Rationale and Design of the MIA Trial: A Proof-of-Concept Study of Minimally Invasive Autopsy in an Infectious Cause of Death in a Scandinavian ICU Setting.

It remains a challenge to obtain well-preserved tissue samples from deceased patients as access to regular autopsy is limited. Minimally invasive autopsy (MIA) is a potential alternative to the complete diagnostic autopsy because of its efficacy in providing non-autolyzed tissue samples and its increased acceptability amongst the bereaved. The study follows an exploratory, prospective design without any kind of intervention. Inclusion criteria are deceased adults (≥ 18 years), confirmed signs of death, uncertain or multifactorial cause of death, present or previous infection, and permission from next of kin to perform MIA, defined by ultrasound (US)-guided samples from the heart, lungs, liver, spleen, and kidneys using a TruCut semi-automatic coaxial needle (14G; 16 cm length). Tissue samples, fixed in BiopSafe 20 mL formalin test tubes, are sent for pathological evaluation. The primary outcome is the achievement of well-preserved tissue samples, representative of the target organ and suitable for histopathological evaluation and diagnosis. An exploratory outcome is to establish the degree of clinico-pathological discrepancies between pre-mortem clinical status and post-mortem pathological descriptions. This investigator-initiated study is designed to validate the feasibility of MIA to enable fast-track post-mortem evaluation in an ICU environment.