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      Intravenous Iron Isomaltoside 1000 Reduces Postoperative Anemia in Patients Undergoing Elective Urologic Surgery and Those with Urosepsis

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          Abstract

          Purpose

          Postoperative anemia is associated with increased morbidity and mortality in patients undergoing surgery. Anemia is also a common feature during sepsis. Therefore, here, we aimed to investigate the safety and efficacy of intravenous iron isomaltoside 1000 (Monofer ®) in patients undergoing elective urologic surgery and in those with urosepsis.

          Materials and Methods

          This multicenter study was conducted through the review of the medical records of patients with postoperative anemia undergoing elective urologic surgery or with urosepsis in a multicenter hospital. Patients received a single intravenous iron isomaltoside (IIM), and their hemoglobin (Hb) level was evaluated before and after administration of IIM. Safety data included adverse effects and hypersensitivity reactions. In addition, the patients were divided into three groups (200 mg, 400 mg, and 600 mg IIM) to compare Hb changes before and after the administration of IIM.

          Results

          The study analyzed 52 men and 30 women with a mean age of 67 years. There was a significant difference between pre-treatment Hb and post-treatment Hb according to the type of the surgery after administration (p=0.01) of IIM in patients with postoperative anemia, and the mean preoperative Hb before IIM administration was 8.5 g/dL and that after IIM administration was 9.9 g/dL (p=0.006) in patients with urosepsis. The mean preoperative Hb changed from 10 g/dL to 11 g/dL after administration (p<0.001) of IIM in the whole cohort. There were no side effects due to the administration of intravenous IIM.

          Conclusion

          A single perioperative intravenous injection of IIM 1000 significantly increased the Hb level in patients with anemia who underwent urologic elective surgery. Moreover, this treatment can be considered to have potential clinical benefits for anemia caused by sepsis.

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          Most cited references 32

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          Early Goal-Directed Therapy in the Treatment of Severe Sepsis and Septic Shock

          Goal-directed therapy has been used for severe sepsis and septic shock in the intensive care unit. This approach involves adjustments of cardiac preload, afterload, and contractility to balance oxygen delivery with oxygen demand. The purpose of this study was to evaluate the efficacy of early goal-directed therapy before admission to the intensive care unit. We randomly assigned patients who arrived at an urban emergency department with severe sepsis or septic shock to receive either six hours of early goal-directed therapy or standard therapy (as a control) before admission to the intensive care unit. Clinicians who subsequently assumed the care of the patients were blinded to the treatment assignment. In-hospital mortality (the primary efficacy outcome), end points with respect to resuscitation, and Acute Physiology and Chronic Health Evaluation (APACHE II) scores were obtained serially for 72 hours and compared between the study groups. Of the 263 enrolled patients, 130 were randomly assigned to early goal-directed therapy and 133 to standard therapy; there were no significant differences between the groups with respect to base-line characteristics. In-hospital mortality was 30.5 percent in the group assigned to early goal-directed therapy, as compared with 46.5 percent in the group assigned to standard therapy (P = 0.009). During the interval from 7 to 72 hours, the patients assigned to early goal-directed therapy had a significantly higher mean (+/-SD) central venous oxygen saturation (70.4+/-10.7 percent vs. 65.3+/-11.4 percent), a lower lactate concentration (3.0+/-4.4 vs. 3.9+/-4.4 mmol per liter), a lower base deficit (2.0+/-6.6 vs. 5.1+/-6.7 mmol per liter), and a higher pH (7.40+/-0.12 vs. 7.36+/-0.12) than the patients assigned to standard therapy (P < or = 0.02 for all comparisons). During the same period, mean APACHE II scores were significantly lower, indicating less severe organ dysfunction, in the patients assigned to early goal-directed therapy than in those assigned to standard therapy (13.0+/-6.3 vs. 15.9+/-6.4, P < 0.001). Early goal-directed therapy provides significant benefits with respect to outcome in patients with severe sepsis and septic shock.
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            Intraoperative transfusion of 1 U to 2 U packed red blood cells is associated with increased 30-day mortality, surgical-site infection, pneumonia, and sepsis in general surgery patients.

