Septic ShockPhase 4EVSSNCT06471231
Renal Outcomes in the Early Use of Vasopressin in the Treatment of Septic Shock
A Phase 4 study testing vasopressin infusion when the norepinephrine dosage is equal to or greater than 0.25 mcg/kg/min and vasopressin infusion when the norepinephrine dosage is equal to or greater than 0.5 mcg/kg/min in people with Septic Shock and Renal Function Replacement, run by Azienda Usl di Bologna at 1 site in Italy.
Trial summary
The aim of the present study is to verify whether the earlier association of vasopressin and norepinephrine, in patients in septic shock, determines variations in terms of use of renal function replacement techniques in the first 7 days of hospitalization in Intensive Care, compared to patients in whom vasopressin is… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Septic Shock, Renal Function Replacement
- What is being tested?
- vasopressin infusion when the norepinephrine dosage is equal to or greater than 0.25 mcg/kg/min and vasopressin infusion when the norepinephrine dosage is equal to or greater than 0.5 mcg/kg/min
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 264 participants
- Where
- 1 siteItaly
- Study dates
- 15 May 2024to 15 May 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients suffering from septic shock hospitalized in an intensive setting
- patients over 18 years and under 80 years of age
- patients within 24 hours of clinical diagnosis, and requiring, in this time window, a norepinephrine dosage equal to or greater than 0.25 mcg/kg/min according to the patient's ideal weight (IBW)
- patients capable of expressing informed consent to treatment.
Who cannot join
- patients in the absence of consent to participate in the study and to the processing of personal and particular data;
- patients under 18 years of age or over 80 years of age;
- patients who died within the first 24 hours of admission to the ICU;
- patients requiring a norepinephrine dosage lower than 0.25 mcg/kg/min in the first 24 hours of hospitalization in the ICU;
- patients with recent acute coronary syndrome (within the previous 7 days);
- patients with allergy/intolerance to the drugs used in the study or to any component of the study drug including excipients;
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- pregnant patients;
- breastfeeding individuals;
- patients who need to start renal replacement treatment within 24 hours of admission to the ICU for dialysis emergencies that cannot be deferred;
- patients with a history of end-stage renal failure or already undergoing dialysis treatment (CKD stages 4 and 5, with glomerular filtration < 30 ml/min);
- single kidney patients;
- patients with bilateral renal hypoplasia;
- patients undergoing kidney transplant;
- patients undergoing haemoperfusion with an adsorbent cartridge for bacterial endotoxin.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Azienda Unità Sanitaria Locale
Bologna, 40100
Lorenzo Giuntoli, Md, 0516478868, lorenzo.giuntoli@ausl.bologna.it
Lorenzo Giuntoli, Md
About this study
The aim of the present study is to verify whether the earlier association of vasopressin and norepinephrine, in patients in septic shock, determines variations in terms of use of renal function replacement techniques in the first 7 days of hospitalization in Intensive Care, compared to patients in whom vasopressin is added only when norepinephrine reaches a higher dose.
Read the detailed description
The aim of the present study is to verify whether the earlier association of vasopressin and norepinephrine, in patients in septic shock, determines variations in terms of use of renal function replacement techniques in the first 7 days of hospitalization in Intensive Care, compared to patients in whom vasopressin is added only when norepinephrine reaches a higher dose. The study is aimed at patients admitted to the ICU with a diagnosis of septic shock on admission or in the first 24 hours of admission.
Patients will be divided and randomized in a 1:1 ratio through a computer-generated scheme, when the dose of norepinephrine administered is ≥ 0.25 mcg/kg/min, into the following groups:
- Group A: when the norepinephrine dosage is equal to or greater than 0.25 mcg/kg/min in the absence of adequate MAP (Mean arterial pressure >65 mmhg), vasopressin infusion will be associated with the standard dosage of 0.3UI/min.
- Group B (control): the infusion of vasopressin at a dosage of 0.3 IU/min will be associated if norepinephrine exceeds the dosage of 0.5 mcg/kg/min in the absence of adequate MAP.
- Conditions
- Septic Shock, Renal Function Replacement
- Being tested
- vasopressin infusion when the norepinephrine dosage is equal to or greater than 0.25 mcg/kg/min, vasopressin infusion when the norepinephrine dosage is equal to or greater than 0.5 mcg/kg/min
- Keywords
- vasopressin, norepinephrine, renal function replacement, Septic Shock
- Medical subject headings
- Shock, Septic, Diabetes Insipidus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vasopressin infusion when the norepinephrine dosage is equal to or greater than 0.25 mcg/kg/minDrug
when the norepinephrine dosage is equal to or greater than 0.25 mcg/kg/min in the absence of adequate MAP (Mean arterial pressure >65 mmhg), vasopressin infusion will be associated with the standard dosage of 0.3UI/min.
