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

Phase 4

Completed

Conditions: diabetes mellitus
10018424

Registration Number: NL-OMON31049

Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

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, diet-restrictions, or a combination.
- Age over 18 years
- Male or female
- Able and willing to give informed consent

Exclusion Criteria

- Patients scheduled for surgery in day-care or emergency surgery
- Psychiatric or mentally challenged patients unable to give informed consent
- Patients with 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

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study endpoint will be the occurrence of cardiovascular complications<br /><br>and death from all causes during follow-up (30 days and 1 year) after elective<br /><br>non-cardiac surgery, comparing those with conventional to those with intensive<br /><br>perioperative blood glucose control.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Complications such as infections, venous thrombosis and severe haemorhage at<br /><br>30 days and 1 year after non-cardiac surgery.<br /><br>- Furthermore, number of days in intensive care and in hospital, and ICU<br /><br>mortality and hospital mortality will be studied.<br /><br>- Changes in coagulation and inflammatory factors in the perioperative period,<br /><br>and changes in these factors due to intensive perioperative blood glucose<br /><br>control instead of conventional glucose control</p><br>