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NCT Number: NCT05506319

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.

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Key information

Conditions

Septic Shock Diabetes Insipidus Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Infections Inflammation Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pituitary Diseases Sepsis Shock Shock, Septic Systemic Inflammatory Response Syndrome Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital Nossa Senhora da Conceicao

Porto Alegre, Rio Grande do Sul, 91350-200, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

norepinephrine

Other

The patients will be randomized for the initial suspension of norepinephrine (norepinephrine group).

Vasopressin

Other

The patients will be randomized for the initial suspension of vasopressin (vasopressin group).

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

Hospital Nossa Senhora da Conceicao

Other

Registry information

Official study title

Incidence of Hypotension in the Weaning From Vasopressor Drugs

Acronym: RENOVA

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Aug 18, 2022
Registry last updated
Mar 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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