Effect of intralipid on myocardial injury during valve replacement surgery with concomitant radiofrequency ablation

et al. 2020

Preprint

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Background Intralipid is a necessary fatty acid carrier that has been safely used as an energy supplier in the clinic. It has played an important role in rescuing the cardiac arrest caused by local anesthetic toxicity. In recent years, experimental studies have shown that intralipid postconditioning (ILPC) could reduce myocardial ischemic/reperfusion (I/R) injuries. Our research group has innovatively conducted a pilot randomized controlled trial (RCT) and the results showed that ILPC could reduce the release of cTnT and CK-MB, biomarkers of myocardial I/R injury, in valve replacement surgery. However, the potential effects of ILPC on the clinical outcome of adult cardiac surgery patients are unclear. Intralipid postconditioning in patients of cardiac surgery undergoing cardiopulmonary bypass (iCPB) trial is aimed to further study whether ILPC could improve short-term and long-term clinical outcome, as well as cardiac function in adult cardiac surgery patients. Methods The iCPB trial is an ongoing, single-center, prospective, double blinded, large sample RCT. In total, 1000 adults undergoing cardiac surgery will be randomly allocated to either ILPC group or the control group. Intervention group received an intravenous infusion of 2 mL/kg of 20% intralipid (medium-chain and long-chain fat emulsion injection C6~C24, Pharmaceutical) within 10 minutes before aortic cross-unclamping, and the control group received an equivalent volume of normal saline. The primary endpoints are complex morbidity of major complications during hospitalization, and all-cause mortality within 30 days after surgery. The secondary endpoints include: (1) all-cause mortality 6 months and 1 year postoperatively, (2) the quality of life within 1 year after surgery,using QoR-15 questionnaire, (3) the postoperative cardiac function evaluated by LVEF, LVEDs, LVEDD, and the myocardial injury evaluated by CK-MB, cTnT, BNP, (4) short-term clinical outcomes during hospitalization and total cost are also detailed evaluated. Discussion The iCPB trial is the first to explore ILPC on the clinical outcome of adult cardiac surgery patients. The results are expected to provide potential evidences about whether ILPC could reduce the morbidity and mortality, improve the cardiac function and quality of life. Therefore, provide a rationale for the evaluation of the potentially clinically relevant benefit of intralipid therapy.

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Intralipid postconditioning in patients of Cardiac surgery undergoing cardioPulmonary Bypass (iCPB): study protocol for a randomized controlled trial

et al. 2020

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“…Our research group has conducted a pilot study and showed promising results that ILPC induced a significant reduction of postoperative cTnT and CK-MB release in patients undergoing cardiac valve replacement surgery [18,19]. Moreover, a single intravenous bolus of intralipid(2 mL/kg, 20% intralipid) did not bring abnormal lipid metabolism and was found to be safe, with no perioperative hepatic or renal dysfunction or any other significant related complications [18,19]. However, the sample size of the pilot study is small, and it is uncertain to know its influence on patient outcome.…”

Section: Discussionmentioning

confidence: 99%

“…Secondly, since the inhaled anesthetic sevoflurane is considered to be significantly cardioprotective and the high-dose propofol has also been reported to have a certain myocardial protective effect [26][27][28], both of which are currently widely used in clinical anesthetics, how to reduce their interference on the results of intralipid postconditioning is of great importance. In our previous pilot study [18,19], all included patients were given total intravenous anesthesia to eliminate the interference of sevoflurane. However, this does not rule out the role of propofol and is also not consistent with clinical practice.…”

Section: Discussionmentioning

confidence: 99%

“…Based on the above background, our research group has innovatively conducted a pilot randomized controlled trial (RCT) to investigate whether ILPC would display the same cardioprotective effects in patients of cardiac surgeries, who were inevitably subject to I/R during cardiopulmonary bypass (CPB) [18,19]. The results showed that ILPC could reduce the release of myocardial damage biomaker of serum cardiac troponin T(cTnT) and creatine kinase-MB (CK-MB) after cardiac valve replacement surgery, and the total 72-hour postoperative area under the curve (AUC) of cTnT and CK-MB were significantly reduced by 32.3% and 26.4% compared with control, respectively [18].…”

