Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06422975
Status:
RECRUITING
Last Update Posted:
2024-07-15
First Post:
2024-04-29
Brief Title:
Registry of Patients in Shock Treated With Vasopressin
Sponsor:
Hospital Universitario 12 de Octubre
Organization:
Hospital Universitario 12 de Octubre
Study Overview
Official Title:
Prospective Multicentre Observational Study of Patients Treated With Vasopressin in Critical Care Units
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 andor 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 mediumlong-term outcomes 28- and 90-day mortality ICU and hospital stay days of vasopressor support days of mechanical ventilation days of renal replacement
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 mediumlong-term outcomes 28- and 90-day mortality ICU and hospital stay days of vasopressor support days of mechanical ventilation days of renal replacement
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None