High Dose Insulin for Surgical Site Infections
Recruiting in Palo Alto (17 mi)
+2 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Disqualifiers: Diabetes, Hypertension, Bipolar, others
Trial Summary
What is the purpose of this trial?
Despite improvements in surgical techniques and perioperative care, the high incidence of postoperative surgical site infections remains a major problem in patients undergoing major abdominal surgery (liver, pancreatic and colorectal surgery). Using the hyperinsulinemic-normoglycemic clamp technique, i.e. continuous infusion of insulin combined with dextrose titrated to "clamp" blood glucose between 4 and 6 mmol/L, we successfully established and preserved normoglycemia during the perioperative period. Our objective of this study is to determine if the maintenance of perioperative normoglycemia by a hyperinsulinemic normoglycemic clamp reduces the rates of incisional and space/ surgical site infections following abdominal surgery (liver, pancreatic and colorectal surgery).
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment Hyperinsulinemic normoglycemic clamp for surgical site infections?
Is high-dose insulin therapy generally safe for humans?
How does the treatment 'High Dose Insulin for Surgical Site Infections' differ from other treatments for this condition?
This treatment uses a method called the hyperinsulinemic normoglycemic clamp, which involves giving high doses of insulin to maintain normal blood sugar levels, potentially reducing the risk of infections after surgery. Unlike standard treatments that may only address high blood sugar when it becomes very elevated, this approach aims for tight control of blood sugar levels to prevent complications.7891011
Eligibility Criteria
This trial is for adults who are scheduled for elective liver, pancreatic, or colorectal surgery and can give informed consent. It aims to see if managing blood sugar with high-dose insulin during and after surgery can reduce infections at the surgical site.Inclusion Criteria
I am scheduled for surgery on my liver, pancreas, or colon.
I understand the details of the clinical trial and can consent to participate.
I am 18 years old or older.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
1-2 weeks
1 visit (in-person)
Treatment
Participants undergo major abdominal surgery with either standard glucose management or hyperinsulinemic normoglycemic clamp technique
Perioperative period
In-hospital stay
Follow-up
Participants are monitored for surgical site infections and surgical morbidity for 30 days post-surgery
30 days
Regular follow-up visits
Treatment Details
Interventions
- Hyperinsulinemic normoglycemic clamp (Other)
- Standard glucose management (Other)
Trial OverviewThe study compares standard glucose management to a technique called hyperinsulinemic normoglycemic clamp, which involves giving insulin and dextrose to maintain normal blood sugar levels during major abdominal surgery.
Participant Groups
2Treatment groups
Active Control
Placebo Group
Group I: Hyperinsulinemic normoglycemic clampActive Control1 Intervention
The blood glucose level will be checked prior to intubation. A 2U bolus of IV insulin will be given if blood glucose level is higher than 6 mmol/l, followed by an IV infusion of 2 U/kg/min (0.12 U/kg/hour). Dextrose 20% (D20W®) will be titrated to maintain blood glucose between 4 and 6 mmol/l. Blood glucose levels will be measured at 5-30 min intervals with a to ensure normoglycemia. At the end of surgery, the insulin infusion will be stopped, and the dextrose infusion weaned off in the post anesthesia care unit.
Group II: Standard glucose managementPlacebo Group1 Intervention
Arterial-blood glucose levels will be checked at induction of anesthesia and every 30 - 60 min thereafter with an StatStrip Xpress® (Nova Biomedical, MA, USA) ( A blood glucose level above 10 mmol/l will be treated with a 2U bolus of IV insulin (Humulin® R regular insulin, Eli Lilly and Company, Indianapolis, IN) followed by a 1 U/hour drip infusion adjusted according to a standard sliding scale
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Royal Victoria Hospital, McGill University Health CentreMontreal, Canada
Royal Victoria HospitalMontreal, Canada
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Who Is Running the Clinical Trial?
