Recombinant human brain natriuretic peptide for the recovery stage of septic shock: an interventional study protocol

In the de-resuscitation phase of septic shock, resolving vasoplegia and fluid mobilisation can increase venous congestion in patients with sepsis-related myocardial dysfunction. This study will characterise the haemodynamic effects and safety of recombinant human brain natriuretic peptide (rh-BNP) in this population.

This single-centre, prospective, single-arm study will enrol 30 adults recovering from septic shock with improving infection/vasopressor trends, sinus rhythm, ongoing pulse-index continuous cardiac output (PiCCO) monitoring and measurable arm-equilibrium pressure (Parm). Eligibility will require cardiac dysfunction (left-ventricular ejection fraction ≤50% and/or ≥10% absolute decline when available) and volume overload (global end-diastolic volume index >800 mL/m² and extravascular lung water index >10 mL/kg). Participants will receive rh-BNP (2 µg/kg intravenous bolus over 15 min, then a 0.01 µg/kg/min infusion for up to 72 hours). Measurements will be obtained at baseline, acute response (30-60 min), 24, 48 and 72 hours. The primary outcome will be within-patient change in venous return pressure gradient (ΔPVR, Parm-central venous pressure) from baseline to acute response. Secondary outcomes will include indices of preload, cardiac function, tissue perfusion and venous congestion. Haemodynamic instability will be the safety endpoint. Paired tests and repeated-measures analyses will estimate within-patient changes over time.

Ethics approval has been obtained from the Ethics Committee of Sichuan Provincial People's Hospital, Sichuan Academy of Medical Sciences (No. 2024-653-1). Written informed consent will be obtained. Findings will be disseminated via peer-reviewed publications and conferences.

NCT06745206.