Registry of Patients in Shock Treated With Vasopressin

Recruiting

• Conditions: Vasopressor Adverse Reaction; Vasopressin Causing Adverse Effects in Therapeutic Use; Shock; Vasopressin Deficiency

• Registration Number: NCT06422975
• Lead Sponsor: Hospital Universitario 12 de Octubre

Brief Summary

Arginine-vasopressin (AVP) is a non-catecholaminergic hormone produced in the hypothalamus and released into the circulation via the neurohypophysis. It has different actions depending on the receptors through which it acts: V1 (vasoconstriction, platelet aggregation, efferent arteriole constriction of the renal glomerulus, glycogenolysis); V2 (water reabsorption, release of von Willebrand factor and factor VIII); V3 (increased cortisol and insulin).

Septic shock is the most common cause of vasoplegic shock and its management includes control of the focus, early antibiotic therapy, volume resuscitation, vasopressor therapy, support of various organ dysfunctions, as well as monitoring and follow-up.

The Surviving Sepsis Campaign (a global initiative to improve sepsis management) recommends noradrenaline as the first line of vasopressor therapy and early addition of AVP as a second line rather than further up-titration of noradrenaline when signs of hypoperfusion persist, through its action primarily on V1.

The rationale for its use in septic shock would be:

* endogenous vasopressin deficiency present in septic shock;

* as a catecholamine-sparing strategy, reducing the side effects of catecholamines;

* its potential nephroprotective effect;

* its use should be early.

The uncertainties surrounding the use of AVP in septic shock and other types of shock are many, hence the need for this registry.

Detailed Description

The main objective is to characterise the routine clinical practice of vasopressin use in the context of shock in a multicentre observational study. By collecting clinical, analytical and echocardiographic data in a uniform manner, describing the time sequence of vasopressin and/or noradrenaline use; how long vasopressin is used; and which vasoconstrictor is more frequently withdrawn earlier: vasopressin or noradrenaline.

The secondary objectives are:

* to assess what motivated the decision to initiate AVP: type of shock, perfusion parameters, noradrenaline dose;

* to define the impact of initiating AVP on noradrenaline dose (whether the dose can be reduced or not), on cardiac function (whether echocardiographic data improve or worsen) and on perfusion data (whether laboratory and clinical data such as lactate, capillary refill time, mottling score or diuresis improve or worsen);

* estimate what is the dose range of AVP used and what is the maximum dose used in routine clinical practice;

* observe when AVP is stopped, how (abruptly or progressively);

* describe the incidence of side effects of AVP, whether it is related to the dose of AVP and the comorbidities of the patients;

* assess medium/long-term outcomes: 28- and 90-day mortality, ICU and hospital stay, days of vasopressor support, days of mechanical ventilation, days of renal replacement.

Study Timeline

• Status Verified: 2024-04
• Study First Submitted: 2024-04-29
• Study First Submitted QC: 2024-05-17
• Study First Posted: 2024-05-21
• Study Start: 2024-07-09
• Last Update Submitted: 2024-07-11
• Last Update Posted: 2024-07-15
• Primary Completion: 2026-06
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• Any patient over 18 years of age who is in shock and requires the administration of vasoconstrictors, to whom vasopressin is administered in the operating theatre and/or critical care unit, according to best clinical practice.

Exclusion Criteria

• Non-consent by patient/legal representatives

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Characterise the clinical practice of vasopressin use in the context of shock in a multicentre observational study.	90 days	Describing the time sequence of vasopressin and/or noradrenaline use (what is initiated first) during shock

Secondary Outcome Measures

Name	Time	Method
Observe when AVP is discontinued and how	Up to 7 days	Describe number of participants what AVP is discontinued first and how (abruptly or progressively)
Estimate the range of doses of AVP used	Up to 7 days	Estimate the range of doses of AVP used and the maximum dose used in routine clinical practice.
Incidence of new renal replacement therapy	From onset of shock until hospital discharge, an average of 2 weeks	New receipt of renal replacement therapy after onset of shock
Vasopressor-free days to day 28	28 days	Number of days between day 28 and the end of the last period of vasopressor therapy prior to day 28
Intensive care unit-free days to day 28	28 days	Number of days between day 28 and the end of the last period of intensive care unit admission prior to day 28.
Hospital-free days to day 28	28 days	Number of days between day 28 and the end of the last period of hospital admission prior to day 28
Assess what prompted the decision to initiate AVP	Up to 7 days	Assess what prompted the decision to initiate AVP: type of shock (vasoplegic, hypovolemic,...), perfusion parameters (as lactate) or noradrenaline dose (microgram/kg/minute)
Define the impact of starting AVP on noradrenaline dose	Up to 7 days	Define the impact of starting AVP on noradrenaline dose (microgram/kg/minute)
Define the impact of starting AVP on lactate level	Up to 7 days	Define the impact of starting AVP on lactate level (mmol/L)
Incidence of side effects	Up to 7 days	Describe the incidence of side effects, whether it is related to AVP dose and patients' comorbidities.
28-day all-cause mortality	28 days	Death on or before study day 28
90-day all-cause mortality	90 days	Death on or before study day 90

Trial Locations

Locations (24)

Hospital Universitario de A Coruña; 🇪🇸 A Coruña, Spain

Hospital Universitario de Cruces; 🇪🇸 Baracaldo, Spain

Hospital de Sant Pau; 🇪🇸 Barcelona, Spain

Hospital del Mar; 🇪🇸 Barcelona, Spain

Hospital Universitario Valle de Hebrón; 🇪🇸 Barcelona, Spain

Hospital Universitario de Basurto; 🇪🇸 Bilbao, Spain

Hospital de Donostia; 🇪🇸 Donostia, Spain

Hospital General Universitario de Elche; 🇪🇸 Elche, Spain

Hospital Universitario de Cabueñes; 🇪🇸 Gijón, Spain

Complejo Asistencial Universitario de León; 🇪🇸 León, Spain

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