McGill University Health Centre/Research Institute of the McGill University Health CentreLead Sponsor
References
Glucose and insulin administration while maintaining normoglycemia during cardiac surgery using a computer-assisted algorithm. [2013]applying the principles of the hyperinsulinemic-normoglycemic clamp technique we have introduced glucose and insulin administration while maintaining normoglycemia (GIN therapy) to surgical patients. The objective of this study was to evaluate a novel computer software (GIN Computer Software [GINCS]) program using an algorithm based on the original clamp equation and modified for its use during cardiac surgery.
Perioperative tight glucose control with hyperinsulinemic-normoglycemic clamp technique in cardiac surgery. [2010]Previous attempts to achieve tight glucose control in surgical patients were associated with a significant incidence of hypoglycemia. The purpose of this study was to evaluate the efficacy of perioperative glucose and insulin administration while maintaining normoglycemia using a hyperinsulinemic-normoglycemic clamp technique.
Maintenance of normoglycemia during cardiac surgery. [2022]We used the hyperinsulinemic normoglycemic clamp technique, i.e., infusion of insulin at a constant rate combined with dextrose titrated to clamp blood glucose at a specific level, to preserve normoglycemia during elective cardiac surgery. Ten nondiabetic and seven diabetic patients entered the clamp protocols. Perioperative glucose control was also assessed in 19 nondiabetic and 11 diabetic patients (control group) receiving a conventional insulin infusion sliding scale. In patients of the clamp group, a priming bolus of insulin (2 U) was started before the induction of anesthesia followed by infusions of insulin at 5 mU. kg(-1). min(-1) and of variable amounts of dextrose. Arterial blood glucose was measured every 5 min in the clamp group and every 20 min in the control group. Control of normoglycemia was defined as > or =95% of the glucose levels within 4.0-6.0 mmol/L. Glucose concentration was recorded before surgery, 15 min before cardiopulmonary bypass (CPB), during early and late CPB, and at sternal closure. Patients of the control group became progressively hyperglycemic during surgery (late CPB; nondiabetics, 9.0 +/- 3.2 mmol/L; diabetics, 10.1 +/- 3.6 mmol/L), whereas normoglycemia was achieved in the study group (late CPB; nondiabetics, 5.5 +/- 0.7 mmol/L; diabetics, 4.9 +/- 0.6 mmol/L; P
Basal insulin, glucagon, and growth hormone replacement. [2016]Conclusions drawn from the pancreatic (or islet) clamp technique (suppression of endogenous insulin, glucagon, and growth hormone secretion with somatostatin and replacement of basal hormone levels by intravenous infusion) are critically dependent on the biological appropriateness of the selected doses of the replaced hormones. To assess the appropriateness of representative doses we infused saline alone, insulin (initially 0.20 mU.kg(-1).min(-1)) alone, glucagon (1.0 ng.kg(-1).min(-1)) alone, and growth hormone (3.0 ng.kg(-1).min(-1)) alone intravenously for 4 h in 13 healthy individuals. That dose of insulin raised plasma insulin concentrations approximately threefold, suppressed glucose production, and drove plasma glucose concentrations down to subphysiological levels (65 +/- 3 mg/dl, P
Impact of stress-induced diabetes on outcomes in severely burned children. [2021]Post-burn hyperglycemia leads to graft failure, multiple organ failure, and death. A hyperinsulinemic-euglycemic clamp is used to keep serum glucose between 60 and 110 mg/dL. Because of frequent hypoglycemic episodes, a less-stringent sliding scale insulin protocol is used to maintain serum glucose levels between 80 and 160 mg/dL after elevations >180 mg/dL.
