Registry of Patients in Shock Treated With Vasopressin

Shock Clinical Trial

Official title:

Prospective Multicentre Observational Study of Patients Treated With Vasopressin in Critical Care Units

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06422975
• Other study ID #: VASOPRES REGISTRY
• Status: Not yet recruiting
• Start date: June 2024
• Est. completion date: June 2026

Study information

• Verified date: April 2024
• Source: Hospital Universitario 12 de Octubre
• Contact: Raquel García Álvarez, MD
• Phone: +34913908243
• Email: raquelgarciaalvarez[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: June 2026
• Est. primary completion date: June 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Shock

Intervention

Drug:
• Vasopressin
Patients treated with vasopressin

Locations

Country	Name	City	State
Spain	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	Hospital Lucus Augustus	Lugo
Spain	Hospital General Universitario Gregorio Marañón	Madrid
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	Hospital Universitario La Princesa	Madrid
Spain	Hospital Universitario Ramón y Cajal	Madrid
Spain	Hospital Universitario Puerta de Hierro Majadahonda	Majadahonda
Spain	Complexo Hospitalario Universitario de Ourense	Ourense
Spain	Hospital Universitario Central de Asturias	Oviedo
Spain	Hospital Universitario Nuestra Señora de Candelaria	Santa Cruz De Tenerife
Spain	Hospital Universitario Marqués de Valdecilla	Santander
Spain	Hospital Clínico Universitario de Santiago	Santiago De Compostela
Spain	Hospital Universitario Joan XXIII	Tarragona
Spain	Hospital Clínico Universitario de Valencia	Valencia
Spain	Hospital Universitari i Politècnic La Fe	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitario 12 de Octubre

Country where clinical trial is conducted

Spain, 

References & Publications (12)

Demiselle J, Fage N, Radermacher P, Asfar P. Vasopressin and its analogues in shock states: a review. Ann Intensive Care. 2020 Jan 22;10(1):9. doi: 10.1186/s13613-020-0628-2. — View Citation

Dunser MW, Lindner KH, Wenzel V. A century of arginine vasopressin research leading to new therapeutic strategies. Anesthesiology. 2006 Sep;105(3):444-5. doi: 10.1097/00000542-200609000-00004. No abstract available. — View Citation

Evans L, Rhodes A, Alhazzani W, Antonelli M, Coopersmith CM, French C, Machado FR, Mcintyre L, Ostermann M, Prescott HC, Schorr C, Simpson S, Wiersinga WJ, Alshamsi F, Angus DC, Arabi Y, Azevedo L, Beale R, Beilman G, Belley-Cote E, Burry L, Cecconi M, Ce — View Citation

Garcia-Alvarez R, Arboleda-Salazar R. Vasopressin in Sepsis and Other Shock States: State of the Art. J Pers Med. 2023 Oct 29;13(11):1548. doi: 10.3390/jpm13111548. — View Citation

Gordon AC, Russell JA, Walley KR, Singer J, Ayers D, Storms MM, Holmes CL, Hebert PC, Cooper DJ, Mehta S, Granton JT, Cook DJ, Presneill JJ. The effects of vasopressin on acute kidney injury in septic shock. Intensive Care Med. 2010 Jan;36(1):83-91. doi: — View Citation

Hamzaoui O, Goury A, Teboul JL. The Eight Unanswered and Answered Questions about the Use of Vasopressors in Septic Shock. J Clin Med. 2023 Jul 10;12(14):4589. doi: 10.3390/jcm12144589. — View Citation

Holmes CL, Patel BM, Russell JA, Walley KR. Physiology of vasopressin relevant to management of septic shock. Chest. 2001 Sep;120(3):989-1002. doi: 10.1378/chest.120.3.989. — View Citation

Martin C, Medam S, Antonini F, Alingrin J, Haddam M, Hammad E, Meyssignac B, Vigne C, Zieleskiewicz L, Leone M. NOREPINEPHRINE: NOT TOO MUCH, TOO LONG. Shock. 2015 Oct;44(4):305-9. doi: 10.1097/SHK.0000000000000426. — View Citation

Ramasco F, Nieves-Alonso J, Garcia-Villabona E, Vallejo C, Kattan E, Mendez R. Challenges in Septic Shock: From New Hemodynamics to Blood Purification Therapies. J Pers Med. 2024 Feb 3;14(2):176. doi: 10.3390/jpm14020176. — View Citation

Russell JA, Walley KR, Singer J, Gordon AC, Hebert PC, Cooper DJ, Holmes CL, Mehta S, Granton JT, Storms MM, Cook DJ, Presneill JJ, Ayers D; VASST Investigators. Vasopressin versus norepinephrine infusion in patients with septic shock. N Engl J Med. 2008 — View Citation

Sharshar T, Blanchard A, Paillard M, Raphael JC, Gajdos P, Annane D. Circulating vasopressin levels in septic shock. Crit Care Med. 2003 Jun;31(6):1752-8. doi: 10.1097/01.CCM.0000063046.82359.4A. — View Citation

Treschan TA, Peters J. The vasopressin system: physiology and clinical strategies. Anesthesiology. 2006 Sep;105(3):599-612; quiz 639-40. doi: 10.1097/00000542-200609000-00026. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

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