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PRACDICAL study Prevention of Risk Factors of Arterial Complications in...

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Title PRACDICAL study Prevention of Risk Factors of Arterial Complications in Diabetics after Non-cardial Surgical Interventions
Period 09 / 2007 - unknown
Status Current
Research number OND1326347
Data Supplier Website ZonMw

Abstract

The primary objective is to study the effect of intensive blood glucose control intraoperatively and 24 hours postoperatively on the development of cardiovascular complications and death from all causes after elective non-cardiac surgery in diabetics.The secondary objectives are 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. Furthermore, to study the effect of intensive blood glucose control intraoperatively and 24 hours postoperatively on coagulation and inflammatory factor levels.Research questionsPrimary: What is the effect of intensive blood glucose control intraoperatively and 24 hours postoperatively on developing cardiovascular complications and death from all causes after elective non-cardiac surgery in diabetics? Secondary: What is 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? What is the effect of intensive blood glucose control intraoperatively and 24 hours postoperatively on coagulation and inflammatory factor levels? What is the role of coagulation and inflammation on developing cardiovascular, infectious, haemorrhagic and thrombotic complications? Surgery is a major cause of cardiovascular morbidity and mortality in diabetic patients. Intensive glucose control during surgery has been shown to reduce the systemic inflammatory response and morbidity and mortality in patients undergoing coronary artery bypass grafting. However, not much is known about the beneficial effect of intensive glycemic control during non-cardiac surgery. This information is of great importance as the incidence of diabetics is increasing rapidly, as is the number of diabetics undergoing non-cardiac surgery, which comprises the majority of surgeries. Beside conventional risk factors, impaired regulation of coagulation (i.e. clotting of the blood) and inflammation during and after surgery might play an important role in elevating the risk of cardiovascular complications such as myocardial infarction, stroke, and subsequent death. However, no data are available yet on the clinical relevance of increased coagulation and inflammation during surgery. In this two-arm double blind randomized controlled trial we aim to assess the effect of intensive blood glucose control intraoperatively and 24 hours postoperatively, and the role of inflammation and coagulation, on the occurrence of cardiovascular complications and death from all causes after non-cardiac surgery in diabetics. For this study, patients will be randomized to either (A) conventional glucose control intraoperatively and 24 h postoperatively according to prevailing practice whenever blood glucose levels exceed 12 mmol/L or (B) intensive glucose control by a strict algorithm when levels exceed 6.1 mmol/L from the start of surgery until 24 h postoperatively. If strict glycemic control shows a significant reduction of complications, the results of this study will have great impact on current medical daily practice.

Related organisations

Secretariat Haga Hospital
Collaboration Department of Anaesthesiology (UL)
Financier ZonMw

Related people

Project leader Dr. M.S. Arbous

Classification

D23220 Internal medicine
D23310 Surgery

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