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  1. Article ; Online: Analysis of oxidative stress, inflammation and endothelial function following intravenous iron in chronic kidney disease in the Iron and Heart Trial

    Xenophon Kassianides / Victoria Allgar / Iain C. Macdougall / Philip A. Kalra / Sunil Bhandari

    Scientific Reports, Vol 12, Iss 1, Pp 1-

    2022  Volume 8

    Abstract: Abstract Iron deficiency commonly affects patients with chronic kidney disease and has an important burden in disease trajectory and quality of life; nonetheless current guidelines do not advocate treatment of iron-deficiency without anemia in this ... ...

    Abstract Abstract Iron deficiency commonly affects patients with chronic kidney disease and has an important burden in disease trajectory and quality of life; nonetheless current guidelines do not advocate treatment of iron-deficiency without anemia in this patient group. Concerns exist regarding the potential effects of intravenous iron on oxidative stress, inflammation, and endothelial function. As part of a multicenter double-blinded randomized controlled clinical trial, we examined the effects of a single dose of intravenous iron vs. placebo on biomarkers of oxidative stress, inflammation and endothelial function in non-anemic iron deficient patients (serum ferritin < 100 μg/L and/or transferrin saturation < 20%) with chronic kidney disease (stage 3b-5). Fifty-four individuals were randomized to receive ferric derisomaltose (n = 26) or placebo (n = 28). Ferric derisomaltose was associated with a non-significant decrease in mean F2-isoprostane and no effect on thiobarbituric acid reactive substances when compared to placebo throughout follow up. No effect on inflammatory markers was observed. A modest but statistically significant rise in E-selectin was noted in the intravenous iron group at 1 month and 3 month follow-up (p = 0.030 and p = 0.002 respectively). These results suggest ferric derisomaltose administration in non-dialysis dependent chronic kidney disease patients who are iron deficient does not induce prolonged oxidative stress or inflammation. Larger trials are required to quantify the benefit of intravenous iron administration in this patient group.
    Keywords Medicine ; R ; Science ; Q
    Subject code 610
    Language English
    Publishing date 2022-04-01T00:00:00Z
    Publisher Nature Portfolio
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  2. Article ; Online: Feasibility of randomized controlled trials and long-term implementation of interventions

    Cathy Bulley / Pelagia Koufaki / Jamie Hugo Macdonald / Iain C. Macdougall / Thomas H. Mercer / Jane Scullion / Sharlene A. Greenwood

    Frontiers in Rehabilitation Sciences, Vol

    Insights from a qualitative process evaluation of the PEDAL trial

    2023  Volume 4

    Abstract: IntroductionA multi-site randomized controlled trial was carried out between 2015 and 2019 to evaluate the impacts on quality of life of an intradialytic exercise programme for people living with chronic kidney disease. This included a qualitative ... ...

    Abstract IntroductionA multi-site randomized controlled trial was carried out between 2015 and 2019 to evaluate the impacts on quality of life of an intradialytic exercise programme for people living with chronic kidney disease. This included a qualitative process evaluation which gave valuable insights in relation to feasibility of the trial and of the intervention in the long-term. These can inform future clinical Trial design and evaluation studies.MethodsA constructivist phenomenological approach underpinned face-to-face, semi-structured interviews. Purposive recruitment ensured inclusion of participants in different arms of the PEDAL Trial, providers with different roles and trial team members from seven Renal Units in five study regions. Following ethical review, those willing took part in one interview in the Renal Unit. Audio-recorded interviews were transcribed (intelligent verbatim) and inductively thematically analyzed.ResultsParticipants (n = 65) (Intervention arm: 26% completed; 13% who did not; Usual care arm: 13%; 46% women; 54% men; mean age 60 year) and providers (n = 39) were interviewed (23% PEDAL Trial team members). Three themes emerged: (1) Implementing the Intervention; (2) Implementing the trial; and (3) Engagement of the clinical team. Explanatory theory named “the Ideal Scenario” was developed, illustrating complex interactions between different aspects of intervention and trial implementation with the clinical context. This describes characteristics likely to optimize trial feasibility and intervention sustainability in the long-term. Key aspects of this relate to careful integration of the trial within the clinical context to optimize promotion of the trial in the short-term and engagement and ownership in the long-term. Strong leadership in both the clinical and trial teams is crucial to ensure a proactive and empowering culture.ConclusionNovel explanatory theory is proposed with relevance for Implementation Science. The “Ideal Scenario” is provided to guide trialists in pre-emptive and ...
    Keywords implementation ; feasibility ; sustainability ; chronic kidney disease ; hemodialysis ; exercise ; Other systems of medicine ; RZ201-999 ; Medical technology ; R855-855.5
    Language English
    Publishing date 2023-02-01T00:00:00Z
    Publisher Frontiers Media S.A.
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  3. Article ; Online: Use of Intravenous Iron Supplementation in Chronic Kidney Disease

