Hypotension in the Weaning From Vasopressor Drugs (RENOVA)

March 11, 2025 updated by: Hospital Nossa Senhora da Conceicao

Incidence of Hypotension in the Weaning From Vasopressor Drugs

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

78

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • RS
      • Porto Alegre, RS, Brazil, 91350-200
        • Hospital Nossa Senhora da Conceicao

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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).
Experimental: vasopressin group
Initial suspension of vasopressin.
Other: Vasopressin
The patients will be randomized for the initial suspension of vasopressin (vasopressin group).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of hypotension
Time Frame: 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.
The first 24 hours after the start of reduction of one of the vasopressors.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: 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.
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
Time Frame: 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.
In a 28-day follow-up, from the beginning of reduction of one of the vasopressors.
Time of use of the vasoactive drugs
Time Frame: 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.
Follow-up of up to 7 days, from the beginning of reduction of one of the vasopressors.
Incidence of arrhythmias
Time Frame: 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.
The first 24 hours after the start of reduction of one of the vasopressors.
Incidence of hemodialysis
Time Frame: 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.
The first 72 hours after the start of reduction of one of the vasopressors.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Nossa Senhora da Conceicao

Investigators

  • Principal Investigator: Cassio Mallmann, MD, casmallmann@yahoo.com.br

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2022

Primary Completion (Actual)

December 1, 2022

Study Completion (Actual)

June 30, 2023

Study Registration Dates

First Submitted

July 25, 2022

First Submitted That Met QC Criteria

August 16, 2022

First Posted (Actual)

August 18, 2022

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 11, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 57213022.0.0000.5530

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

It is intended to display the search results in the scientific environment in the form of an article for publication.

At the end of the research, a copy of the work will be delivered to the Documentation Centre of the Grupo Hospitalar Conceicao (study center).

IPD Sharing Time Frame

Available from November 2023.

IPD Sharing Supporting Information Type

  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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