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Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (8)

early association of vasopressin improves renal function
7 days
rly addition of vasopressin modifies renal perfusion
7 days
addition of vasopressin modifies the fluid balance of patients
48 and 72 hours
early combined treatment with vasopressin reduces the duration of the need for CRRT
7 days
early association of vasopressin reduces the onset of supraventricular arrhythmias
7 days
+3 more secondary outcomes

Study Arms (2)

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.

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.

Drug: vasopressin infusion when the norepinephrine dosage is equal to or greater than 0.5 mcg/kg/min

Interventions

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.

Group A

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

Registry intervention entries

These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.

Formulated product

Empressin 40 I.U./2 ml concentrato per soluzione per infusione

The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.

SOLUTION FOR INFUSION

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Formulated product

Empressin 40 I.U./2 ml concentrato per soluzione per infusione

The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.

SOLUTION FOR INFUSION

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Formulated product

SonoVue 8 microlitres/mL powder and solvent for dispersion for injection

The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.

DISPERSION FOR INJECTION

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Ingredients named in source formulations

The registry names these ingredients. The formulation’s exact chemical form has not been confirmed.

Empressin 40 I.U./2 ml concentrato per soluzione per infusione

Named ingredient: Argipressin

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Empressin 40 I.U./2 ml concentrato per soluzione per infusione

Named ingredient: Argipressin

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SonoVue 8 microlitres/mL powder and solvent for dispersion for injection

Named ingredient: Sulfur hexafluoride

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MeSH Terms

Conditions

Shock, SepticDiabetes Insipidus

Condition Hierarchy (Ancestors)

SepsisInfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShockKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Design

Study Type

interventional

Phase

phase 4

Allocation

RANDOMIZED

Masking

SINGLE

Who Masked

INVESTIGATOR

Masking Details

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.

Purpose

PREVENTION

Intervention Model

PARALLEL

Model Details: 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.

Sponsor Type

OTHER GOV

Responsible Party

SPONSOR

Renal Outcomes in the Early Use of Vasopressin in the Treatment of Septic Shock

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (8)

Study Arms (2)

Group A

Group B

Interventions

Registry intervention entries

Ingredients named in source formulations

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source records

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (8)

Study Arms (2)

Group A

Group B

Interventions

Registry intervention entries

Ingredients named in source formulations

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source records

Locations