RecruitingPhase 4ACTRN12619000621112

A study of the local anaesthetic lidocaine and the antibiotic doxycycline to help protect the blood vessel lining in patients undergoing heart surgery.

Preserving the endothelial glycocalyx in patients undergoing cardiopulmonary bypass. A prospective randomised interventional pilot study of doxycycline and lidocaine.

Sponsor

Hearty and Lung Institute of Western Australia

Enrollment

60 participants

Start Date

Feb 3, 2020

Study Type

Interventional

Conditions

Valvular Heart Disease Aortic Disease

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.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study is investigating whether two common drugs — the local anaesthetic lidocaine (given by IV drip) and the antibiotic doxycycline — can protect the delicate inner lining of blood vessels (called the endothelial glycocalyx) during heart surgery. This protective layer plays an important role in regulating bleeding, swelling, and inflammation, and heart surgery is known to damage it — potentially contributing to organ damage and slow recovery. Adult patients undergoing heart surgery requiring cardiopulmonary bypass will be randomly assigned to receive lidocaine, doxycycline, or neither (standard care). Blood tests taken before and after surgery will measure markers of glycocalyx damage to see if either drug provides protection. You may be eligible if you are an adult (18 or over) undergoing heart surgery that requires a heart-lung bypass machine and can provide informed consent. People who are allergic to either study drug, have known liver disease, or have alcoholism cannot participate. This Phase 4 study led by the Heart and Lung Institute of Western Australia aims to identify simple, inexpensive ways to protect the body during one of medicine's most complex procedures.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.