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

• Conditions: Diabetes Mellitus

• Registration Number: EUCTR2007-000223-17-NL
• Lead Sponsor: M.S. Arbous

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-08-29
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 2000

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

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 < 28, INR > 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified