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Levosimendan for patients with heart failure undergoing major oncological surgery: A randomised blinded pilot study.

ABSTRACT: Background and Aims:Cardiovascular diseases and cancer are among the leading causes of mortality worldwide. The aim of this study is to evaluate the efficacy and safety of preoperative administration of levosimendan in patients with chronic heart failure (CHF) scheduled for major abdominal oncologic surgery. Methods:This study included 60 patients with abdominal malignancy, ejection fraction (EF) <35% and CHF scheduled for surgery under isoflurane-fentanyl anaesthesia and were managed in the surgical intensive care unit perioperatively. They were randomised to receive levosimendan infusion (n = 30) at a dose of 0.1 ?g/kg/min or placebo (n = 30) for 24 hours before surgery. Results:The risk of hypotension (RR: 0.40, 95% CI: 0.19-0.83) or decompensated heart failure (RR: 0.31, 95% CI: 0.12-0.76) was significantly lower in the levosimendan group. The ejection fraction, cardiac index and stroke volume index were significantly higher in the levosimendan group after surgery (P < 0.001). Duration of postoperative ventilation and hospital stay were significantly shorter in the levosimendan group (P < 0.001) while the frequency of dysrhythmia, deterioration of renal function and sepsis was comparable. Conclusion:In patients with low EF <35% and CHF, administration of levosimendan for 24 hours before major abdominal oncologic surgeries may reduce the risk of hypotension and decompensated heart failure and may improve cardiac function.

SUBMITTER: Shaker EH

PROVIDER: S-EPMC6921323 | biostudies-literature | 2019 Dec

REPOSITORIES: biostudies-literature

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Levosimendan for patients with heart failure undergoing major oncological surgery: A randomised blinded pilot study.

Shaker Ehab H EH Hussein Khaled K Reyad Ehab M EM

Indian journal of anaesthesia 20191211 12

<h4>Background and aims</h4>Cardiovascular diseases and cancer are among the leading causes of mortality worldwide. The aim of this study is to evaluate the efficacy and safety of preoperative administration of levosimendan in patients with chronic heart failure (CHF) scheduled for major abdominal oncologic surgery.<h4>Methods</h4>This study included 60 patients with abdominal malignancy, ejection fraction (EF) <35% and CHF scheduled for surgery under isoflurane-fentanyl anaesthesia and were man ...[more]

PMID: 31879424

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Project description:BackgroundLevosimendan has pharmacologic and hemodynamic advantages over conventional intravenous inotropic agents. It has been used mainly as a rescue drug in the pediatric intensive care unit or in the operating room. We present the largest single-center experience of levosimendan in children.MethodsRetrospective analysis of all children who received levosimendan infusions between July 5, 2001 and July 4, 2010 in a pediatric intensive care unit. The results of a questionnaire for physicians (anesthesiologist/intensivists, cardiologists and cardiac surgeons) concerning their clinical perceptions of levosimendan are evaluatedResultsDuring the study period a total of 484 infusions were delivered to 293 patients 53% of whom were male. The median age of the patients was 0.4 years (4 hours-21.1 years) at the time of levosimendan administration. A majority of levosimendan infusions were administered to children who were undergoing cardiac surgery (72%), 14% to children with cardiomyopathy and 14% to children with cardiac failure. Eighty-nine out of the 293 patients (30.4%) received repeated doses of levosimendan (up to 11 infusions). The most common indication for the use of levosimendan (94%) was when the other inotropic agents were insufficient to maintain stable hemodynamics. Levosimendan was especially used in children with cardiomyopathy (100%) or with low cardiac output syndrome (94%). A majority (89%) of the respondents believed that levosimendan administration postponed the need for mechanical assist devices in some children with cardiomyopathy. Moreover, 44% of respondents thought that the mechanical support was totally avoided in some patients undergoing cardiac surgery after receiving levosimendan.ConclusionLevosimendan is widely used in our institution and many physicians believe that its use could decrease the need for mechanical support in children undergoing cardiac surgery or in children with decompensated heart failure. However, there is a lack of good empirical evidence in children to support this perception.

Project description:There is equipoise regarding the use of prothrombin complex concentrate vs. fresh frozen plasma in bleeding patients undergoing cardiac surgery. We performed a pilot randomised controlled trial to determine the recruitment rate for a large trial, comparing the impact of prothrombin complex concentrate vs. fresh frozen plasma on haemostasis (1 h and 24 h post-intervention), and assessing safety. Adult patients who developed bleeding within 24 h of cardiac surgery that required coagulation factor replacement were randomly allocated to receive prothrombin complex concentrate (15 IU.kg-1 based on factor IX) or fresh frozen plasma (15 ml.kg-1 ). If bleeding continued after the first administration of prothrombin complex concentrate or fresh frozen plasma administration, standard care was administered. From February 2019 to October 2019, 180 patients were screened, of which 134 (74.4% (95%CI 67-81%)) consented, 59 bled excessively and 50 were randomly allocated; 25 in each arm, recruitment rate 35% (95%CI 27-44%). There were 23 trial protocol deviations, 137 adverse events (75 prothrombin complex concentrate vs. 62 fresh frozen plasma) and 18 serious adverse events (5 prothrombin complex concentrate vs. 13 fresh frozen plasma). There was no increase in thromboembolic events with prothrombin complex concentrate. No patient withdrew from the study, four were lost to follow-up and two died. At 1 h after administration of the intervention there was a significant increase in fibrinogen, Factor V, Factor XII, Factor XIII, α2 -antiplasmin and antithrombin levels in the fresh frozen plasma arm, while Factor II and Factor X were significantly higher in the prothrombin complex concentrate group. At 24 h, there were no significant differences in clotting factor levels. We conclude that recruitment to a larger study is feasible. Haemostatic tests have provided useful insight into the haemostatic changes following prothrombin complex concentrate or fresh frozen plasma administration. A definitive trial is needed to ascertain the benefits and safety for each.

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Levosimendan for patients with heart failure undergoing major oncological surgery: A randomised blinded pilot study.

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Levosimendan for patients with heart failure undergoing major oncological surgery: A randomised blinded pilot study.

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