A Prospective Randomized Blinded Trial of Remote Ischemic Preconditioning in Children Undergoing Cardiac Surgery

Rodriguez, Maribel Carolina Verdesoto; Spenceley, Neil; Ilina, Maria; Danton, Mark

doi:10.1053/j.semtcvs.2019.12.004

Cited by 12 publications

(16 citation statements)

References 37 publications

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“…Cheung et al first demonstrated reductions in troponin release and perioperative inotropic requirements with RIPC in a heterogeneous cohort of 37 children, most of whom had either TOF or VSD, a similar population to our trial [7]. Several small studies found improved myocardial protection, with reduced early troponin release in infants and young children undergoing VSD closure [8,9], whilst others found no benefit in neonates or infants undergoing other operations for congenital heart disease [10][11][12]15]. In the largest paediatric trial of RIPC to date, McCrindle et al found no benefit in clinical outcomes, physiological biomarkers, or subgroup analyses in a mixed cohort of 299 children aged 0-17 years in Toronto, Canada [13] and proposed that better than expected outcomes in the control group, heterogeneity of underlying conditions, and use of propofol may have affected their findings.…”

Section: Discussionsupporting

confidence: 62%

“…The promise of this simple, low-risk, inexpensive and readily available intervention as an adjunct to current methods for myocardial protection during cardiac surgery has prompted numerous trials in adults [26][27][28][29][30][31] and children [7][8][9][10][11][12][13][14][15] but with mixed results. A meta-analysis suggested that RIPC reduces myocardial injury during cardiac surgery [32], but subsequently two large multi-centre trials in adults failed to show benefit in either composite cardiovascular endpoints or troponin release [30,31]; both were criticised for using propofol anaesthesia after it had been shown to interfere with the preconditioning pathway [16,17].…”

Section: Discussionmentioning

confidence: 99%

“…Remote ischaemic preconditioning (RIPC), the application of brief, non-lethal cycles of ischaemia and reperfusion to a distant organ or tissue, is a simple, low-risk and readily available technique which may improve myocardial protection. Previous trials of RIPC in children undergoing cardiac surgery have shown mixed results [7][8][9][10][11][12][13][14][15] and have been criticised for a potentially inadequate stimulus; a manual sphygmomanometer may allow sub-clinical reperfusion during the ischaemic phase of RIPC [13], and the use of propofol anaesthesia has been suggested to interfere with the preconditioning pathway [16,17]. In addition, they have not evaluated the effects of preoperative cyanosis on RIPC [18] and have only applied the cuff to a single limb, potentially delivering a subtherapeutic stimulus in young children with a lower skeletal muscle mass compared to adults.…”

Section: Introductionmentioning

confidence: 99%

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The Bilateral Remote Ischaemic Conditioning in Children (BRICC) trial: a two-centre, double-blind, randomised controlled trial in young children undergoing cardiac surgery

Drury

Doorn

Woolley

et al. 2023

Preprint

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Background and Aims: Previous trials evaluating remote ischaemic preconditioning in children undergoing cardiac surgery showed mixed results. We sought to determine whether adequately delivered bilateral preconditioning is cardioprotective in young children, with or without cyanosis, undergoing surgery. Methods: Prospective, double-blind, randomised controlled trial at two UK centres. Children aged 3-36 months undergoing tetralogy of Fallot repair or ventricular septal defect closure were randomised in a 1:1 ratio to receive either bilateral preconditioning or sham intervention. Participants were followed up until hospital discharge or 30 days. The primary outcome was area under the curve for high-sensitivity troponin-T in the first 24 hours after surgery, analysed by intention-to-treat. Right atrial biopsies were obtained in selected patients. Trial registration:ISRCTN12923441. Results: Between 24 October 2016 and 8 December 2020, 120 eligible children were randomised to receive either bilateral preconditioning (n=60) or sham intervention (n=60). Participants had a median age of 7 months and 42 (35%) were female. The primary outcome, area under the curve for hs-troponin-T was higher in the preconditioning group (mean: 70.0+/-50.9microg/L/hr, n=56) than in controls (mean: 55.6+/-30.1microg/L/hr, n=58), p=0.04. Sub-group analyses did not show a differential treatment effect by oxygen saturations (pinteraction=0.25) but showed evidence of differential treatment effect by underlying defect (pinteraction=0.04). Myocardial metabolism, quantified in atrial biopsies, and secondary outcomes were not different between randomised groups. Conclusions: Bilateral remote ischemic preconditioning does not attenuate myocardial injury in children undergoing surgical repair for congenital heart defects, and there was evidence of potential harm in unstented tetralogy of Fallot.