            Transfusion of packed red blood cells (PRBCs) increases morbidity and mortality in select surgical specialty patients. The impact of low-volume, leukoreduced RBC transfusion on general surgery patients is less well understood. The American College of Surgeons National Surgical Quality Improvement Program participant use file was queried for general surgery patients recorded in 2005 to 2006 (n = 125,223). Thirty-day morbidity (21 uniformly defined complications) and mortality, demographic, preoperative, and intraoperative risk variables were obtained. Infectious complications and composite morbidity and mortality were stratified across intraoperative PRBCs units received. Multivariable logistic regression was used to assess influence of transfusion on outcomes, while adjusting for transfusion propensity, procedure type, wound class, operative duration, and 30+ patient risk factors. After adjustment for transfusion propensity, procedure group, wound class, operative duration, and all other important risk variables, 1 U PRBCs significantly (p < 0.05) increased risk of 30-day mortality (odds ratio [OR] = 1.32), composite morbidity (OR = 1.23), pneumonia (OR = 1.24), and sepsis/shock (OR = 1.29). Transfusion of 2 U additionally increased risk for these outcomes (OR = 1.38, 1.40, 1.25, 1.53, respectively; p
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              Risk associated with preoperative anemia in cardiac surgery: a multicenter cohort study.

              Preoperative anemia is an important risk factor for perioperative red blood cell transfusions, which are associated with postoperative morbidity and mortality. Whether preoperative anemia also is an independent risk factor for adverse outcomes after cardiac surgery, however, has not been fully elucidated. In this multicenter cohort study, data were collected on 3500 consecutive patients who underwent cardiac surgery during 2004 at 7 academic hospitals. The prevalence of preoperative anemia, defined as hemoglobin <12.5 g/dL, and its unadjusted and adjusted relationships with the composite outcome of in-hospital death, stroke, or acute kidney injury were obtained. The overall prevalence of preoperative anemia was 26%, with values ranging from 22% to 30% at the participating hospitals. After the exclusion of patients who had severe preoperative anemia (hemoglobin <9.5 g/dL) or preoperative kidney failure and those who underwent emergency surgery, the composite outcome was observed in 7.5% of patients (247 of 3286). The unadjusted odds ratio for the composite outcome in anemic versus nonanemic patients was 3.6 (95% confidence interval, 2.7 to 4.7). The risk-adjusted odds ratios, obtained by multivariable logistic regression and propensity-score matching to control for important confounders (including comorbidities, institution, surgical factors, and blood transfusion), were 2.0 (95% confidence interval, 1.4 to 2.8) and 1.8 (95% confidence interval, 1.2 to 2.7), respectively. Preoperative anemia is independently associated with adverse outcomes after cardiac surgery. Future studies should determine whether therapies aimed at treating preoperative anemia would improve the outcomes of patients undergoing cardiac surgery.
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                Author and article information

                Journal
                Drug Des Devel Ther
                Drug Des Devel Ther
                dddt
                dddt
                Drug Design, Development and Therapy
                Dove
                1177-8881
                23 December 2020
                2020
                : 14
                : 5679-5687
                Affiliations
                [1 ]Department of Urology, Dong-A University, College of Medicine , Busan, Korea
                [2 ]Department of Anesthesia and Pain Medicine, Hanyang University, College of Medicine , Seoul, Korea
                [3 ]Department of Urology, Hanyang University, College of Medicine , Seoul, Korea
                [4 ]Department of Urology, Soonchunghyang University Hospital , Seoul, Korea
                Author notes
                Correspondence: Jung Ki Jo Department of Urology, Hanyang University, College of Medicine , 222-1 Wangsimni-ro, Seongdong-gu, Seoul04763, KoreaTel +821025196241 Email victorjo38@hanyang.ac.kr
                Article
                276904
                10.2147/DDDT.S276904
                7767719
                33380788
                © 2020 Goh et al.

                This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License ( http://creativecommons.org/licenses/by-nc/3.0/). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms ( https://www.dovepress.com/terms.php).

                Page count
                Figures: 3, Tables: 7, References: 32, Pages: 9
                Categories
                Original Research

                Pharmacology & Pharmaceutical medicine

                iron, anemia, iron isomaltoside 1000, urosepsis

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