    Iain C Macdougall / Peter Geisser

    Iranian Journal of Kidney Diseases, Vol 7, Iss 1, Pp 9-

    an Update

    2013  Volume 22

    Abstract: Iron deficiency is an important clinical concern in chronic kidney disease (CKD), giving rise to iron-deficiency anemia and impaired cellular function. Oral supplementation, in particular with ferrous salts, is associated with a high rate of ... ...

    Abstract Iron deficiency is an important clinical concern in chronic kidney disease (CKD), giving rise to iron-deficiency anemia and impaired cellular function. Oral supplementation, in particular with ferrous salts, is associated with a high rate of gastrointestinal side effects and is poorly absorbed, a problem that is avoided with intravenous iron. The most stable intravenous iron complexes (eg, iron dextran, ferric carboxymaltose, ferumoxytol, and iron isomaltoside 1000) can be given in higher single doses and more rapidly than less stable preparations (eg, sodium ferric gluconate). Iron complexes that contain dextran or dextran-derived ligands can cause dextran-induced anaphylactic reactions, which cannot occur with dextran-free preparations such as ferric carboxymaltose and iron sucrose. Test doses are advisable for conventional dextran-containing compounds. Iron supplementation is recommended for all CKD patients with anemia who receive erythropoiesis-stimulating agents, whether or not they require dialysis. Intravenous iron is the preferred route of administration in hemodialysis patients, with randomized trials showing a significantly greater increase in hemoglobin levels for intravenous versus oral iron and a low rate of treatment-related adverse events. In the nondialysis CKD population, the erythropoietic response is also significantly higher using intravenous versus oral iron, and tolerability is at least as good. Moreover, in some nondialysis patients intravenous iron supplementation can avoid, or at least delay, the need for erythropoiesis-stimulating agents. In conclusion, we now have the ability to achieve iron replenishment rapidly and conveniently in dialysis-dependent and nondialysis-dependent CKD patients without compromising safety.
    Keywords Diseases of the genitourinary system. Urology ; RC870-923 ; Specialties of internal medicine ; RC581-951 ; Internal medicine ; RC31-1245 ; Medicine ; R ; DOAJ:Urology ; DOAJ:Medicine (General) ; DOAJ:Health Sciences
    Subject code 610
    Language English
    Publishing date 2013-01-01T00:00:00Z
    Publisher Iranian Society of Nephrology
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  4. Article ; Online: Questions and answers on iron deficiency treatment selection and the use of intravenous iron in routine clinical practice

    Toby Richards / Christian Breymann / Matthew J. Brookes / Stefan Lindgren / Iain C. Macdougall / Lawrence P. McMahon / Malcolm G. Munro / Elizabeta Nemeth / Giuseppe M. C. Rosano / Ingolf Schiefke / Günter Weiss

    Annals of Medicine, Vol 53, Iss 1, Pp 274-

    2021  Volume 285

    Abstract: AbstractIron deficiency is a common cause of morbidity and can arise as a consequence or complication from many diseases. The use of intravenous iron has increased significantly in the last decade, but concerns remain about indications and administration. ...

    Abstract AbstractIron deficiency is a common cause of morbidity and can arise as a consequence or complication from many diseases. The use of intravenous iron has increased significantly in the last decade, but concerns remain about indications and administration. Modern intravenous iron preparations can facilitate rapid iron repletion in one or two doses, both for absolute iron deficiency and, in the presence of inflammation, functional iron deficiency, where oral iron therapy is ineffective or has not worked. A multidisciplinary team of experts experienced in iron deficiency undertook a consensus review to support healthcare professionals with practical advice on managing iron deficiency in gastrointestinal, renal and cardiac disease, as well as; pregnancy, heavy menstrual bleeding, and surgery. We explain how intravenous iron may work where oral iron has not. We provide context on how and when intravenous iron should be administered, and informed opinion on potential benefits balanced with potential side-effects. We propose how intravenous iron side-effects can be anticipated in terms of what they may be and when they may occur. The aim of this consensus is to provide a practical basis for educating and preparing staff and patients on when and how iron infusions can be administered safely and efficiently.Key messagesIron deficiency treatment selection is driven by several factors, including the presence of inflammation, the time available for iron replenishment, and the anticipated risk of side-effects or intolerance.Intravenous iron preparations are indicated for the treatment of iron deficiency when oral preparations are ineffective or cannot be used, and therefore have applicability in a wide range of clinical contexts, including chronic inflammatory conditions, perioperative settings, and disorders associated with chronic blood loss.Adverse events occurring with intravenous iron can be anticipated according to when they typically occur, which provides a basis for educating and preparing staff and patients on how ...
    Keywords Anaemia ; iron-deficiency ; cardiovascular diseases ; erythrocyte transfusion ; inflammatory bowel diseases ; infusions ; Medicine ; R
    Subject code 610
    Language English
    Publishing date 2021-01-01T00:00:00Z
    Publisher Taylor & Francis Group
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  5. Article ; Online: Long-term pulse wave velocity outcomes with aerobic and resistance training in kidney transplant recipients - A pilot randomised controlled trial.

