None listed
Conditions
Brief summary
Heart surgery is known to cause damage to the inner lining of blood vessels called the "endothelial glycocalyx". This damage can affect bleeding, swelling and inflammation which can harm organs and delay recovery after surgery. Damage to this layer can be measured using special blood tests. Currently there are no drugs used to protect this layer during surgery. Some experiments have shown the commonly used local anaesthetic "lidocaine" and the antibiotic "doxycycline" may be of benefit to protect this layer. We propose a project in which patients undergoing heart surgery are randomly allocated to receive one or other of the medicines or neither (a "control" group). Blood tests will indicate if these medicines have an effect on this layer. We hypothesise that lidocaine and or doxycycline may protect the endothelial glycocalyx during heart surgery.
Interventions
Participants, patients undergoing elective or urgent surgery requiring cardiopulmonary bypass, will be randomised to 1 of 3 equal groups. The groups consist of a control group, a group receiving intravenous lidocaine (1.5mg/kg bolus followed by 2mg/kg/hr infusion) during their operation, a group receiving oral doxycycline (200mg tablet) in the holding bay 0-90mins prior to being brought into theatre.
Sponsors
Hearty and Lung Institute of Western Australia
Study design
Allocation
Randomised controlled trial
Intervention model
Factorial
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
All adult patients with capacity to consent undergoing operations requiring cardiopulmonary bypass.
Exclusion criteria
Unable to consent/ refusal. Hypersensitivity to study drugs. Operations not requiring cardiopulmonary bypass. Known or suspected liver disease Alcoholism
Outcome results
None listed