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Hypotension in the Weaning From Vasopressor Drugs

Primary Purpose

Septic Shock

Status
Recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Norepinephrine
Vasopressin
Sponsored by
Hospital Nossa Senhora da Conceicao
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Septic Shock focused on measuring vasoconstrictor agents, sepsis, critical care

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Hospital Nossa Senhora da ConceicaoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

norepinephrine group

vasopressin group

Arm Description

Initial suspension of norepinephrine.

Initial suspension of vasopressin.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Mortality
Evaluation of the mortality in first 28 days after discontinuation of one of the vasoactive drugs.
Length of stay in intensive care unit
Evaluation of the length of stay in intensive care unit.
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.
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.
Incidence of hemodialysis
Quantify the incidence of hemodialysis, independent of dialysis modality, excluding patients on dialysis chronic.

Full Information

First Posted
July 25, 2022
Last Updated
August 16, 2022
Sponsor
Hospital Nossa Senhora da Conceicao
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1. Study Identification

Unique Protocol Identification Number
NCT05506319
Brief Title
Hypotension in the Weaning From Vasopressor Drugs
Official Title
Incidence of Hypotension in the Weaning From Vasopressor Drugs
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 4, 2022 (Actual)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital Nossa Senhora da Conceicao

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Septic Shock
Keywords
vasoconstrictor agents, sepsis, critical care

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A randomized, parallel, open-case clinical trial.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
78 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
norepinephrine group
Arm Type
Experimental
Arm Description
Initial suspension of norepinephrine.
Arm Title
vasopressin group
Arm Type
Experimental
Arm Description
Initial suspension of vasopressin.
Intervention Type
Other
Intervention Name(s)
Norepinephrine
Intervention Description
The patients will be randomized for the initial suspension of norepinephrine (norepinephrine group). Interruption means suspension for at least 24 hours.
Intervention Type
Other
Intervention Name(s)
Vasopressin
Intervention Description
The patients will be randomized for the initial suspension of vasopressin (vasopressin group). Interruption means suspension for at least 24 hours.
Primary Outcome Measure Information:
Title
Incidence of hypotension
Description
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.
Time Frame
The first 24 hours after the start of reduction of one of the vasopressors.
Secondary Outcome Measure Information:
Title
Mortality
Description
Evaluation of the mortality in first 28 days after discontinuation of one of the vasoactive drugs.
Time Frame
Mortality in a 28-day follow-up, from the beginning of the reduction of one of the vasopressors.
Title
Length of stay in intensive care unit
Description
Evaluation of the 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.
Title
Time of use of the vasoactive drugs
Description
Quantify the time spent using vasoactive drugs after the removal of the first drug (norepinephrine or vasopressin) in days.
Time Frame
Follow-up of up to 7 days, from the beginning of reduction of one of the vasopressors.
Title
Incidence of arrhythmias
Description
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.
Time Frame
The first 24 hours after the start of reduction of one of the vasopressors.
Title
Incidence of hemodialysis
Description
Quantify the incidence of hemodialysis, independent of dialysis modality, excluding patients on dialysis chronic.
Time Frame
The first 72 hours after the start of reduction of one of the vasopressors.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cassio Mallmann, MD
Phone
55 51 997284427
Email
casmallmann@yahoo.com.br
First Name & Middle Initial & Last Name or Official Title & Degree
Daniela M Wilhelms
Phone
55 51 33572714
Email
cep-ghc@ghc.com.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cassio Mallmann, MD
Organizational Affiliation
casmallmann@yahoo.com.br
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Nossa Senhora da Conceicao
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
91350-200
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cassio Mallmann, MD
Phone
55 51 997284427
Email
casmallmann@yahoo.com.br
First Name & Middle Initial & Last Name & Degree
Daniela M Wilhelms
Phone
55 51 3357.2714
Email
cep-ghc@ghc.com.br

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
11529214
Citation
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Results Reference
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Citation
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Results Reference
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Citation
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31958982
Citation
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Citation
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Citation
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Links:
URL
http://seer.ufrgs.br/hcpa/article/view/109542
Description
Borges RB, et al. Power and Sample Size for Health Researchers: uma ferramenta para cálculo de tamanho amostral e poder do teste voltado a pesquisadores da área da saúde.

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Hypotension in the Weaning From Vasopressor Drugs

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