A Multicenter Trial of Remote Ischemic Preconditioning for Heart Surgery

Abstract

Upper-limb RIPC performed while patients were under propofol-induced anesthesia did not show a relevant benefit among patients undergoing elective cardiac surgery. (Funded by the German Research Foundation; RIPHeart ClinicalTrials.gov number, NCT01067703.).

Remote Ischaemic PrEconditioning of Human Myocardium (RIPE): study protocol for a double-blinded randomised controlled trial

“…In September 2013, after the beginning of our study, Thielmans' group published their findings showing that remote ischaemic preconditioning provides perioperative myocardial protection and improves the prognosis of patients undergoing elective CABG surgery [19]. Later, two large randomised trials revealed that remote ischaemic preconditioning did not improve clinical outcomes in patients undergoing elective on-pump cardiopulmonary bypass grafting with or without valve surgery [20,21]. Meanwhile, no study has ever truly shown that remote preconditioning of human myocardium is at all feasible.…”

Candidate Surrogate End Points for ESRD after AKI

“…Cardiac surgery is a common setting for clinical trials of AKI prevention. 25,26 An advantage of the postoperative environment in clinical trials of AKI is that the timing of the insult may be well defined, particularly for cardiac and vascular surgery, and thus, interventions can be delivered at a specific time relative to the anticipated/observed insult. A second advantage of the postoperative environment as a setting for clinical trials is that surgery is usually avoided in persons at high risk of mortality.…”

“…Cox proportional hazards regression was used to determine the association of eGFR decline with subsequent ESRD and mortality, with time at risk beginning at the time of postdischarge eGFR assessment. Fully adjusted models included the following covariates: age, sex, race, body mass index (linear spline with a knot at 25 kg/m 2 ), hypertension, baseline eGFR (linear spline with knots at 60 and 90 ml/min per 1.73 m 2 ), diabetes, congestive heart failure, peripheral arterial disease, cerebrovascular disease, lung disease, liver disease, angiotensin-converting enzyme inhibitor/angiotensin receptor blocker use, diuretic use, statin use, surgery type, laparoscopic procedure, and hospital day of surgical procedure (hospital days 0-4, 5-14, or [15][16][17][18][19][20][21][22][23][24][25][26][27][28][29][30]. Proteinuria was considered as a covariate, but it was missing in 90% of the study population and thus, not included in the primary analysis.…”

Remote ischemic preconditioning to prevent cardiac surgery-related acute kidney injury: how far away from a breakthrough?

“…These impressive study results coupled with the excellent risk/benefit/cost profile of RIPC strongly plead for implementation of this technique in cardiac surgery protocols. However, enthusiasm became largely tempered by two subsequent recently published large, multicenter, randomized trials in cardiac surgery patients (12,13). The Effect of Remote Ischemic Preconditioning on Clinical Outcomes in Patients Undergoing Coronary Artery Bypass Graft Surgery (ERICCA) trial found no effect of RIPC on the postoperative incidence of moderate and severe AKI as compared with control treatment (12).…”

“…The Effect of Remote Ischemic Preconditioning on Clinical Outcomes in Patients Undergoing Coronary Artery Bypass Graft Surgery (ERICCA) trial found no effect of RIPC on the postoperative incidence of moderate and severe AKI as compared with control treatment (12). The Remote Ischemic Preconditioning for Heart Surgery (RIP Heart) Study also reported no significant difference in occurrence of AKI between RIPC-and sham-treated patients (13). It is noteworthy that the majority of patients enrolled in these studies received propofol-induced anesthesia.…”