Exploration of Different Rehabilitation Routes for Sepsis Survivors with Monitoring of Health Status and Quality of Life: RehaSep Trial Protocol.

INTRODUCTION: This project addresses the important problem of sepsis sequelae resulting in frequent hospital readmissions and higher mortality rate in the post-discharge period. However, neither specific diagnostic methods nor standards for rehabilitation of sepsis patients have been introduced yet. The aim of this study is to evaluate the effectiveness of two different multiparameter-monitored rehabilitation treatments in order to improve the health status and quality of life of sepsis survivors.

METHODS: Decades of failed randomized controlled trials involving sepsis patients strongly suggest the need for a paradigm change. Therefore, we designed a prospective, interventional, controlled, pragmatic, patient-centred trial based on the principles of personalized medicine. Sixty post-sepsis patients after hospital discharge will be individually assigned to a control group (without intervention) and two groups with 3-month diagnostically monitored rehabilitation programs based either on the recumbent cycloergometer training or on the experimental hyperbaric oxygen therapy. In all of the patients a wide range of physiological (spirometry, ECG/cycloergometer exercise test), haematological (microscopy) and biochemical (blood tests) parameters will be assessed at hospital discharge and during subsequent 3 months in order to monitor changes of their physical capacity, immunity and degree of post-sepsis organ damage/recovery. For quality of life monitoring a novel tool-"Life After Sepsis Survey"-will be applied.

PLANNED OUTCOMES: A set of composite quantitative indices resulting from laboratory measurement data combined with the quality of life questionnaire data will constitute the primary outcomes whereas mortality rate and hospital readmission number will be counted as the secondary outcomes.

CONCLUSIONS: Critical analysis of past trials prompted us to implement multiple improvements in tools and procedures. The results of this trial will contribute to the development of rehabilitation therapy addressing not only weakness but also organ damage problems of sepsis survivors.

TRIAL REGISTRATION: ANZCTR ( https://www.anzctr.org.au ): ACTRN12618000347268, U1111-1210-6110.

FUNDING: This research was funded by the National Science Center, Poland.