Risk of infection associated with intravenous iron preparations: protocol for updating a systematic review

Shah, Akshay; Sugavanam, Anita; Reid, Jack; Palmer, Antony; Dickson, Edward; Brunskill, Susan J; Dorée, Carolyn; Oliver, Charles M.; Acheson, Austin G; Baikady, R. R.; Bampoe, Sohail; Litton, Edward; Stanworth, Simon

doi:10.1136/bmjopen-2018-024618

Cited by 3 publications

(3 citation statements)

References 13 publications

(24 reference statements)

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“…This report was prepared according to the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) reporting guideline. The study protocol was registered with PROSPERO (CRD42018096023) and has been published previously …”

Section: Methodsmentioning

confidence: 99%

Risk of Infection Associated With Administration of Intravenous Iron

et al. 2021

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IMPORTANCEIntravenous iron is recommended by many clinical guidelines based largely on its effectiveness in reducing anemia. However, the association with important safety outcomes, such as infection, remains uncertain. OBJECTIVE To examine the risk of infection associated with intravenous iron compared with oral iron or no iron. DATA SOURCES Medline, Embase, and Cochrane Central Register of Controlled Trials (CENTRAL) were searched for randomized clinical trials (RCTs) from 1966 to January 31, 2021. Ongoing trials were sought from ClinicalTrials.gov, CENTRAL, and the World Health Organization International Clinical Trials Search Registry Platform. STUDY SELECTION Pairs of reviewers identified RCTs that compared intravenous iron with oral iron or no iron across all patient populations, excluding healthy volunteers. Nonrandomized studies published since January 1, 2007, were also included. A total of 312 full-text articles were assessed for eligibility. DATA EXTRACTION AND SYNTHESIS Data extraction and risk of bias assessments were performed according to the Preferred Reporting Items of Systematic Reviews and Meta-analyses (PRISMA) and Cochrane recommendations, and the quality of evidence was assessed using the GRADE (Grades of Recommendation, Assessment, Development, and Evaluation) approach. Two reviewers extracted data independently. A random-effects model was used to synthesize data from RCTs. A narrative synthesis was performed to characterize the reporting of infection. MAIN OUTCOMES AND MEASURESThe primary outcome was risk of infection. Secondary outcomes included mortality, hospital length of stay, and changes in hemoglobin and red blood cell transfusion requirements. Measures of association were reported as risk ratios (RRs) or mean differences.RESULTS A total of 154 RCTs (32 920 participants) were included in the main analysis. Intravenous iron was associated with an increased risk of infection when compared with oral iron or no iron (RR, 1.17; 95% CI, 1.04-1.31; I 2 = 37%; moderate certainty of evidence). Intravenous iron also was associated with an increase in hemoglobin (mean difference, 0.57 g/dL; 95% CI, 0.50-0.64 g/dL; I 2 = 94%) and a reduction in the risk of requiring a red blood cell transfusion (RR, 0.93; 95% CI, 0.76-0.89; I 2 = 15%) when compared with oral iron or no iron. There was no evidence of an effect on mortality or hospital length of stay. (continued) Key Points Question In patients who require treatment with intravenous iron, what is the evidence that this intervention increases the risk of developing a new infection? Findings In this systematic review and meta-analysis of 154 randomized clinical trials that included 32 920 participants, intravenous iron was associated with an increased risk of infection. Meaning The results of this study suggest that, despite broad advocacy in clinical guidelines, intravenous iron may increase the risk of infection, which must be balanced with the potential benefits of treating anemia and reducing blood transfusion requirements.

