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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
78
The patients will be randomized for the initial suspension of norepinephrine (norepinephrine group).
The patients will be randomized for the initial suspension of vasopressin (vasopressin group).
Hospital Nossa Senhora da Conceicao
Porto Alegre, Rio Grande do Sul, Brazil
Incidence of hypotension
Evaluation of the incidence of hypotension in the first 24 hours after discontinuation of one of the vasoactive drugs: norepinephrine or vasopressin. It is defined as hypotension the drop in mean blood pressure below 65 mmHg, triggering one or more of the following measures: a) administration of crystalloid or colloid aliquot, b) dose increase of the remaining vasoactive drug or c) re-establishment of the drug vasoactive paused.
Time frame: The first 24 hours after the start of reduction of one of the vasopressors.
Mortality
Evaluation of the mortality in first 28 days after discontinuation of one of the vasoactive drugs.
Time frame: Mortality in a 28-day follow-up, from the beginning of the reduction of one of the vasopressors.
Length of stay in intensive care unit
Evaluation of the length of stay in intensive care unit.
Time frame: In a 28-day follow-up, from the beginning of reduction of one of the vasopressors.
Time of use of the vasoactive drugs
Quantify the time spent using vasoactive drugs after the removal of the first drug (norepinephrine or vasopressin) in days.
Time frame: Follow-up of up to 7 days, from the beginning of reduction of one of the vasopressors.
Incidence of arrhythmias
Quantify the incidence of arrhythmias with hemodynamic repercussions in 24 hours after withdrawal of the first drug (norepinephrine or vasopressin). This group includes events in which hemodynamic worsening required electrical or chemical cardioversion.
Time frame: The first 24 hours after the start of reduction of one of the vasopressors.
Incidence of hemodialysis
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Quantify the incidence of hemodialysis, independent of dialysis modality, excluding patients on dialysis chronic.
Time frame: The first 72 hours after the start of reduction of one of the vasopressors.