Registry of Patients in Shock Treated With Vasopressin
- Conditions
- Vasopressor Adverse ReactionVasopressin Causing Adverse Effects in Therapeutic UseShockVasopressin 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of vasopressin and/or noradrenaline use; how long vasopressin is used; and which vasoconstrictor is more frequently withdrawn earlier: vasopressin or noradrenaline.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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 500
- 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.
- 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 Basurto
🇪🇸Bilbao, Spain
Hospital Universitario de Cruces
🇪🇸Baracaldo, Spain
Hospital Lucus Augustus
🇪🇸Lugo, Spain
Hospital Universitario de A Coruña
🇪🇸A Coruña, Spain
Complexo Hospitalario Universitario de Ourense
🇪🇸Ourense, Spain
Hospital Universitario Ramón y Cajal
🇪🇸Madrid, Spain
Hospital Universitario Marqués de Valdecilla
🇪🇸Santander, Spain
Hospital Universitari i Politècnic La Fe
🇪🇸Valencia, Spain
Hospital Clínico Universitario de Valencia
🇪🇸Valencia, Spain
Hospital General Universitario Gregorio Marañón
🇪🇸Madrid, Spain
Hospital Universitario Joan XXIII
🇪🇸Tarragona, Spain
Hospital Universitario Puerta de Hierro Majadahonda
🇪🇸Majadahonda, Spain
Hospital del Mar
🇪🇸Barcelona, Spain
Hospital de Sant Pau
🇪🇸Barcelona, Spain
Hospital de Donostia
🇪🇸Donostia, Spain
Hospital Universitario Valle de Hebrón
🇪🇸Barcelona, Spain
Complejo Asistencial Universitario de León
🇪🇸León, Spain
Hospital General Universitario de Elche
🇪🇸Elche, Spain
Hospital Universitario de Cabueñes
🇪🇸Gijón, Spain
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain
Hospital Universitario La Princesa
🇪🇸Madrid, Spain
Hospital Universitario Central de Asturias
🇪🇸Oviedo, Spain
Hospital Universitario Nuestra Señora de Candelaria
🇪🇸Santa Cruz De Tenerife, Spain
Hospital Clínico Universitario de Santiago
🇪🇸Santiago De Compostela, Spain