Measurement of insulin absorption and insulin action. [2011]For the practical implementation of every type of insulin therapy it is necessary to know both the time course of action of therapeutically used short- and long-acting insulin preparations and the factors influencing such time-action profiles. The only reliable way to obtain the required quantitative information about the pharmacokinetic and glucodynamic properties of insulin preparations has been the use of the euglycemic glucose clamp technique. The first studies with each new insulin formulation or insulin application technique should be performed with healthy subjects in order to have the most comparable study conditions. Thereafter, results from such clinical-experimental studies should be verified in similar studies with patients with diabetes. Earlier investigational approaches, which either had been limited to the determination of the pharmacokinetic properties of insulin preparations or had used the quantitative decrease of the blood glucose level as a measure of the pharmacodynamic properties, do not provide valid quantitative results. The proposed glucose clamp technique makes possible the quantitative study of the pharmacokinetic and pharmacodynamic properties of insulin preparations under comparative and reproducible conditions.
Insulin strategies for managing inpatient and outpatient hyperglycemia and diabetes. [2011]Optimal fasting and postprandial glycemic control are essential to limiting microvascular and macrovascular complications associated with diabetes. Recently, stringent control of hyperglycemia in critically ill hospitalized patients with diabetes or acute hyperglycemia has been shown to reduce the risk of morbidity and mortality. This article reviews effective strategies for insulin initiation, titration, and intensification in inpatient and outpatient settings and discusses current treatment strategies when patients are being transitioned from the intensive care unit to general wards and discharged. The development of insulin analogs and premixed insulin analogs has created new options for treating inpatients and outpatients. The more physiologic time-action profiles, improved insulin delivery systems, and standardized protocols for subcutaneous insulin administration and intravenous insulin infusion have improved the safety and convenience of insulin therapy.
Glycemic control and prevention of surgical site infection. [2013]Stress hyperglycemia is associated with increased risk of surgical site infections (SSIs). Use of strict or tight glycemic control with intensive insulin therapy to prevent SSIs is controversial.
Insulin therapy for the critically ill patient. [2019]The risk of mortality or significant morbidity is high among critically ill patients who are treated in the intensive care unit (ICU) for > 5 days. These patients are susceptible to sepsis, excessive inflammation, critical illness polyneuropathy, and multiple organ failure, the latter often being the cause of death. Most intensive care patients, even those who did not previously suffer from diabetes, are hyperglycemic, which is presumed to reflect an adaptive development of insulin resistance. In the K.U. Leuven study it was hypothesized that hyperglycemia is not a beneficial adaptation to severe illness but rather predisposes patients to many of the typical intensive care complications--prolonged intensive care dependence and death. The effects of intensive insulin therapy to maintain normoglycemia during critical illness were studied in a large group (N = 1548) of ventilated, surgical ICU patients. An algorithm was proposed for implementing this procedure. The randomly assigned intensive insulin therapy group received insulin infusion tailored to control blood glucose (BG) levels in the range 80-110 mg/dL, whereas the conventional treatment group received insulin only when glucose levels exceeded 200 mg/dL, and in that event were maintained in a target range of 180-200 mg/dL. Intensive insulin therapy induced a 43% reduction of intensive care mortality risk (P = 0.036 after correction for interim analyses) and a 34% reduction of hospital mortality (P = 0.005). A reduced risk of severe infections by 46% (P = 0.003) was associated with a 35% reduction in prolonged (> 10 d) requirement for antibiotic therapy (P
Use of Insulin in the Inpatient Setting: Need for Continued Use. [2020]Insulin has been the standard of care for the management of inpatient diabetes for achieving strict glycemic control. This review supports continuing insulin therapy for hyperglycemic management in the hospital compared with the use of non-insulin treatment regimens.
Increased insulin requirements are associated with pneumonia after severe injury. [2015]Hyperglycemia after severe injury has been associated with an increased risk of infection and death. Strict glycemic control has been found to be valuable in select surgical populations. Varying amounts of insulin by infusion are required to maintain blood glucose levels within normal limits. Little is known about how insulin requirements are affected by the presence of infection, and therefore, the purpose of this study was to characterize this relationship.