    Ellen M O'Connor / Pelagia Koufaki / Thomas H Mercer / Herolin Lindup / Eilish Nugent / David Goldsmith / Iain C Macdougall / Sharlene A Greenwood

    PLoS ONE, Vol 12, Iss 2, p e

    2017  Volume 0171063

    Abstract: BACKGROUND:This pilot study examined long-term pulse wave velocity (PWV) and peak oxygen uptake (VO2peak) outcomes following a 12-week moderate-intensity aerobic or resistance training programme in kidney transplant recipients. METHOD:Single-blind, bi- ... ...

    Abstract BACKGROUND:This pilot study examined long-term pulse wave velocity (PWV) and peak oxygen uptake (VO2peak) outcomes following a 12-week moderate-intensity aerobic or resistance training programme in kidney transplant recipients. METHOD:Single-blind, bi-centre randomised controlled parallel trial. 42 out of 60 participants completed a 9-month follow-up assessment (Aerobic training = 12, Resistance training = 10 and usual care = 20). Participants completed 12 weeks of twice-weekly supervised aerobic or resistance training. Following the 12-week exercise intervention, participants were transitioned to self-managed community exercise activity using motivational interviewing techniques. Usual care participants received usual encouragement for physical activity during routine clinical appointments in the transplant clinic. PWV, VO2peak, blood pressure and body weight were assessed at 12 weeks and 12 months, and compared to baseline. RESULTS:ANCOVA analysis, covarying for baseline values, age, and length of time on dialysis pre-transplantation, revealed a significant mean between-group difference in PWV of -1.30 m/sec (95%CI -2.44 to -0.17, p = 0.03) between resistance training and usual care groups. When comparing the aerobic training and usual care groups at 9-month follow-up, there was a mean difference of -1.05 m/sec (95%CI -2.11 to 0.017, p = 0.05). A significant mean between-group difference in relative VO2peak values of 2.2 ml/kg/min (95% CI 0.37 to 4.03, p = 0.02) when comparing aerobic training with usual care was revealed. There was no significant between group differences in body weight or blood pressure. There were no significant adverse effects associated with the interventions. CONCLUSIONS:Significant between-group differences in 9-month follow-up PWV existed when comparing resistance exercise intervention with usual care. A long-term between-group difference in VO2peak was only evident when comparing aerobic intervention with usual care. This pilot study, with a small sample size, did not aim to elucidate mechanistic mediators related to the exercise interventions. It is however suggested that a motivational interviewing approach, combined with appropriate transition to community training programmes, could maintain the improvements gained from the 12-week exercise interventions and further research in this area is therefore warranted. TRIAL REGISTRATION:study number: ISRCTN43892586.
    Keywords Medicine ; R ; Science ; Q
    Subject code 796
    Language English
    Publishing date 2017-01-01T00:00:00Z
    Publisher Public Library of Science (PLoS)
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  6. Article ; Online: Performance of a Predictive Model for Long-Term Hemoglobin Response to Darbepoetin and Iron Administration in a Large Cohort of Hemodialysis Patients.

    Carlo Barbieri / Elena Bolzoni / Flavio Mari / Isabella Cattinelli / Francesco Bellocchio / José D Martin / Claudia Amato / Andrea Stopper / Emanuele Gatti / Iain C Macdougall / Stefano Stuard / Bernard Canaud

    PLoS ONE, Vol 11, Iss 3, p e

    2016  Volume 0148938

    Abstract: Anemia management, based on erythropoiesis stimulating agents (ESA) and iron supplementation, has become an increasingly challenging problem in hemodialysis patients. Maintaining hemodialysis patients within narrow hemoglobin targets, preventing cycling ... ...

