None listed
Conditions
Brief summary
Objectives of this study are to assess the effects of the remote ischemic preconditioning (RIPC) on the primary graft failure (PGF), heart function and multi-organ protection after heart transplantation. This is a prospective, multi-centre, double-blind randomized controlled clinical trial (RCT). The outcome of the study is expected to determine if significant protection by the RIPC previously achieved in animal study can be translated into clinical heart transplantation. Study Duration: Three years. Intervention is the RIPC stimulus (also referred to as ‘protocol’) which consists of four five-minute cycles of arm ischemia with intervening five minutes of reperfusion following induction of standard anaesthesia in the operating room, prior to heart transplantation (HT). Inflating a standard blood pressure cuff to a pressure exceeding systolic by 20 mmHg will interrupt blood flow. The cuff would be deflated during reperfusion. Control patients will have sham placement of cuff without inflation. Participants will be monitored after HT and an analysis of blood samples (involving an examination of markers of myocardial damage, i.e., troponin I) collected as a part of standard care will be used to determine if there are protective effects due to the RIPC protocol used. Number of Subjects: 50. Population: Adults and children aged >15 years undergoing heart transplantation for the first time.
Interventions
The intervention is the application of remote ischaemic preconditioning (RIPC) protocol to patients undergoing heart transplantation. The RIPC protocol will be instituted by four five-minute cycles of arm ischaemia with intervening five minutes of reperfusion following induction of standard anaesthesia in the operating room. Inflating a standard blood pressure cuff to a pressure exceeding systolic by 20 mmHg will interrupt blood flow. The cuff would be deflated during reperfusion. Blood flow int
The intervention is the application of remote ischaemic preconditioning (RIPC) protocol to patients undergoing heart transplantation. The RIPC protocol will be instituted by four five-minute cycles of arm ischaemia with intervening five minutes of reperfusion following induction of standard anaesthesia in the operating room. Inflating a standard blood pressure cuff to a pressure exceeding systolic by 20 mmHg will interrupt blood flow. The cuff would be deflated during reperfusion. Blood flow interruption and restoration will be documented by a standard finger pulse oximetry, which will serve to monitor adherence. Control patients will have sham placement of cuff without inflation. For early effect, the preconditioning will be performed after the patient has been anaesthetised while routine central lines are being placed, prior to heart transplantation.
Sponsors
Professor Igor E. Konstantinov
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
15 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Adults and children aged >15 years undergoing heart transplantation for the first time.
Exclusion criteria
Patients taking oral hypoglycaemic drugs (i.e., sulfonylurea derivatives, glyburide, or glibenclamide) will be excluded.
Outcome results
None listed