## Protocol Section
### Identification Module
**NCT ID:** NCT06422975

**Brief Title:** Registry of Patients in Shock Treated With Vasopressin

**Official Title:** Prospective Multicentre Observational Study of Patients Treated With Vasopressin in Critical Care Units

#### Organization Study ID Info
**ID:** VASOPRES REGISTRY
#### Organization
**Class:** OTHER
**Full Name:** Hospital Universitario 12 de Octubre
### Status Module
#### Completion Date
**Date:** 2026-06

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-23

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2026-06

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06

**Type:** ESTIMATED

**Status Verified Date:** 2024-04

#### Study First Post Date
**Date:** 2024-05-21
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-29
**Study First Submit QC Date:** 2024-05-17
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Hospital Universitario 12 de Octubre

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** True

**Is US Export:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Vasopressin Causing Adverse Effects in Therapeutic Use

- Shock

- Vasopressor Adverse Reaction

- Vasopressin Deficiency

**Keywords:**

- Vasopressin

- Shock

### Design Module

#### Design Info

**Observational Model:** OTHER

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 500

**Type:** ESTIMATED

**Patient Registry:** True

**Study Type:** OBSERVATIONAL

**Target Duration:** 90 Days

### Arms Interventions Module

### Interventions

#### Intervention 1

**Description:** Patients treated with vasopressin

**Name:** Vasopressin

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Describing the time sequence of vasopressin and/or noradrenaline use (what is initiated first) during shock

**Measure:** Characterise the clinical practice of vasopressin use in the context of shock in a multicentre observational study.

**Time Frame:** 90 days

#### Secondary Outcomes

**Description:** Assess what prompted the decision to initiate AVP: type of shock (vasoplegic, hypovolemic,...), perfusion parameters (as lactate) or noradrenaline dose (microgram/kg/minute)

**Measure:** Assess what prompted the decision to initiate AVP

**Time Frame:** Up to 7 days

**Description:** Define the impact of starting AVP on noradrenaline dose (microgram/kg/minute)

**Measure:** Define the impact of starting AVP on noradrenaline dose

**Time Frame:** Up to 7 days

**Description:** Define the impact of starting AVP on lactate level (mmol/L)

**Measure:** Define the impact of starting AVP on lactate level

**Time Frame:** Up to 7 days

**Description:** Describe number of participants what AVP is discontinued first and how (abruptly or progressively)

**Measure:** Observe when AVP is discontinued and how

**Time Frame:** Up to 7 days

**Description:** Estimate the range of doses of AVP used and the maximum dose used in routine clinical practice.

**Measure:** Estimate the range of doses of AVP used

**Time Frame:** Up to 7 days

**Description:** Describe the incidence of side effects, whether it is related to AVP dose and patients' comorbidities.

**Measure:** Incidence of side effects

**Time Frame:** Up to 7 days

**Description:** Death on or before study day 28

**Measure:** 28-day all-cause mortality

**Time Frame:** 28 days

**Description:** Death on or before study day 90

**Measure:** 90-day all-cause mortality

**Time Frame:** 90 days

**Description:** New receipt of renal replacement therapy after onset of shock

**Measure:** Incidence of new renal replacement therapy

**Time Frame:** From onset of shock until hospital discharge, an average of 2 weeks

**Description:** Number of days between day 28 and the end of the last period of vasopressor therapy prior to day 28

**Measure:** Vasopressor-free days to day 28

**Time Frame:** 28 days

**Description:** Number of days between day 28 and the end of the last period of intensive care unit admission prior to day 28.