vasopressin infusion when the norepinephrine dosage is equal to or greater than 0.5 mcg/kg/minDrug
the infusion of vasopressin at a dosage of 0.3 IU/min will be associated if norepinephrine exceeds the dosage of 0.5 mcg/kg/min in the absence of adequate MAP
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Group A: when the norepinephrine dosage is equal to or greater than 0.25 mcg/kg/min in the absence of adequate MAP (Mean arterial pressure >65 mmhg), vasopressin infusion will be associated with the standard dosage of 0.3UI/min. Receives: Drug: vasopressin infusion when the norepinephrine dosage is equal to or greater than 0.25 mcg/kg/min |
| Group B | Active comparator | Group B (control): the infusion of vasopressin at a dosage of 0.3 IU/min will be associated if norepinephrine exceeds the dosage of 0.5 mcg/kg/min in the absence of adequate MAP. Receives: Drug: vasopressin infusion when the norepinephrine dosage is equal to or greater than 0.5 mcg/kg/min |
What is being measured
The primary outcome is the main question the study is designed to answer.
30% or more reduction in terms of the use of renal function replacement
The primary objective of the study is to verify whether the earlier association of vasopressin and norepinephrine determines a 30% or more reduction in terms of the use of renal function replacement techniques in the first 7 days of hospitalization in the Intensive Care Unit (ICU), compared to patients in whom the vasopressin is added only when norepinephrine reaches a higher dosage.
Measured: 7 days
Secondary outcomes (8)
early association of vasopressin improves renal function
To assess the protective effect of early vasopressin association, the Kidigo score will be calculated for every subject at enrollment time, and daily, for 7 days. The maximum value and the greatest increase will be evaluated and compared between study and control group
Measured: 7 days
rly addition of vasopressin modifies renal perfusion
verify whether the early addition of vasopressin modifies renal perfusion assessed ultrasoundally according to the CEUS method;
Measured: 7 days
addition of vasopressin modifies the fluid balance of patients
To assess the impact of early vasopressin association on the total amount of fluids administrated in the resuscitative phase of septic shock treatment, the fluid balance at 48 hours and 72 hours since ICU admission will be calculated for every subject, and compared between study and control group.
Measured: 48 and 72 hours
early combined treatment with vasopressin reduces the duration of the need for CRRT
verify whether early combined treatment with vasopressin reduces the duration of the need for CRRT (Continuous Renal Replacement Therapy) in patients who require such support during hospitalization in the ICU
Measured: 7 days
early association of vasopressin reduces the onset of supraventricular arrhythmias
verify whether the early association of vasopressin reduces the onset of supraventricular arrhythmias (atrial fibrillation, atrial flutter, paroxysmal supraventricular tachycardia) during treatment with vasopressor drugs
Measured: 7 days
intestinal and/or digital and/or limb ischemia;
The incidence of intestinal and/or digital and/or limb ischemia during the study period (7 days since enrollment) will be evaluated and compared between study and control group.
Measured: 7 days since enrollment
Length of stay in ICU
Length of stay in ICU (days) will be compared between study and control group
Measured: 28 and 90 days
Mortality
Mortality at 28 and 90 days will be evaluated for every subject and between study and control group
Measured: 28 and 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2024
- Study start15 May 2024
- Primary completion15 May 2026 (estimated)
- Study completion15 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be divided and randomized in a 1:1 ratio through a computer-generated scheme, when the dose of norepinephrine administered is ≥ 0.25 mcg/kg/min, into the following groups: * Group A: when the norepinephrine dosage is equal to or greater than 0.25 mcg/kg/min in the absence of adequate MAP (Mean arterial pressure \>65 mmhg), vasopressin infusion will be associated with the standard dosage of 0.3UI/min. * Group B (control): the infusion of vasopressin at a dosage of 0.3 IU/min will be associated if norepinephrine exceeds the dosage of 0.5 mcg/kg/min in the absence of adequate MAP.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 264 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Usl di Bologna
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06471231
- Sponsor's protocol ID
- 23171 - EVSS
- Acronym
- EVSS
- Status last verified
- May 2024
- First submitted
- 14 May 2024
- Last updated
- 24 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Renal Outcomes in the Early Use of Vasopressin in the Treatment of Septic Shock
- ClinicalTrials.gov ID
- NCT06471231
- Acronym / sponsor ID
- EVSS / 23171 - EVSS
- Conditions
- Septic Shock, Renal Function Replacement
- Keywords
- vasopressin, norepinephrine, renal function replacement, Septic Shock
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 264 participants (estimated)
- Lead sponsor
- Azienda Usl di BolognaOther government
- Study start
- 15 May 2024 (actual)
- Primary completion
- 15 May 2026 (estimated)
- Study completion
- 15 May 2026 (estimated)
- First posted
- 24 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the present study is to verify whether the earlier association of vasopressin and norepinephrine, in patients in septic shock, determines variations in terms of use of renal function replacement techniques in the first 7 days of hospitalization in Intensive Care, compared to patients in whom vasopressin is added only when norepinephrine reaches a higher dose.
