Reduction of norepinephrine versus vasopressin in the stabilization phase of septic shock: RENOVA clinical trial.

Objective: Evaluate the incidence of hypotension during the weaning phase of vasopressors.

Design: A single-center, open-label randomized clinical trial between May and December 2022.

Setting: a tertiary care academic medical center.

Patients: 91 adult patients over 18 years of age with septic shock (according to Sepsis-3).

Intervention: Patients were divided into two groups: initial reduction of norepinephrine or initial reduction of vasopressin.

Main variables of interest: The primary outcome was the incidence of hypotension within the first 24 h after reducing vasopressors. Additionally, the clinical impact of this hypotension was assessed through mortality, length of hospital stay, duration of vasopressor use, incidence of arrhythmias, and prevalence of hemodialysis.

Results: Out of a total of 91 patients, 78 were included in the analysis: 39 in the norepinephrine group and 39 in the vasopressin group. Despite a numerically significant difference in the incidence of hypotension between the groups (norepinephrine 43.6%, vasopressin 25.6%), there was no statistical difference (p =  0.153, relative risk = 1.7, 95% confidence interval: 0.9-3.2). In this sample, vasopressin withdrawal was predominantly titrated. There were no differences between the groups in terms of the evaluated clinical outcomes.

Conclusion: No differences were detected in the incidence of hypotension when weaning was initiated with norepinephrine or vasopressin, although it was non significantly higher in norepinephrine group. In our sample, vasopressin withdrawal was titrated, which differs from North American practice. Brazilian Clinical Trials Registry (REBEC: RBR-10smbw65).

Clinicaltrials: gov platform (NCT05506319).