Figure 1Algorithm for clinical management considering strict indication.As a final step, we give http://www.selleckchem.com/products/Abiraterone.html a list of suggestions that should be adequately considered by any planned prospective RCT in the field of acute volume resuscitation in critically ill patients in the future (Figure (Figure22).Figure 2Safety checklist for future prospective randomised controlled trials.ConclusionsAs recent RCTs show large heterogeneity in terms of ‘probably correct indication’, the most important question, whether or not HES may be harmful when it is limited to acute volume resuscitation cannot be answered yet. We suggest an algorithm emphasising the strict indication of HES for patients with hypovolaemia limited to the initial phase of volume resuscitation. Additionally, we suggest a safety checklist for future prospective RCTs.
Key messages? The safety of HES has been questioned in recent trials, although full adherence to ‘presumably correct indication’, defined by short time interval from shock to randomisation, restricted use for initial volume resuscitation, use of any consistent algorithm for haemodynamic stabilisation, reproducible indicators of hypovolaemia, maximum dose of HES, and exclusion of patients with pre-existing renal failure or RRT, could not be found in any of these trials.? The question, whether or not HES may be harmful when it is limited to immediate haemodynamic stabilisation, cannot be answered yet.? We suggest an algorithm for clinical management emphasising the strict indication of HES.
? Further, we suggest a safety checklist for future prospective randomised controlled trials that might be important in the field of acute volume resuscitation in critically ill patients.? The PRAC recommendation is viewed with concern, since it extrapolates not only from long-term use in septic patients to acute haemodynamic stabilisation in this cohort of patients but also to all licensed and not-licensed (off-label) use of HES.AbbreviationsAKI: acute kidney injury: HES, hydroxyethyl starch: ICU, intensive care unit: PRAC, Pharmacovigilance Risk Assessment Committee: RCT, randomised controlled trial: RIFLE: risk, injury, failure, loss, and end-stage renal disease: RRT, renal replacement therapy: SOFA, sequential organ failure assessment.Competing interestsPM received lectures fees from Pulsion Medical Systems and independent research grants from B.
Braun Melsungen, Fresenius Kabi, Vifor Pharma, and CSL Behring. HVA received honoraria and travel expenses from Vifor Pharma, Abbott, and Fresenius Kabi. ADG received lecture/consultancy fees from Fresenius Kabi, CSL Behring and Grifols. HG held lectures for Fresenius Kabi, CSL Behring and Vifor Pharma.BG held Cilengitide lectures for Fresenius Kabi. He received independent research grants from Fresenius Kabi. He is member of the Grifols Albumin Advisory Board.