Extract

Background and study aims Generalised infection (sepsis) is a common reason for admission to intensive care. Intravenous fluid therapy (the infusion of liquid substances directly into a vein) is a vital part of treatment in order to treat shock and improve the blood flow generated by the heart (cardiac output). Special monitors measuring cardiac output are used to guide intravenous fluid therapy. However, this approach is restricted to intensive care as it requires expensive, invasive equipment and staff trained in using these devices. Therefore, there is a need to find other ways to guide fluid administration in patients in A&E or normal wards. It has been shown that doctors can be quickly trained to use non-invasive, hand-carried ultrasound devices. This equipment is relatively cheap, can be reused and could be made available outside of higher care wards. It allows measurement of blood flow speeds (velocities) within arm or leg arteries. We plan to investigate whether changes in blood flow velocities while breathing in and out measured in an elbow artery can be used to assess fluid status in patients with sepsis admitted to the high dependency or intensive care unit. These changes are larger if the patient’s blood volume is low and thus would benefit from further fluid administration. Specifically, we will investigate whether there is a specific blood flow velocity change which can predict whether the patient needs further fluid therapy, and whether measurement of the changes in blood flow velocities in response to passive leg raising (which transfers blood from leg veins to the heart) can be used for the same purpose. Who can participate? Adult patients who are being treated for sepsis but do not need assistance with breathing using a ventilator can take part. What does the study involve? Patients taking part in the study will have a number of measurements taken including blood pressure, heart rate and breathing rate. Measurements will also be taken from intravenous lines that the patient will already have in place as part of their care. An extra measurement will be taken using an ultrasound and this will measure the speed of the blood flowing through the elbow artery. After these measurements the patient will have their legs raised to 45 degrees using the controls on their bed, and the measurements will be repeated again. They will then be repositioned back to their initial position and be given a bag of fluid through a drip, after which the measurements will be repeated once more. What are the possible benefits and risks of participating? Assessing the effect of raising their legs on the blood flow generated by the heart might help us to more accurately determine whether intravenous fluid should be given. Furthermore, what we learn from this study may help us to treat patients with sepsis in the future. There is no financial benefit from participation in the study. Patients taking part in the study will be closely monitored with extra readings (from the monitors they will be attached to as part of their routine care) being recorded at the same time as measuring the speed of blood flow through an artery in their elbow. Measurements of the blood speed with an ultrasound machine will not carry any additional risk. Where is the study run from? James Cook University Hospital - Intensive Care and High Dependency Units (UK) When is study starting and how long is it expected to run for? April to August 2012 Who is funding the study? South Tees NHS Foundation Trust (UK) Who is the main contact? Dr Jost Mullenheim [email protected]

Inclusion criteria

• Sepsis, spontaneously breathing patients

Links

• ictrp
• isrctn