Alteration of Informed Consent Enables Timely Collection of Preresuscitation Sample for Septic and Septic Shock Patients in the Emergency Department

Transcriptomic and proteomic research in septic populations is largely post-resuscitative given the difficulty of timely prospective informed consent (PIC). This significantly limits the ability for research to inform diagnostics development. This study assessed the utility of deferred informed consent (DIC) for sepsis-based research. DIC entails obtaining a research sample with initial clinical blood draw followed by informed consent later to use the sample.

We performed a single-center, observational blood acquisition study of patients presenting to the Emergency Department (ED) with signs of organ dysfunction and concern for bacterial infection. From December 2018 to March 2023, 155 subjects were enrolled using PIC. From March 2024 and March 2025, 97 subjects were enrolled using an institutional IRB approved alteration of informed consent, allowing DIC after blood collection. The presence of sepsis in enrolled subjects was adjudicated by a physician. Statistical analysis included Mann Whitney U and chi-squared tests to assess enrollment and cohort variables.

Seven PIC subjects and 1 DIC subject were excluded due to unavailable blood samples or clinical data. With DIC, the mean monthly enrollment increased from 3.70 ± 2.36 to 7.38 ± 4.13, p = 0.003. Research blood draw times were documented for 85 PIC subjects and 96 DIC subjects. The mean time from ED arrival to research draw was longer for PIC subjects with constitutional or baseline altered mental status (AMS) (5.70 ± 3.24 hrs) compared to those without AMS (4.38 ± 2.43 hrs), p = 0.044. After the implementation of DIC, the mean time to research draw decreased from 4.79 ± 2.80 hrs to 0.81 ± 0.68 hrs, p < 0.001. In DIC, time to draw did not differ by AMS status (0.83 ± 0.61 vs 0.73 ± 2.04 hrs; p = 0.268). An increasing trend of non-white participants was also observed between PIC (15.54%, n = 23) and DIC (23.96%, n = 23), p = 0.101. The proportion of septic/septic shock subjects was similar in PIC (52.03%, n = 77) and DIC (54.17%, n = 52), p = 0.744.

DIC facilitates increased enrollment, decreased time to research draw, and may increase participant diversity. It also allows for the inclusion of patients with AMS, a critical subgroup, into pre-resuscitation research. Overall, DIC enables transcriptomic and proteomic analysis of septic patients prior to resuscitation, the timepoint relevant to development of sepsis diagnostics.