Detailed description
The aim of the present study is to verify whether the earlier association of vasopressin and norepinephrine, in patients in septic shock, determines variations in terms of use of renal function replacement techniques in the first 7 days of hospitalization in Intensive Care, compared to patients in whom vasopressin is added only when norepinephrine reaches a higher dose. The study is aimed at patients admitted to the ICU with a diagnosis of septic shock on admission or in the first 24 hours of admission.
Patients will be divided and randomized in a 1:1 ratio through a computer-generated scheme, when the dose of norepinephrine administered is ≥ 0.25 mcg/kg/min, into the following groups:
- Group A: when the norepinephrine dosage is equal to or greater than 0.25 mcg/kg/min in the absence of adequate MAP (Mean arterial pressure >65 mmhg), vasopressin infusion will be associated with the standard dosage of 0.3UI/min.
- Group B (control): the infusion of vasopressin at a dosage of 0.3 IU/min will be associated if norepinephrine exceeds the dosage of 0.5 mcg/kg/min in the absence of adequate MAP.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Patients will be divided and randomized in a 1:1 ratio through a computer-generated scheme, when the dose of norepinephrine administered is ≥ 0.25 mcg/kg/min, into the following groups: * Group A: when the norepinephrine dosage is equal to or greater than 0.25 mcg/kg/min in the absence of adequate MAP (Mean arterial pressure >65 mmhg), vasopressin infusion will be associated with the standard dosage of 0.3UI/min. * Group B (control): the infusion of vasopressin at a dosage of 0.3 IU/min will be associated if norepinephrine exceeds the dosage of 0.5 mcg/kg/min in the absence of adequate MAP.
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: vasopressin infusion when the norepinephrine dosage is equal to or greater than 0.25 mcg/kg/minGroup A: when the norepinephrine dosage is equal to or greater than 0.25 mcg/kg/min in the absence of adequate MAP (Mean arterial pressure >65 mmhg), vasopressin infusion will be associated with the standard dosage of 0.3UI/min. |
| Group B | Active comparator | Drug: vasopressin infusion when the norepinephrine dosage is equal to or greater than 0.5 mcg/kg/minGroup B (control): the infusion of vasopressin at a dosage of 0.3 IU/min will be associated if norepinephrine exceeds the dosage of 0.5 mcg/kg/min in the absence of adequate MAP. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients suffering from septic shock hospitalized in an intensive setting
- patients over 18 years and under 80 years of age
- patients within 24 hours of clinical diagnosis, and requiring, in this time window, a norepinephrine dosage equal to or greater than 0.25 mcg/kg/min according to the patient's ideal weight (IBW)
- patients capable of expressing informed consent to treatment.
Key exclusion criteria (14 listed)
- patients in the absence of consent to participate in the study and to the processing of personal and particular data;
- patients under 18 years of age or over 80 years of age;
- patients who died within the first 24 hours of admission to the ICU;
- patients requiring a norepinephrine dosage lower than 0.25 mcg/kg/min in the first 24 hours of hospitalization in the ICU;
- patients with recent acute coronary syndrome (within the previous 7 days);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vasopressin infusion when the norepinephrine dosage is equal to or greater than 0.25 mcg/kg/minwhen the norepinephrine dosage is equal to or greater than 0.25 mcg/kg/min in the absence of adequate MAP (Mean arterial pressure >65 mmhg), vasopressin infusion will be associated with the standard dosage of 0.3UI/min. | Drug | Group A |
| vasopressin infusion when the norepinephrine dosage is equal to or greater than 0.5 mcg/kg/minthe infusion of vasopressin at a dosage of 0.3 IU/min will be associated if norepinephrine exceeds the dosage of 0.5 mcg/kg/min in the absence of adequate MAP | Drug | Group B |
Primary outcome
30% or more reduction in terms of the use of renal function replacement
Time frame: 7 days
The primary objective of the study is to verify whether the earlier association of vasopressin and norepinephrine determines a 30% or more reduction in terms of the use of renal function replacement techniques in the first 7 days of hospitalization in the Intensive Care Unit (ICU), compared to patients in whom the vasopressin is added only when norepinephrine reaches a higher dosage.
8 secondary outcomes
early association of vasopressin improves renal function
Time frame: 7 days
rly addition of vasopressin modifies renal perfusion
Time frame: 7 days
addition of vasopressin modifies the fluid balance of patients
Time frame: 48 and 72 hours
early combined treatment with vasopressin reduces the duration of the need for CRRT
Time frame: 7 days
early association of vasopressin reduces the onset of supraventricular arrhythmias
Time frame: 7 days
intestinal and/or digital and/or limb ischemia;
Time frame: 7 days since enrollment
Length of stay in ICU
Time frame: 28 and 90 days
Mortality
Time frame: 28 and 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing vasopressin infusion when the norepinephrine dosage is equal to or greater than 0.25 mcg/kg/min and vasopressin infusion when the norepinephrine dosage is equal to or greater than 0.5 mcg/kg/min in people with Septic Shock and Renal Function Replacement, run by Azienda Usl di Bologna at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lorenzo Giuntoli, Md (0516478868, lorenzo.giuntoli@ausl.bologna.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30% or more reduction in terms of the use of renal function replacement (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2024.