Clinical trial NCT05506319: Hypotension in the Weaning From Vasopressor Drugs
Official title: Incidence of Hypotension in the Weaning From Vasopressor Drugs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Septic Shock
Keywords: vasoconstrictor agents
sepsis
critical care
vasopressin
Lead sponsor: Hospital Nossa Senhora da Conceicao
Sponsor class: OTHER
First posted: 2022-08-18
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized, parallel, open-case clinical trial.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of hypotension
timeFrame: The first 24 hours after the start of reduction of one of the vasopressors.
Secondary outcomes:
measure: Mortality
timeFrame: Mortality in a 28-day follow-up, from the beginning of the reduction of one of the vasopressors.
measure: Length of stay in intensive care unit
timeFrame: In a 28-day follow-up, from the beginning of reduction of one of the vasopressors.
measure: Time of use of the vasoactive drugs
timeFrame: Follow-up of up to 7 days, from the beginning of reduction of one of the vasopressors.
measure: Incidence of arrhythmias
timeFrame: The first 24 hours after the start of reduction of one of the vasopressors.
measure: Incidence of hemodialysis
timeFrame: The first 72 hours after the start of reduction of one of the vasopressors.
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital Nossa Senhora da Conceicao
state: RS
Study officials:
affiliation: casmallmann@yahoo.com.br
name: Cassio Mallmann, MD
role: PRINCIPAL_INVESTIGATOR
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