIK or GLP-1 Treatment in Diabetes Mellitus Type II

The incidence of diabetes mellitus type II is increasing. More and more patients who need surgery have diabetes mellitus type II. Despite an enormous amount of glucose lowering protocols and the proven negative effects of hyperglycaemia. There is no evidence for the optimal glucose lowering protocol.

This study investigates the optimal intraoperative treatment algorithm to lower glucose in patients with diabetes mellitus type 2 undergoing non-cardiac surgery, comparing intraoperative glucose-insulin-potassium infusion (GIK), insulin bolus regimen (BR) and GLP-1 (liraglutide, LG) treatment.

Diabetes mellitus is associated with poor outcome after surgery. The prevalence of diabetes in hospitalised patients is up to 40%, meaning that the anaesthesiologist will encounter a diabetes patient in the operating room on a daily basis. Multiple protocols for perioperative glucose regulation have been developed, ranging from intravenous glucose-insulin-potassium infusion to subcutaneous bolus regimens. Despite this abundance of published glucose lowering protocols and the proven negative effects of intraoperative hyperglycaemia in diabetes, there is no evidence regarding the optimal intraoperative glucose lowering treatment. 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 low incidence of hypoglycaemia. This study investigates for the first time the optimal intraoperative treatment algorithm to lower glucose in patients with diabetes mellitus undergoing non-cardiac surgery.

Objective:

This study investigates the optimal intraoperative treatment algorithm to lower glucose in patients with diabetes mellitus type 2 undergoing non-cardiac surgery, comparing intraoperative glucose-insulin-potassium infusion (GIK), insulin bolus regimen (BR) and GLP-1 (liraglutide, LG) treatment.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Diabetes Mellitus Type II
  • Drug: Liraglutide
    Other Name: Victoza
  • Drug: Insulin bolus
    Other Name: novorapid
  • Drug: GIK infusion
    continuous infusion
    Other Name: glucose, insulin, potassium infusion
  • Experimental: BR (bolus regimen)
    • Day before surgery: half evening dose long acting insulin
    • Day of surgery:

      • patients using mealtime and longacting insulin/NPH: withhold mealtime morning dose, stop glucose lowering tablets
      • patients using only long acting insulin/NPH: half dose of long-acting or NPH insulin, stop glucose lowering tablets
    • Measure blood glucose every 60 minutes, start 30 min prior to surgery
    • Give bolus of insulin according to treatment algorithm
    Intervention: Drug: Insulin bolus
  • Experimental: LG (Liraglutide)
    • Day before surgery: half dose of long acting and mealtime insulin from start liraglutide
    • Day of surgery: withhold own insulin, stop oral glucose lowering tablets
    • Start with 0.6 mg liraglutide subcutaneously (s.c.) the day prior to surgery at 17.00hr.
    • In case of nausea graded higher than minimal, the patient will be excluded from the study
    • Otherwise, treatment will be continued with 1.2 mg liraglutide s.c. per day on the day of surgery at 07.00hr.
    • Measure glucose every 60 minutes, start 30 min prior to surgery
    • Adjust according to bolus algorithm of BR group
    Interventions:
    • Drug: Liraglutide
    • Drug: Insulin bolus
  • Active Comparator: GIK (glucose -insulin - potassium) infusion
    • Day before surgery: half evening dose long acting insulin
    • Day of surgery: stop oral glucose lowering tablets and withhold own insulin.
    • GIK infusion: 500 cc glucose 5% with insulin and 10 mmol KCL per 500 cc. Start at 83 ml/hr.
    • Calculate the insulin amount in the GIK infusion according to the formula:

    I= (PG-7)/(200/W)+8 I=Insulin amount, PG=glucose 30 minutes preoperative, W= body weight in kg

    • Measure blood glucose every 60 minutes, start 30 min prior to surgery
    • Adjust glucose > 8 mmol/l according to treatment algorithm
    Intervention: Drug: GIK infusion
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
315
March 2016
December 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Signed informed consent
  • known diabetes mellitus type II for > 3 months
  • aged 18-75 years
  • scheduled for elective non-cardiac surgery
  • daily insulin dosage of < 0.5IU/kg body weight

Exclusion Criteria:

  • Oral corticosteroid use
  • Planned for day-care (ambulant) surgery
  • Planned ICU stay post-operatively
  • Planned bowel surgery
  • History of chronic pancreatitis or idiopathic acute pancreatitis
  • Impaired liver function, defined as alanine aminotransferase (ALAT) ≥ 2.5 times upper normal limit
  • Impaired renal function defined as serum-creatinine ≥ 133 μmol/L for males and ≥ 115 μmol/L for females
  • Females of child bearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods (adequate contraceptive measures as required by local law or practice)
  • Known or suspected allergy to trial product(s) or related products
  • Any condition that the local investigator feels would interfere with trial participation or the evaluation of results
Both
18 Years to 75 Years
No
Contact: Jorinde AW Polderman, MD +31205669111 ext 57431 j.a.polderman@amc.uva.nl
Contact: Jeroen Hermanides, MD, PhD +31205669111 j.hermanides@amc.uva.nl
Netherlands
 
NCT02036372
NL 41467.018.12
Yes
B Preckel, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Not Provided
Principal Investigator: Benedikt Preckel, MD, PhD Academic Medical Centre - AMC-UvA
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP