Registry of Patients in Shock Treated With Vasopressin

Last updated: July 11, 2024
Sponsor: Hospital Universitario 12 de Octubre
Overall Status: Active - Recruiting

Phase

N/A

Condition

Low Blood Pressure (Hypotension)

Treatment

Vasopressin

Clinical Study ID

NCT06422975
VASOPRES REGISTRY
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

  • Non-consent by patient/legal representatives

Study Design

Total Participants: 500
Treatment Group(s): 1
Primary Treatment: Vasopressin
Phase:
Study Start date:
July 09, 2024
Estimated Completion Date:
June 30, 2026

Study 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.

Connect with a study center

  • Hospital Universitario de A Coruña

    A Coruña,
    Spain

    Site Not Available

  • Hospital Universitario de Cruces

    Baracaldo,
    Spain

    Site Not Available

  • Hospital Universitario Valle de Hebrón

    Barcelona,
    Spain

    Site Not Available

  • Hospital de Sant Pau

    Barcelona,
    Spain

    Site Not Available

  • Hospital del Mar

    Barcelona,
    Spain

    Site Not Available

  • Hospital Universitario de Basurto

    Bilbao,
    Spain

    Site Not Available

  • Hospital de Donostia

    Donostia,
    Spain

    Site Not Available

  • Hospital General Universitario de Elche

    Elche,
    Spain

    Site Not Available

  • Hospital Universitario de Cabueñes

    Gijón,
    Spain

    Site Not Available

  • Complejo Asistencial Universitario de León

    León,
    Spain

    Site Not Available

  • Hospital Lucus Augustus

    Lugo,
    Spain

    Active - Recruiting

  • Hospital General Universitario Gregorio Marañón

    Madrid,
    Spain

    Site Not Available

  • Hospital Universitario 12 de Octubre

    Madrid,
    Spain

    Active - Recruiting

  • Hospital Universitario La Princesa

    Madrid,
    Spain

    Site Not Available

  • Hospital Universitario Ramón y Cajal

    Madrid,
    Spain

    Site Not Available

  • Hospital Universitario Puerta de Hierro Majadahonda

    Majadahonda,
    Spain

    Site Not Available

  • Complexo Hospitalario Universitario de Ourense

    Ourense,
    Spain

    Site Not Available

  • Hospital Universitario Central de Asturias

    Oviedo,
    Spain

    Site Not Available

  • Hospital Universitario Nuestra Señora de Candelaria

    Santa Cruz De Tenerife,
    Spain

    Site Not Available

  • Hospital Universitario Marqués de Valdecilla

    Santander,
    Spain

    Site Not Available

  • Hospital Clínico Universitario de Santiago

    Santiago De Compostela,
    Spain

    Site Not Available

  • Hospital Universitario Joan XXIII

    Tarragona,
    Spain

    Site Not Available

  • Hospital Clínico Universitario de Valencia

    Valencia,
    Spain

    Site Not Available

  • Hospital Universitari i Politècnic La Fe

    Valencia,
    Spain

    Site Not Available

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