Small volume fluid resuscitation and supplementation with 20% albumin versus buffered crystalloids in adults with septic shock: A protocol for a randomised feasibility trial.

Abstract

Background: Fluid therapy is universally administered in the management of patients with sepsis, however excessive cumulative fluid balance has been shown to result in worse outcomes. Hyperoncotic albumin results in both lower fluid volumes and early cumulative fluid balance, and may reduce short-term mortality in patients with septic shock.

Methods: In this single centre, open label, feasibility trial; patients with early septic shock will be randomly allocated either 20% albumin for resuscitation and daily supplementation, versus buffered crystalloids alone for all fluid therapy. The intervention period will last 7 days, with follow up points at ICU and hospital discharge, and 90 days after randomisation.

Objectives: Primary outcome measures including recruitment rate, intervention adherence, data completeness and safety will constitute objective evidence of feasibility, according to pre-specified thresholds. Secondary outcomes will include mortality and healthcare utilisation at 90 days, alongside other physiological and patient centred outcomes to inform the design of a future effectiveness trial.

Conclusion: This study will rigorously test the feasibility of conducting a future trial to test both the clinical and cost-effectiveness of hyperoncotic albumin in patients with early septic shock.