A Critical Reassessment of the Kidney Risk Caused by Tetrastarch Products in the Perioperative and Intensive Care Environments.

Purpose: To reassess the results of former meta-analyses focusing on the relationship between novel HES preparations (130/0.4 and 130/0.42) and acute kidney injury. Previous meta-analyses are based on studies referring to partially or fully unpublished data or data from abstracts only. Methods : The studies included in the former meta-analyses were scrutinized by the authors independently. We completed a critical analysis of the literature, including the strengths, weaknesses and modifiers of the studies when assessing products, formulations and outcomes. Results : Both the published large studies and meta-analyses show significant bias in the context of the deleterious effect of 6% 130/0.4-0.42 HES. Without (1) detailed hemodynamic data, (2) the exclusion of other nephrotoxic events and (3) a properly performed evaluation of the dose-effect relationship, the AKI-inducing property of 6% HES 130/0.4 or 0.42 should not be considered as evidence. The administration of HES is safe and effective if the recommended dose is respected. Conclusions : Our review suggests that there is questionable evidence for the deteriorating renal effect of these products. Further well-designed, randomized and controlled trials are needed. Additionally, conclusions formulated for resource-rich environments should not be extended to more resource-scarce environments without proper qualifiers provided.