Hypotension in the Weaning From Vasopressor Drugs (RENOVA)

Hospital Nossa Senhora da Conceicao

Status and phase: Completed; Phase 4

Conditions: Septic Shock

Treatments: Other: Norepinephrine; Other: Vasopressin

Study type: Interventional

Funder types: Other

Identifiers

NCT05506319

57213022.0.0000.5530

Details and patient eligibility

About

Although there is consensus in the literature on hemodynamic management of septic shock in the resuscitation phase, the best way to conduct the weaning of vasopressor drugs in the stabilization phase remains open. The present study aims to study the incidence of hypotension in the weaning phase of vasopressor drugs- norepinephrine and vasopressin.

Full description

A randomized, open-case clinical trial with 2 arms will be conducted: initial suspension of norepinephrine (norepinephrine group) versus initial vasopressin (vasopressin group).

The selection of patients who will participate in the study will be for convenience. The randomization of the patients will be done by opaque envelopes 1:1, grouped into blocks, generated by random numbers.

The study will be carried out in the intensive care unit of a tertiary hospital in Southern Brazil, taking into account the clinical and surgical patients. In the intensive care unit, after randomization, patients will be identified by posters, attached to the bed. The titration of vasoactive drugs will be criterion of the assistant team.

Enrollment: 78 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with septic shock, according to the definitions of SEPSIS - 3: septic and hypotensive patients, demanding use of vasoactive drug and lactate greater than 2 mmol/L (18 mg/dL).
• Patients admitted to the intensive care unit.
• Patients in need of associated use of norepinephrine and vasopressin.

Exclusion criteria

• Patients in whom discontinuation of norepinephrine or vasopressin has been given by decision of the assistant team, from a perspective of prioritizing palliative care.
• Patients using a combination of a third drug, with the effect of predominantly vasopressor - adrenaline.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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78 participants in 2 patient groups

norepinephrine group

Experimental group

Description:

Initial suspension of norepinephrine.

Treatment:

Other: Norepinephrine

vasopressin group

Experimental group

Description:

Initial suspension of vasopressin.

Treatment:

Other: Vasopressin