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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 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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vasopressin infusion when the norepinephrine dosage is equal to or greater than 0.25 mcg/kg/min | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 7 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lorenzo Giuntoli, Md | Contact | 0516478868 | lorenzo.giuntoli@ausl.bologna.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda Unità Sanitaria Locale | Recruiting | Bologna | 40100 | Italy |
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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:
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An expert nephrology consultant has been included among the investigators to assess the need for CRRT according to KDIGO criteria, and he will be blinded to the subject allocation. In addition, the physicians who will perform ultrasound evaluation will be blinded to the subject allocation, in order to reduce the potential bias of overestimating the efficacy of the study treatment.
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| vasopressin infusion when the norepinephrine dosage is equal to or greater than 0.5 mcg/kg/min | Drug | 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 |
|
| rly addition of vasopressin modifies renal perfusion |
verify whether the early addition of vasopressin modifies renal perfusion assessed ultrasoundally according to the CEUS method; |
| 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. | 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 | 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 | 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. | 7 days since enrollment |
| Length of stay in ICU | Length of stay in ICU (days) will be compared between study and control group | 28 and 90 days |
| Mortality | Mortality at 28 and 90 days will be evaluated for every subject and between study and control group | 28 and 90 days |
| ID | Term |
|---|---|
| D012772 | Shock, Septic |
| D003919 | Diabetes Insipidus |
| ID | Term |
|---|---|
| D018805 | Sepsis |
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D010900 | Pituitary Diseases |
| D004700 | Endocrine System Diseases |
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