This all leads to the double-edged sword of conducting large well

This all leads to the double-edged sword of conducting large well-powered clinical trials. In this respect, the 6S trial [3] is limited as data of circulatory parameters (for example, central venous oxygen saturation) were not registered in up to 67% of patients during the first 24 h, and also 3-day detailed data on fluid therapy are missing in up to 19% necessary of patients, respectively.In terms of raw data, arguments for making raw data more widely available and sharing data were once more repeated in a recent editorial in the British Medical Journal [39] to ensure independent scrutiny, testing of secondary hypotheses, aiding design of new studies, and simplifying data acquisition for meta-analyses.8. We suggest that the best quality of data documentation and adequate follow-up are mandatory in future trials.

Making raw data freely available would enable both clinicians and scientists to understand and to interpret study data more appropriately.Future perspectives – algorithm for clinical management and safety checklistThe most important question, whether or not HES may be harmful when it is limited to immediate haemodynamic stabilisation cannot be answered yet. Currently, no study is available that sufficiently addresses this question. However, the recent large-scale trials have nicely demonstrated that chronic use without proper indication and assessment may cause harm. This has been the strength of these trials and can be viewed as an important contribution to safety in the care of critically ill patients.In fact, we need additional studies focusing on acute volume resuscitation and the initial phase of haemodynamic stabilisation.

To overcome the above mentioned limitations of most of the previous trials, first, we suggest an algorithm for clinical management emphasising the strict indication of HES (Figure (Figure1).1). This algorithm starts with the strict identification of patients with hypovolaemia. From our point of view, relevant hypovolaemia is likely if at least one of the following criteria is present: positive fluid responsiveness, lactate level >3 mmol/L, central venous oxygen saturation <70%, hypotension/tachycardia, and/or oliguria. As a second step, acute volume resuscitation with HES should be limited to a time interval of less than, in general, 6 h after onset of shock, to patients without pre-existing renal failure or AKI (unless oliguria is due to hypovolaemia), Anacetrapib and to the initial phase of volume resuscitation (that should not last longer than 24 h). We acknowledge that the time interval of 6 h for starting HES might be tricky if no therapeutic intervention at all has been done, or if there are ‘ups and downs’ in the clinical course with a re-occurence of hypovolaemia.

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