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Original article
Available online 31 January 2025
Reduction of norepinephrine versus vasopressin in the stabilization phase of septic shock: RENOVA clinical trial
Reducción de noradrenalina frente a vasopresina en la fase de estabilización del shock séptico: ensayo clínico RENOVA
Cássio Mallmanna,b,&#¿;
Corresponding author
casmallmann@yahoo.com.br

Corresponding author.
, Thizá Maria Bianchi Galiottoc, Michele Salibe de Oliveirab, Rafael Barberena Moraesa,c,d
a Postgraduate Program in Pulmonary Sciences, Federal University of Rio Grande do Sul, Porto Alegre, Brazil
b Intensive Care Unit, Nossa Senhora da Conceição Hospital, Conceição Hospital Group, Porto Alegre, Brazil
c Intensive Care Unit, Fêmina Hospital, Conceição Hospital Group, Porto Alegre, Brazil
d Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil
Received 11 September 2024. Accepted 25 November 2024
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Table 1. Population characteristics.
Table 2. Outcomes.
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Abstract
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 (NCT 05506319).

Keywords:
Shock
Hypotension
Sepsis
Vasoconstrictors
Norepinephrine
Vasopressin
Abbreviations:
RCT
SOFA
AIDS
COPD
PaO2/FiO2 ratio
Resumen
Objetivo

Evaluar la incidencia de hipotensión en la fase de retirada de vasopresores: noradrenalina y vasopresina.

Diseño

Ensayo clínico unicéntrico, abierto y aleatorizado.

Ámbito

un Hospital Universitario de tercer nível.

Pacientes

91 pacientes mayores de 18 años con shock séptico (según Sepsis-3).

Intervención

Los pacientes se dividieron en dos grupos: reducción inicial de noradrenalina o reducción inicial de vasopresina.

Principales variables de interés

La incidencia de hipotensión en las primeras 24 horas posteriores a la reducción de vasopresores. El impacto clínico de esta hipotensión a través de la mortalidad, la duración de la estancia hospitalaria, el tiempo con vasopresor, la incidencia de arritmias y la prevalencia de hemodiálisis.

Resultados

De 91 pacientes, 78 fueron incluidos en el análisis: 39 en el grupo noradrenalina y 39 en el grupo vasopresina. La incidencia de hipotensión fue mayor en el grupo que inició la retirada de noradrenalina (43,6% vs 25,6%), aunque no hubo diferencias estadísticamente significativas (p&#¿;=&#¿;0,153, RR = 1,7, IC 95%: 0,9−3,2). En esta muestra, la retirada de vasopresina se tituló en la mayoría de los casos. No hubo diferencias entre los grupos en cuanto a los resultados clínicos evaluados.

Conclusión

No se detectaron diferencias en la incidencia de hipotensión cuando el destete se inició con norepinefrina o vasopresina, aunque fue no significativamente mayor en el grupo de norepinefrina. En nuestra muestra, la vasopresina se retiró de forma titulada, lo que refleja la realidad nacional, lo que difiere de la práctica norteamericana.

Registro Brasileño de Ensayos Clínicos (REBEC: RBR-10smbw65).

Plataforma ClinicalTrials.gov (NCT 05506319).

Palabras clave:
Shock
Hipotensión
Septicemia
Vasoconstrictores
Noradrenalina
Vasopresina

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