Extrait

Background and study aims Fluids are routinely given to patients undergoing surgery to make up for fluid losses during the operation. The patient’s cardiac output (the amount of blood pumped by the heart) can be monitored to guide fluid treatment, but this requires expensive equipment. In all high-risk patients a thin tube is placed into a large vein in the chest (central venous catheter) for the measurement of blood pressure and for giving drugs. The levels of oxygen and carbon dioxide in the central venous blood can be measured using blood sampled from the central venous catheter. Changes in these levels could be used as markers of changes in cardiac output without the need for expensive equipment. In this study we want to investigate whether changes in these two markers can be used to assess changes in cardiac output. Who can participate? High-risk patients aged over 50 undergoing major open abdominal surgery. What does the study involve? Arterial and central venous catheters are placed for the monitoring of the patients' arterial and central venous blood pressure, respectively. Cardiac output is monitored by connecting the arterial catheter to a monitor. Blood samples for blood gas analysis are drawn from the arterial and central venous catheters in any patient being given fluids to increase their cardiac output. Levels of oxygen and carbon dioxide are measured from the blood samples and cardiac output is recorded. Another set of blood samples is taken and cardiac output is measured 5 minutes after the fluids have been given. In each patient we perform up to three measurements of the changes in cardiac output and oxygen and carbon dioxide levels in response to fluid treatment. What are the possible benefits and risks of participating? The additional blood being taken for the purpose of this study is 24 ml. This small amount is extremely unlikely to alter blood transfusion requirements as the average blood loss for open abdominal surgery is more than 500 ml. Where is the study run from? James Cook University Hospital (UK). When is the study starting and how long is it expected to run for? October 2010 to October 2011. Who is funding the study? 1. James Cook University Hospital Trust (UK) 2. NIHR Comprehensive Local Research Networks Flexibility and Sustainability Funding (UK) Who is the main contact? Dr Jost Mullenheim

Critère d'inclusion

• Improving outcomes in high risk surgical patients

Liens

• ictrp
• isrctn