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Section: Methodsmentioning

confidence: 99%

Risk of Infection Associated With Administration of Intravenous Iron

et al. 2021

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“…There is no consensus on the peri-operative management of anaemic emergency surgery patients, for instance with treatments such as iron and erythropoietin, although haematinics are recommended by some expert panels [11,12]. There is an uncertain effect of iron infusions on infection, although red blood cell transfusion is associated with harm [31][32][33][34]. Newer markers of iron status, such as hepcidin, may help predict which patients will respond to intravenous (i.v.)…”

Section: Discussionmentioning

confidence: 99%

The association of pre‐operative anaemia with morbidity and mortality after emergency laparotomy

et al. 2020

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Summary Pre‐operative anaemia is associated with poor outcomes after elective surgery but its relationship with outcomes after emergency surgery is unclear. We analysed National Emergency Laparotomy Audit data from 1 December 2013 to 30 November 2017, excluding laparotomy for haemorrhage. Anaemia was classified as ‘mild’ 129–110 g.l−1; ‘moderate’ 109–80 g.l−1; or ‘severe’ ≤ 79 g.l−1. The primary outcome was 90‐day mortality. Secondary outcomes were 30‐day mortality, return to theatre and postoperative hospital stay. The primary outcome was available for 86,763 patients, of whom 45,306 (52%) were anaemic. There were 12,667 (15%) deaths at 90 postoperative days and 9246 (11%) deaths at 30 postoperative days. Anaemia was associated with increased 90‐day and 30‐day mortality, odds ratio (95%CI): mild, 1.15 (1.09–1.21); moderate, 1.44 (1.36–1.52); and severe, 1.42 (1.24–1.63), p < 0.001 for all; mild, 1.07 (1.00–1.12), p = 0.030; moderate, 1.30 (1.21–1.38), p < 0.001; and severe, 1.22 (1.05–1.43), p = 0.010, respectively. All categories of anaemia were associated with prolonged hospital stay, adjusted coefficient (95%CI): mild, 1.31 (1.01–1.62); moderate, 3.41 (3.04–3.77); severe, 2.80 (1.83–3.77), p < 0.001 for all. Moderate and severe anaemia were associated with increased risk of return to the operating theatre, odds ratio (95%CI): moderate 1.13 (1.06–1.21), p < 0.001; and severe 1.23 (1.06–1.43), p = 0.006. Pre‐operative anaemia is common in patients undergoing emergency laparotomy and is associated with increased postoperative mortality and morbidity.

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“…73,74,75 A new systematic review and meta-analysis is being performed to specifically address this question. 76 However, it is questionable whether this will resolve the question, since the populations studied by Pasricha et al 64 are not going to be similar to those in RCT of IV iron in the Western world.…”

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confidence: 99%

Intravenous iron: do we adequately understand the short‐ and long‐term risks in clinical practice?

Rund

2020

Br J Haematol

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Intravenous (IV) iron as a therapeutic agent is often administered but not always fully understood. The benefits of IV iron are well proven in many fields, particularly in nephrology. IV iron is beneficial not only for true iron deficiency but also for iron-restricted anaemia (functional iron deficiency). Yet, the literature on intravenous iron has many inconsistencies regarding its adverse effects. Over the last several years, newer forms of iron have been developed, leading to the more regular use of iron and in larger doses. This review will summarize some of the older and newer literature regarding the differences among iron products, including the mechanisms and frequency of their adverse events (AEs). The pathway and frequency of an underrecognized adverse event (hypophosphataemia) will be discussed. Recent insights on infection risk and iron handling by macrophages are examined. Potential but presently unproven risks of iron overload due to IV iron are discussed. The impact of these on the risk:benefit ratio and dosing of intravenous iron are considered in different clinical settings, including pregnancy and cancer. IV iron is an essential component of the therapy of anaemia and understanding these issues will enable more informed treatment decisions and knowledgeable use of these drugs.

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Risk of infection associated with intravenous iron preparations: protocol for updating a systematic review

Cited by 3 publications

References 13 publications

Risk of Infection Associated With Administration of Intravenous Iron

Risk of Infection Associated With Administration of Intravenous Iron

The association of pre‐operative anaemia with morbidity and mortality after emergency laparotomy

Intravenous iron: do we adequately understand the short‐ and long‐term risks in clinical practice?

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