Hypotension in the Weaning From Vasopressor Drugs

Phase 4

Completed

• Conditions: Septic Shock
• Interventions: Other: Norepinephrine; Other: Vasopressin

• Registration Number: NCT05506319
• Lead Sponsor: Hospital Nossa Senhora da Conceicao

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.

Study Timeline

• Study Start: 2022-05-01
• Study First Submitted: 2022-07-25
• Study First Submitted QC: 2022-08-16
• Study First Posted: 2022-08-18
• Primary Completion: 2022-12-01
• Study Completion: 2023-06-30
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-11
• Last Update Posted: 2025-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
norepinephrine group	Norepinephrine	Initial suspension of norepinephrine.
vasopressin group	Vasopressin	Initial suspension of vasopressin.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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.
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.

Trial Locations

Locations (1)

Hospital Nossa Senhora da Conceicao; 🇧🇷 Porto Alegre, RS, Brazil