    Abstract Anemia management, based on erythropoiesis stimulating agents (ESA) and iron supplementation, has become an increasingly challenging problem in hemodialysis patients. Maintaining hemodialysis patients within narrow hemoglobin targets, preventing cycling outside target, and reducing ESA dosing to prevent adverse outcomes requires considerable attention from caregivers. Anticipation of the long-term response (i.e. at 3 months) to the ESA/iron therapy would be of fundamental importance for planning a successful treatment strategy. To this end, we developed a predictive model designed to support decision-making regarding anemia management in hemodialysis (HD) patients treated in center. An Artificial Neural Network (ANN) algorithm for predicting hemoglobin concentrations three months into the future was developed and evaluated in a retrospective study on a sample population of 1558 HD patients treated with intravenous (IV) darbepoetin alfa, and IV iron (sucrose or gluconate). Model inputs were the last 90 days of patients' medical history and the subsequent 90 days of darbepoetin/iron prescription. Our model was able to predict individual variation of hemoglobin concentration 3 months in the future with a Mean Absolute Error (MAE) of 0.75 g/dL. Error analysis showed a narrow Gaussian distribution centered in 0 g/dL; a root cause analysis identified intercurrent and/or unpredictable events associated with hospitalization, blood transfusion, and laboratory error or misreported hemoglobin values as the main reasons for large discrepancy between predicted versus observed hemoglobin values. Our ANN predictive model offers a simple and reliable tool applicable in daily clinical practice for predicting the long-term response to ESA/iron therapy of HD patients.
    Keywords Medicine ; R ; Science ; Q
    Subject code 610
    Language English
    Publishing date 2016-01-01T00:00:00Z
    Publisher Public Library of Science (PLoS)
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  7. Article ; Online: Hepcidin Response to Iron Therapy in Patients with Non-Dialysis Dependent CKD

    Carlo A Gaillard / Andreas H Bock / Fernando Carrera / Kai-Uwe Eckardt / David B Van Wyck / Sukhvinder S Bansal / Maureen Cronin / Yvonne Meier / Sylvain Larroque / Simon D Roger / Iain C Macdougall

    PLoS ONE, Vol 11, Iss 6, p e

    An Analysis of the FIND-CKD Trial.

    2016  Volume 0157063

    Abstract: Hepcidin is the key regulator of iron homeostasis but data are limited regarding its temporal response to iron therapy, and response to intravenous versus oral iron. In the 56-week, open-label, multicenter, prospective, randomized FIND-CKD study, 626 ... ...

    Abstract Hepcidin is the key regulator of iron homeostasis but data are limited regarding its temporal response to iron therapy, and response to intravenous versus oral iron. In the 56-week, open-label, multicenter, prospective, randomized FIND-CKD study, 626 anemic patients with non-dialysis dependent chronic kidney disease (ND-CKD) and iron deficiency not receiving an erythropoiesis stimulating agent were randomized (1:1:2) to intravenous ferric carboxymaltose (FCM), targeting higher (400-600μg/L) or lower (100-200μg/L) ferritin, or to oral iron. Serum hepcidin levels were measured centrally in a subset of 61 patients. Mean (SD) baseline hepcidin level was 4.0(3.5), 7.3(6.4) and 6.5(5.6) ng/mL in the high ferritin FCM (n = 17), low ferritin FCM (n = 16) and oral iron group (n = 28). The mean (SD) endpoint value (i.e. the last post-baseline value) was 26.0(9.1),15.7(7.7) and 16.3(11.0) ng/mL, respectively. The increase in hepcidin from baseline was significantly smaller with low ferritin FCM or oral iron vs high ferritin FCM at all time points up to week 52. Significant correlations were found between absolute hepcidin and ferritin values (r = 0.65, p<0.001) and between final post-baseline increases in both parameters (r = 0.70, p<0.001). The increase in hepcidin levels over the 12-month study generally mirrored the cumulative iron dose in each group. Hepcidin and transferrin saturation (TSAT) absolute values showed no correlation, although there was an association between final post-baseline increases (r = 0.42, p<0.001). Absolute values (r = 0.36, p = 0.004) and final post-baseline increases of hepcidin and hemoglobin (p = 0.30, p = 0.030) correlated weakly. Baseline hepcidin levels were not predictive of a hematopoietic response to iron therapy. In conclusion, hepcidin levels rose in response to either intravenous or oral iron therapy, but the speed and extent of the rise was greatest with intravenous iron targeting a higher ferritin level. However neither the baseline level nor the change in hepcidin was ...
    Keywords Medicine ; R ; Science ; Q
    Subject code 610
    Language English
    Publishing date 2016-01-01T00:00:00Z
    Publisher Public Library of Science (PLoS)
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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