Mark Wefers Bettink

Interim analysis; Feasibility study of measurement of mitochondrial function in patients with sepsis 7 129 The most used ex vivo technique to measure mitochondrial oxygen metabolism is an high resolution respirometer.(17) However tissue biopsies are invasive and not feasible in ICU patients and is not performed in clinical practice. Recently a strong link was shown with mortality in sepsis patients and mitochondrial dysfunction measured in platelets. (18, 19) Furthermore measuring a high concentration of mitochondrial DNA in serum, only present if mitochondrial damage occurs, is predictive for mortality.(8, 9) Measuring in vivo mitochondrial dysfunction in ICU patients with the COMET monitor when ex vivo tests show altered mitochondrial function or damage could provide the first signal for a higher risk for mortality in patients at bedside. The primary goal of this study was to evaluate the ability of the COMET monitor to measure mitoPO 2 and mitoVO 2 concentrations reliably in ICU patients. No prior data was available on the use of the COMET monitor in a real-life ICU setting. Secondary goals of this pilot study were to determine changes in mitoPO 2 and mitoVO 2 concentrations in sepsis patients on the first day of admission compared to measurements in ICU-admitted control patients. Moreover, COMET’s measurements were compared to mitochondrial respiration in platelets and the concentration of mitochondrial DNA as measured in plasma. Materials and methods Subjects For this study, adult patients between 18 and 70 years of age were recruited from the intensive care unit (ICU; maximum capacity of 36 staffed beds) of the Erasmus MC University Medical Center Rotterdam, which is the largest tertiary hospital in The Netherlands. Every morning all newly ICU-admitted patients were screened by the researcher or ICU research nurse. The study protocols received institutional research board approval (MEC-2016-540). The protocol was registered at toetsingonline.nl as NL65767.078.18. If possible, written and signed informed consent was obtained from the patient before the beginning of the study. Due to the ICU setting, even patients who were able to communicate, were often unable to determine for themselves if they were willing and able to participate in this study. Even if legal representatives are available at the time of inclusion, an informed consent conversation could be an unsolicited and avoidable burden at this point. However, the aim of this study was to measure mitochondrial changes in an developing sepsis and therefore created a need to prepare the measurement as soon as possible. So, considering the minimal risk of this study,