**Measure:** Intensive care unit-free days to day 28

**Time Frame:** 28 days

**Description:** Number of days between day 28 and the end of the last period of hospital admission prior to day 28

**Measure:** Hospital-free days to day 28

**Time Frame:** 28 days

### Eligibility Module

**Eligibility Criteria:** 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

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Patients in shock receiving vasopressin

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** raquelgarciaalvarez@gmail.com

**Name:** Raquel García Álvarez, MD

**Phone:** +34913908243

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** A Coruña

**Contacts:**

***Contact 1:***

- **Name:** Pablo Rama Maceiras

- **Role:** CONTACT

**Country:** Spain

**Facility:** Hospital Universitario de A Coruña

**Location 2:**

**City:** Baracaldo

**Contacts:**

***Contact 1:***

- **Name:** Gontzal Tamayo

- **Role:** CONTACT

**Country:** Spain

**Facility:** Hospital Universitario de Cruces

**Location 3:**

**City:** Barcelona

**Contacts:**

***Contact 1:***

- **Name:** Marta Giné Servén

- **Role:** CONTACT

**Country:** Spain

**Facility:** Hospital de Sant Pau

**Location 4:**

**City:** Barcelona

**Contacts:**

***Contact 1:***

- **Name:** Ramón Adalia

- **Role:** CONTACT

**Country:** Spain

**Facility:** Hospital del Mar

**Location 5:**

**City:** Barcelona

**Country:** Spain

**Facility:** Hospital Universitario Valle de Hebrón

**Location 6:**

**City:** Bilbao

**Contacts:**

***Contact 1:***

- **Name:** Felipe Ortega Palacios

- **Role:** CONTACT

**Country:** Spain

**Facility:** Hospital Universitario de Basurto

**Location 7:**

**City:** Donostia

**Contacts:**

***Contact 1:***

- **Name:** Cristina García Fernández

- **Role:** CONTACT

**Country:** Spain

**Facility:** Hospital de Donostia

**Location 8:**

**City:** Elche

**Contacts:**

***Contact 1:***

- **Name:** Ana Pérez Carbonell

- **Role:** CONTACT

**Country:** Spain

**Facility:** Hospital General Universitario de Elche

**Location 9:**

**City:** Gijón

**Country:** Spain

**Facility:** Hospital Universitario de Cabueñes

**Location 10:**

**City:** León

**Contacts:**

***Contact 1:***

- **Name:** Rafael González de Castro

- **Role:** CONTACT

**Country:** Spain

**Facility:** Complejo Asistencial Universitario de León

**Location 11:**

**City:** Lugo

**Contacts:**

***Contact 1:***

- **Name:** Lorena Mouritz

- **Role:** CONTACT

**Country:** Spain

**Facility:** Hospital Lucus Augustus

**Location 12:**

**City:** Madrid

**Contacts:**

***Contact 1:***

- **Name:** Carlos Alberto Calvo García

- **Role:** CONTACT

**Country:** Spain

**Facility:** Hospital General Universitario Gregorio Marañón

**Location 13:**

**City:** Madrid

**Contacts:**

***Contact 1:***

- **Email:** raquelgarciaalvarez@gmail.com

- **Name:** Raquel García Álvarez

- **Role:** CONTACT

**Country:** Spain

**Facility:** Hospital Universitario 12 de Octubre

**Location 14:**

**City:** Madrid

**Contacts:**

***Contact 1:***

- **Name:** Fernando Ramasco Rueda

- **Role:** CONTACT

***Contact 2:***

- **Name:** Jesús Nieves Alonso

- **Role:** CONTACT

**Country:** Spain

**Facility:** Hospital Universitario La Princesa

**Location 15:**

**City:** Madrid

**Country:** Spain

**Facility:** Hospital Universitario Ramón y Cajal

**Location 16:**

**City:** Majadahonda

**Contacts:**

***Contact 1:***

- **Name:** Reyes Iranzo

- **Role:** CONTACT

**Country:** Spain

**Facility:** Hospital Universitario Puerta de Hierro Majadahonda

**Location 17:**

**City:** Ourense

**Contacts:**

***Contact 1:***

- **Name:** Concepción Alonso

- **Role:** CONTACT

**Country:** Spain

**Facility:** Complexo Hospitalario Universitario de Ourense

**Location 18:**

**City:** Oviedo

**Contacts:**

***Contact 1:***

- **Name:** Beatriz Mancha Getino

- **Role:** CONTACT

**Country:** Spain

**Facility:** Hospital Universitario Central de Asturias

**Location 19:**

**City:** Santa Cruz De Tenerife

**Contacts:**

***Contact 1:***

- **Name:** David Domínguez

