E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
The objective of this study is to investigate whether a targeted preoperative glucose control before planned cardiac surgery by i.v. insulin infusion (intensified glycemic control, ICG) versus standard care improves postoperative outcome in patients with T2DM. In addition to evaluating involved molecular mechanisms, this study should also strengthen the evidence of guidelines regarding perioperative glucose management of patients with T2DM. |
|
E.1.1.1 | Medical condition in easily understood language |
to investigate whether a targeted glucose control before planned cardiac surgery by insulin infusion versus standard care improves outcome after surgery in patients with Diabetes mellitus type 2. |
|
E.1.1.2 | Therapeutic area | Body processes [G] - Metabolic Phenomena [G03] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Is it possible and safe to achieve a preoperative target blood glucose level between 100 and 180 mg/dl with an IGC in patients with T2DM with severe planned cardiovascular surgery? |
|
E.2.2 | Secondary objectives of the trial |
o The rate of preoperative hypoglycemia defined as glucose levels less than 60mg/dl (number of patients experienced at least one event x 100 %/(number of patients in the group) o The rate of preoperative glucose concentrations greater than 180mg/dl. o The postoperative site infection rate o The occurrence of acute renal insufficiency (a 25% change in creatinine from before surgery to after surgery) o The composite all-cause postoperative complications: all cause death, myocardial infarction, congestive heart failure or stroke (major cardiovascular events) until hospital discharge o The lengths of hospital stay (from admission to the hospital to discharge from the hospital) o and thereby gather estimates for the difference in outcome parameters in the target population in order to plan a multicenter study.
Efficacy of such a treatment as assessed by o blood profile (glucose, insulin, …), o the length of ICU stay o Time and costs of staff |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
o Age 18 – 75 years o Type 2 diabetes mellitus with diet alone or oral antidiabetic agents and/or insulin therapy o planned severe cardiovascular surgery o signed informed consent
|
|
E.4 | Principal exclusion criteria |
o mental condition rendering the patient unable to give informed consent o diagnosis and/or treatment of cancer during the last five years o impaired renal function (creatinine 3.0mg/dl) o diabetic ketoacidosis o HbA1c >13% o cardiothoracic surgery in the previous 12 months o Pregnant or breast-feeding patients
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
Is it possible and safe to achieve a preoperative target blood glucose level between 100 and 180 mg/dl with an IGC in patients with T2DM with severe planned cardiovascular surgery? |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
o The rate of preoperative hypoglycemia defined as glucose levels less than 60mg/dl (number of patients experienced at least one event x 100 %/(number of patients in the group) o The rate of preoperative glucose concentrations greater than 180mg/dl. o The postoperative site infection rate o The occurrence of acute renal insufficiency (a 25% change in creatinine from before surgery to after surgery) o The composite all-cause postoperative complications: all cause death, myocardial infarction, congestive heart failure or stroke (major cardiovascular events) until hospital discharge o The lengths of hospital stay (from admission to the hospital to discharge from the hospital) o and thereby gather estimates for the difference in outcome parameters in the target population in order to plan a multicenter study.
Efficacy of such a treatment as assessed by o blood profile (glucose, insulin, …), o the length of ICU stay o Time and costs of staff |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
|
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |