Hypotension in the Weaning From Vasopressor Drugs

Sponsor

Hospital Nossa Senhora da Conceicao (Other)

Overall Status

Recruiting

CT.gov ID

NCT05506319

Collaborator

(none)

Enrollment

Location

Arms

17.9

Anticipated Duration (Months)

4.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Septic Shock	Other: Norepinephrine Other: Vasopressin	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

78 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

A randomized, parallel, open-case clinical trial.A randomized, parallel, open-case clinical trial.

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Incidence of Hypotension in the Weaning From Vasopressor Drugs

Actual Study Start Date :

Apr 4, 2022

Anticipated Primary Completion Date :

Jul 1, 2023

Anticipated Study Completion Date :

Oct 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: norepinephrine group Initial suspension of norepinephrine.	Other: Norepinephrine The patients will be randomized for the initial suspension of norepinephrine (norepinephrine group). Interruption means suspension for at least 24 hours.
Experimental: vasopressin group Initial suspension of vasopressin.	Other: Vasopressin The patients will be randomized for the initial suspension of vasopressin (vasopressin group). Interruption means suspension for at least 24 hours.

Arm

Intervention/Treatment

Experimental: norepinephrine group

Initial suspension of norepinephrine.

Other: Norepinephrine

The patients will be randomized for the initial suspension of norepinephrine (norepinephrine group). Interruption means suspension for at least 24 hours.

Experimental: vasopressin group

Initial suspension of vasopressin.

Other: Vasopressin

The patients will be randomized for the initial suspension of vasopressin (vasopressin group). Interruption means suspension for at least 24 hours.

Outcome Measures

Primary Outcome Measures

Incidence of hypotension [The first 24 hours after the start of reduction of one of the vasopressors.]
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.

Secondary Outcome Measures

Mortality [Mortality in a 28-day follow-up, from the beginning of the reduction of one of the vasopressors.]
Evaluation of the mortality in first 28 days after discontinuation of one of the vasoactive drugs.
Length of stay in intensive care unit [In a 28-day follow-up, from the beginning of reduction of one of the vasopressors.]
Evaluation of the length of stay in intensive care unit.
Time of use of the vasoactive drugs [Follow-up of up to 7 days, from the beginning of reduction of one of the vasopressors.]
Quantify the time spent using vasoactive drugs after the removal of the first drug (norepinephrine or vasopressin) in days.
Incidence of arrhythmias [The first 24 hours after the start of reduction of one of the vasopressors.]
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.
Incidence of hemodialysis [The first 72 hours after the start of reduction of one of the vasopressors.]
Quantify the incidence of hemodialysis, independent of dialysis modality, excluding patients on dialysis chronic.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.