Feasibility and safety of preoperative glucose control in patients with type 2 diabetes undergoing cardiovascular surgery

Feasibility and safety of intensified preoperative glucose control in patients with type 2 diabetes undergoing cardiovascular surgery – a pilot study - Diabetes and cardiothoracic surgery

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-000980-42-AT

Enrollment

Registered

2014-09-02

Start date

2014-09-26

Completion date

Unknown

Last updated

2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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.

Interventions

Trade Name: Novo Rapid Product Name: NovoRapid Product Code: EMEA/H/C/000258 Pharmaceutical Form: Solution for injection/infusion INN or Proposed INN: INSULIN ASPART CAS Number: 116094-23-6 Current Sp

Eligibility

Sex/Gender

All

Inclusion criteria

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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Main Objective: 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?;Secondary Objective: 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;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?;Timepoint(s) of evaluation of this end point: end of trail	—

Measure

Time frame

Main Objective: 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?;Secondary Objective: 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;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?;Timepoint(s) of evaluation of this end point: end of trail

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Secondary

Measure	Time frame
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;Timepoint(s) of evaluation of this end point: end of trail	—

Measure

Time frame

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;Timepoint(s) of evaluation of this end point: end of trail

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Countries

Austria

Contacts

Public ContactRenate Kruschitz

Medical University Vienna

renate.kruschitz@meduniwien.ac.at00431404004364

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 7, 2026