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Section: Discussionsupporting

confidence: 62%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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The Bilateral Remote Ischaemic Conditioning in Children (BRICC) trial: a two-centre, double-blind, randomised controlled trial in young children undergoing cardiac surgery

Drury

Doorn

Woolley

et al. 2023

Preprint

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“…Figure 1 is a flow diagram of the study and summarizes the process of trial selection. Thirteen eligible RCTs were identified that had enrolled 1,352 children randomly assigned to either RIPreC or control groups [ 17 – 29 ]. The main characteristics and methodological quality of these trials are summarized in Table 1 and Fig.…”

Section: Resultsmentioning

confidence: 99%

Remote ischemic preconditioning and clinical outcomes after pediatric cardiac surgery: a systematic review and meta-analysis

Wang

Wen

et al. 2023

BMC Anesthesiol

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Background The benefit of remote ischemia preconditioning (RIPreC) in pediatric cardiac surgery is unclear. The objective of this systematic review and meta-analysis was to examine the effectiveness of RIPreC in reducing the duration of mechanical ventilation and intensive care unit (ICU) length of stay after pediatric cardiac surgery. Methods We searched PubMed, EMBASE and the Cochrane Library from inception to December 31, 2022. Randomized controlled trials comparing RIPreC versus control in children undergoing cardiac surgery were included. The risk of bias of included studies was assessed using the Risk of Bias 2 (RoB 2) tool. The outcomes of interest were postoperative duration of mechanical ventilation and ICU length of stay. We conducted random-effects meta-analysis to calculate weighted mean difference (WMD) with 95% confidence interval (CI) for the outcomes of interest. We performed sensitivity analysis to examine the influence of intraoperative propofol use. Results Thirteen trials enrolling 1,352 children were included. Meta-analyses of all trials showed that RIPreC did not reduce postoperative duration of mechanical ventilation (WMD -5.35 h, 95% CI -12.12–1.42) but reduced postoperative ICU length of stay (WMD -11.48 h, 95% CI -20.96– -2.01). When only trials using propofol-free anesthesia were included, both mechanical ventilation duration (WMD -2.16 h, 95% CI -3.87– -0.45) and ICU length of stay (WMD -7.41 h, 95% CI -14.77– -0.05) were reduced by RIPreC. The overall quality of evidence was moderate to low. Conclusions The effects of RIPreC on clinical outcomes after pediatric cardiac surgery were inconsistent, but both postoperative mechanical ventilation duration and ICU length of stay were reduced in the subgroup of children not exposed to propofol. These results suggested a possible interaction effect of propofol. More studies with adequate sample size and without intraoperative propofol use are needed to define the role of RIPreC in pediatric cardiac surgery.

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“…4b). The serum IL-6 level at 24 hours after surgery was reported in 13 trials, 4,9,12,21,22,34,36,38,55,56,62,64,65 which did not show statistical signi cance (SMD − 0.4, 95% CI -0.9 to 0.1, I 2 = 93%) (Fig. 4b).…”

Section: Effect Of Ripc On In Ammatory Cytokine Levelsmentioning

confidence: 90%

Effect of remote ischemic preconditioning on lung function after surgery under general anesthesia: A systematic review and meta-analysis

Kashiwagi

Mihara

Yokoi

et al. 2023

Preprint

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Remote ischemic preconditioning (RIPC) protects organs from ischemia-reperfusion injury. Recent trials showed that RIPC improved gas exchange in patients undergoing lung or cardiac surgery. We performed a systematic search to identify randomized controlled trials involving RIPC in surgery under general anesthesia. The primary outcome was the PaO2/FIO2 (P/F) ratio at 24 hours after surgery. Secondary outcomes were A-a DO2, the respiratory index, duration of postoperative mechanical ventilation (MV), incidence of acute respiratory distress syndrome (ARDS), and serum cytokine levels. The analyses included 64 trials comprising 7232 patients. Patients with RIPC showed higher P/F ratio than controls (mean difference [MD] 36.6, 95% confidence interval (CI) 12.8 to 60.4, I2=69%). The cause of heterogeneity was not identified by the subgroup analysis. Similarly, A-a DO2 (MD 15.2, 95% CI -29.7 to -0.6, I2=87%) and respiratory index (MD -0.17, 95% CI -0.34 to -0.01, I2=94%) were lower in the RIPC group. Additionally, the RIPC group was weaned from MV earlier (MD -1.0 hours, 95% CI -1.5 to -0.4, I2=78%). Furthermore, the incidence of ARDS was lower in the RIPC group (relative risk 0.73, 95% CI 0.60 to 0.89, I2=0%). Our meta-analysis suggested that RIPC improved oxygenation after surgery under general anesthesia.

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A Prospective Randomized Blinded Trial of Remote Ischemic Preconditioning in Children Undergoing Cardiac Surgery

Cited by 12 publications

References 37 publications

The Bilateral Remote Ischaemic Conditioning in Children (BRICC) trial: a two-centre, double-blind, randomised controlled trial in young children undergoing cardiac surgery

The Bilateral Remote Ischaemic Conditioning in Children (BRICC) trial: a two-centre, double-blind, randomised controlled trial in young children undergoing cardiac surgery

Remote ischemic preconditioning and clinical outcomes after pediatric cardiac surgery: a systematic review and meta-analysis

Effect of remote ischemic preconditioning on lung function after surgery under general anesthesia: A systematic review and meta-analysis

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