Hypotension in the Weaning From Vasopressor Drugs

Study Overview
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Brief Summary
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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
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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.

Official Title
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Incidence of Hypotension in the Weaning From Vasopressor Drugs

Conditions
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Septic Shock

Intervention / Treatment
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* Other: Norepinephrine
* Other: Vasopressin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A randomized, parallel, open-case clinical trial.
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | The first 24 hours after the start of reduction of one of the vasopressors. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | Evaluation of the mortality in first 28 days after discontinuation of one of the vasoactive drugs. | 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. | 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. | 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. | The first 24 hours after the start of reduction of one of the vasopressors. | 
| Incidence of hemodialysis | Quantify the incidence of hemodialysis, independent of dialysis modality, excluding patients on dialysis chronic. | The first 72 hours after the start of reduction of one of the vasopressors. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vasoconstrictor agents, sepsis, critical care