Section: Introductionmentioning

confidence: 99%

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Intralipid postconditioning in patients of Cardiac surgery undergoing cardioPulmonary Bypass (iCPB): study protocol for a randomized controlled trial

et al. 2020

Preprint

Self Cite

Background: Intralipid is a necessary fatty acid carrier that has been safely used as an energy supplier in the clinic. It has played an important role in rescuing the cardiac arrest caused by local anesthetic toxicity. In recent years, experimental studies have shown that intralipid postconditioning (ILPC) could reduce myocardial ischemic/reperfusion (I/R) injuries. Our research group has innovatively conducted a pilot randomized controlled trial (RCT) and the results showed that ILPC could reduce the release of cTnT and CK-MB, biomarkers of myocardial I/R injury, in valve replacement surgery. However, the potential effects of ILPC on the clinical outcome of adult cardiac surgery patients are unclear. Intralipid postconditioning in patients of cardiac surgery undergoing cardiopulmonary bypass (iCPB) trial is aimed to further study whether ILPC could improve short-term and long-term clinical outcome, as well as cardiac function in adult cardiac surgery patients.Methods: The iCPB trial is an ongoing, single-center, prospective, double blinded, large sample RCT. In total, 1000 adults undergoing cardiac surgery will be randomly allocated to either ILPC group or the control group. Intervention group received an intravenous infusion of 2 mL/kg of 20% intralipid (medium-chain and long-chain fat emulsion injection C6~C24, Pharmaceutical) within 10 minutes before aortic cross-unclamping, and the control group received an equivalent volume of normal saline. The primary endpoints are complex morbidity of major complications during hospitalization, and all-cause mortality within 30 days after surgery. The secondary endpoints include: (1) all-cause mortality 6 months and 1 year postoperatively, (2) the quality of life within 1 year after surgery，using QoR-15 questionnaire, (3) the postoperative cardiac function evaluated by LVEF, LVEDs, LVEDD, and the myocardial injury evaluated by CK-MB, cTnT, BNP, (4) short-term clinical outcomes during hospitalization and total cost are also detailed evaluated.Discussion: The iCPB trial is the first to explore ILPC on the clinical outcome of adult cardiac surgery patients. The results are expected to provide potential evidences about whether ILPC could reduce the morbidity and mortality, improve the cardiac function and quality of life. Therefore, provide a rationale for the evaluation of the potentially clinically relevant benefit of intralipid therapy.Trial registration: Chictr.org.cn, ChiCTR1900024387. Prospectively registered on 9 July 2019.

Intralipid postconditioning in patients of cardiac surgery undergoing cardiopulmonary bypass (iCPB): study protocol for a randomized controlled trial

et al. 2020

Trials

Self Cite

Background Intralipid is a necessary fatty acid carrier that has been safely used as an energy supplier in the clinic. It has played an important role in rescuing the cardiac arrest caused by local anesthetic toxicity. In recent years, experimental studies have shown that intralipid postconditioning (ILPC) could reduce myocardial ischemic/reperfusion (I/R) injuries. Our research group has innovatively conducted a pilot randomized controlled trial (RCT), and the results showed that ILPC could reduce the release of cTnT and CK-MB, biomarkers of myocardial I/R injury, in valve replacement surgery. However, the potential effects of ILPC on the clinical outcome of adult cardiac surgery patients are unclear. Intralipid postconditioning in patients of cardiac surgery undergoing cardiopulmonary bypass (iCPB) trial is aimed to further study whether ILPC could improve short-term and long-term clinical outcome, as well as cardiac function in adult cardiac surgery patients. Methods The iCPB trial is an ongoing, single-center, prospective, double-blinded, large sample RCT. In total, 1000 adults undergoing cardiac surgery will be randomly allocated to either the ILPC group or the control group. The intervention group received an intravenous infusion of 2 mL/kg of 20% intralipid (medium-chain and long-chain fat emulsion injection C6~C24, Pharmaceutical) within 10 min before aortic cross-unclamping, and the control group received an equivalent volume of normal saline. The primary endpoints are complex morbidity of major complications during hospitalization and all-cause mortality within 30 days after surgery. The secondary endpoints include (1) all-cause mortality 6 months and 1 year postoperatively; (2) the quality of life within 1 year after surgery, using the QoR-15 questionnaire; (3) the postoperative cardiac function evaluated by LVEF, LVEDS, and LVEDD, and the myocardial injury evaluated by CK-MB, cTnT, and BNP; and (4) short-term clinical outcomes during hospitalization and total cost are also detailed evaluated. Discussion The iCPB trial is the first to explore ILPC on the clinical outcome of adult cardiac surgery patients. The results are expected to provide potential evidences about whether ILPC could reduce the morbidity and mortality and improve the cardiac function and quality of life. Therefore, the results will provide a rationale for the evaluation of the potentially clinically relevant benefit of intralipid therapy. Trial registration Chictr.org.cn ChiCTR1900024387. Prospectively registered on 9 July 2019.