Weaning Approaches for Vasopressin in Sepsis
ConditionSeptic Shock
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorHospital Nossa Senhora da Conceicao
About this trial
In this study, we aim to evaluate the incidence of hypotension during vasopressin weaning by comparing two methods - titrated reduction versus abrupt withdrawal - through the conduct of a randomized clinical trial.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age over 18 years
Admitted to the Intensive Care Unit
Patients with vasopressor dependent sepsis
Receiving combined norepinephrine and vasopressin therapy
Disqualifiers
Withdrawal/reduction of vasopressin related to a plan of treatment limitation or palliative care
Withdrawal/reduction of vasopressin associated with the initiation of adrenaline or any other vasopressor
Trial design
Design model
Parallel
Treatments tested in this trial
Titrated weaning of vasopressin.
Other interventionThe titrated group will follow the vasopressin weaning protocol used in the DOVSS study (reduction of 0.01 U/min per hour).
Abrupt weaning of vasopressin.
Other interventionThe abrupt group will discontinue the vasopressin infusion at the time of randomization, without dose titration.
Treatment groups
82 Participants
are divided into 2 treatment groupsGroup A: Titrated groupExperimental treatment 1 intervention
Group B: Abrupt groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Hypotension within the first 24 hours
Incidence of hypotension with clinical repercussions within the first 24 hours after titrated reduction or abrupt withdrawal of vasopressin. Definition of hypotension with clinical repercussions: mean arterial pressure \< 60 mmHg, leading to: * administration of crystalloid/colloid bolus and/or * increase in norepinephrine dose and/or * reinitiation or increase in vasopressin dose.
Time frame
24 hoursSecondary outcomes
1
Hypotension stratified according to vasopressin duration
Incidence of hypotension with clinical repercussions within the first 24 hours after titrated reduction or abrupt withdrawal of vasopressin, stratified according to vasopressin duration: \< 48 hours ≥ 48 hours Definition of hypotension with clinical repercussions: mean arterial pressure \< 60 mmHg, leading to: * administration of crystalloid/colloid bolus and/or * increase in norepinephrine dose and/or * reinitiation or increase in vasopressin dose.
Time frame
24 hours2
Hypotension within the first hour
Incidence of hypotension with clinical repercussions within the first hour after titrated reduction or abrupt withdrawal of vasopressin. Definition of hypotension with clinical repercussions: mean arterial pressure \< 60 mmHg, leading to: * administration of crystalloid/colloid bolus and/or * increase in norepinephrine dose and/or * reinitiation or increase in vasopressin dose.
Time frame
First hour3
Vasopressor-free days
Number of days a patient is alive and free of vasopressor between randomization and day 7. Non-survivors will be considered to have zero vasopressor-free days.
Time frame
7 days4
Vasopressin-free days
Number of days a patient is alive and free of vasopressin between randomization and day 7. Non-survivors will be considered to have zero vasopressin-free days.
Time frame
7 daysSponsors and contacts
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Source ClinicalTrials.gov