Extract

Background and study aims Dengue is emerging as a major public health issue around the world, and is a very common infection in Vietnam. In a small proportion of cases serious complications occur. In particular some patients develop a problem where the small blood vessels become leaky for a few days, allowing the blood plasma to leak out, and sometimes this leads to shock. At the moment there is no specific treatment available to counteract the leaking, but we think that if we can understand what happens to make the small blood vessels leak we may able to treat this complication more effectively. One way to understand what happens is to give a small infusion of a special kind of carbohydrate (Dextran) solution to a person with dengue and look at the way the carbohydrate leaks out of the blood vessels by measuring the concentration of the carbohydrate in the blood and urine at intervals over a couple of hours after an infusion. The technique is quite safe and is used in studies of many conditions where there is a problem with leaking blood vessels, and is also used to find out about changes to the blood vessels during pregnancy. Who can participate? Healthy individuals and patients with dengue aged from 18-30 years old. What does the study involve? The carbohydrate infusion will be administered over 2 hours with the participants lying comfortably at rest. A special device for blood sampling will be inserted to allow repeated small blood samples to be obtained at intervals during the 2 hours, together with simultaneous urine samples. The rate of clearance of the carbohydrate from the blood to the urine will be compared in the dengue patients during acute illness with the values in the same patients during recovery, and also with the results from the healthy volunteers. What are the possible benefits and risks of participating? There are no specific benefits to the participants at the time of the study, apart from the knowledge that their involvement might lead to improved management of dengue cases in the future. There are very few risks to the study participants; occasionally a person may be allergic to the carbohydrate solution, but the same solution is used very frequently in Vietnam as a treatment for dengue and allergic reactions are extremely uncommon here. In any case patients are monitored very closely during the infusion, and all necessary treatment for an allergic reaction is immediately available if this does occur. There may be minor bruising at the site of blood sampling. Where is the study run from? The study was run by researchers at the Oxford University Clinical Research Unit (OUCRU) – Viet Nam; and Hospital for Tropical Diseases HCMC (HTD). When is the study starting and how long is it expected to run for? The study ran from August 2008 to July 2009. Who is funding the study? The Wellcome Trust (UK). Who is the main contact? The Clinical Trials Unit at the Oxford University Clinical Research Unit – Viet Nam +84 839241983

Inclusion criteria

• Dengue fever

Links

• ictrp
• isrctn