PRACDICAL Study Prevention and Risk factors of Arterial Complications in DIabetics after non-CArdiac surgicaL interventions - PRACDICAL study

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-000223-17-NL

Enrollment

2000

Registered

2007-08-29

Start date

2008-02-26

Completion date

Unknown

Last updated

2012-03-19

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

Conditions

Diabetes Mellitus

Interventions

Trade Name: Actrapid HM 1000 IE/10 ml, Novo Nordisk, Copenhagen, Denmark Reg name: Actrapid 100 IE/ml Product Name: Actrapid HM , Novo Nordisk, Copenhagen, Denmark Product Code: EU/1/02/230/004 Pha

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Patients with type 1 or type 2 diabetes undergoing elective non-cardiac surgery. Patients are either treated with oral hypoglycaemic agents, insulin or diet-restrictions. - Age over 18 years - male or female - Able and willing to give 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Patients scheduled for surgery in day-care or emergency surgery - Psychiatric or mentally challenged patients (or patients with other disorders who will have difficulty filling out the questionnaires) - Patients with severe liver disease: Criteria: Child Pugh B or C, or bilirubinuria, elevation of serum bilirubin (>35 mmol/L), elevated aminotransferase levels (>500 U/L), elevated alkaline phosphatase (>4 times normal values), albumin 1.7 - Patients who do not speak Dutch or English - Patients who are planned to be admitted postoperatively to the Intensive Care Unit (ICU) since in all ICUs a protocol on intensive glycaemic control is employed.

Design outcomes

Primary

Measure	Time frame
Main Objective: To study the effect of intensive blood glucose control intraoperatively and 24 hours postoperatively on developing cardiovascular complications and death of all causes at 30 days and one year after non-cardiac surgery in diabetics.;Secondary Objective: -To study the effect of intensive blood glucose control intraoperatively and 24 hours postoperatively on infectious complications, number of days in intensive care and hospital, severe haemorrhage, and venous thrombosis at 30 days and one year after non-cardiac surgery in diabetics. -To study the effect of intensive blood glucose control intraoperatively and 24 hours postoperatively on coagulation and inflammatory factor levels, and the change in coagulation and inflammatory factor levels during non-cardiac surgery in different groups of diabetic patients. -To study the role of inflammation and coagulation on developing cardiovascular, infectious, haemorrhagic and thrombotic complications at 30 days and one year after non-cardiac surgery in diabetics ;Primary end point(s): The main study endpoints will be cardiovascular complications and death from all causes at 30 days and 1 year after non-cardiac surgery, comparing patients with diabetes mellitus undergoing conventional or intensive perioperative blood glucose control.	—

Measure

Time frame

Main Objective: To study the effect of intensive blood glucose control intraoperatively and 24 hours postoperatively on developing cardiovascular complications and death of all causes at 30 days and one year after non-cardiac surgery in diabetics.;Secondary Objective: -To study the effect of intensive blood glucose control intraoperatively and 24 hours postoperatively on infectious complications, number of days in intensive care and hospital, severe haemorrhage, and venous thrombosis at 30 days and one year after non-cardiac surgery in diabetics. -To study the effect of intensive blood glucose control intraoperatively and 24 hours postoperatively on coagulation and inflammatory factor levels, and the change in coagulation and inflammatory factor levels during non-cardiac surgery in different groups of diabetic patients. -To study the role of inflammation and coagulation on developing cardiovascular, infectious, haemorrhagic and thrombotic complications at 30 days and one year after non-cardiac surgery in diabetics ;Primary end point(s): The main study endpoints will be cardiovascular complications and death from all causes at 30 days and 1 year after non-cardiac surgery, comparing patients with diabetes mellitus undergoing conventional or intensive perioperative blood glucose control.

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Countries

Netherlands

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026