- **Role:** CONTACT

**Country:** Spain

**Facility:** Hospital Universitario Nuestra Señora de Candelaria

**Location 20:**

**City:** Santander

**Contacts:**

***Contact 1:***

- **Name:** Adriana Ixquic Reyes Echeverria

- **Role:** CONTACT

**Country:** Spain

**Facility:** Hospital Universitario Marqués de Valdecilla

**Location 21:**

**City:** Santiago De Compostela

**Contacts:**

***Contact 1:***

- **Name:** Manuel Taboada

- **Role:** CONTACT

**Country:** Spain

**Facility:** Hospital Clínico Universitario de Santiago

**Location 22:**

**City:** Tarragona

**Contacts:**

***Contact 1:***

- **Name:** Diego Prendes Fernández

- **Role:** CONTACT

**Country:** Spain

**Facility:** Hospital Universitario Joan XXIII

**Location 23:**

**City:** Valencia

**Contacts:**

***Contact 1:***

- **Name:** Gerardo Aguilar

- **Role:** CONTACT

**Country:** Spain

**Facility:** Hospital Clínico Universitario de Valencia

**Location 24:**

**City:** Valencia

**Contacts:**

***Contact 1:***

- **Name:** Miguel Ángel Rodenas

- **Role:** CONTACT

**Country:** Spain

**Facility:** Hospital Universitari i Politècnic La Fe

#### Overall Officials

**Official 1:**

**Affiliation:** Hospital Universitario 12 de Octubre

**Name:** Raquel García Álvarez

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** UNDECIDED

### References Module

#### References

**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.

**PMID:** 38003863

**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.

**PMID:** 16931995

**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.

**PMID:** 16931974

**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.

**PMID:** 38392609

**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, Centofanti J, Coz Yataco A, De Waele J, Dellinger RP, Doi K, Du B, Estenssoro E, Ferrer R, Gomersall C, Hodgson C, Moller MH, Iwashyna T, Jacob S, Kleinpell R, Klompas M, Koh Y, Kumar A, Kwizera A, Lobo S, Masur H, McGloughlin S, Mehta S, Mehta Y, Mer M, Nunnally M, Oczkowski S, Osborn T, Papathanassoglou E, Perner A, Puskarich M, Roberts J, Schweickert W, Seckel M, Sevransky J, Sprung CL, Welte T, Zimmerman J, Levy M. Surviving sepsis campaign: international guidelines for management of sepsis and septic shock 2021. Intensive Care Med. 2021 Nov;47(11):1181-1247. doi: 10.1007/s00134-021-06506-y. Epub 2021 Oct 2. No abstract available.

**PMID:** 34599691

**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.

**PMID:** 12794416

**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.

**PMID:** 11555538

**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.

**PMID:** 26125087

**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 Feb 28;358(9):877-87. doi: 10.1056/NEJMoa067373.

**PMID:** 18305265

**Citation:** 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.

**PMID:** 31970567

**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: 10.1007/s00134-009-1687-x. Epub 2009 Oct 20.

**PMID:** 19841897

**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.

**PMID:** 37510705

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000010335

- Term: Pathologic Processes

- ID: D000003919

- Term: Diabetes Insipidus

- ID: D000007674

- Term: Kidney Diseases

- ID: D000014570

- Term: Urologic Diseases

- ID: D000052776

- Term: Female Urogenital Diseases

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000052801

- Term: Male Urogenital Diseases

- ID: D000010900

- Term: Pituitary Diseases

- ID: D000004700

- Term: Endocrine System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: BC19

- Name: Gland and Hormone Related Diseases

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M15577

- Name: Shock

- Relevance: HIGH

- As Found: Shock

- ID: M22545

- Name: Diabetes Insipidus, Neurogenic

- Relevance: HIGH

- As Found: Vasopressin Deficiency

- ID: M7115

- Name: Diabetes Mellitus

- Relevance: LOW

- As Found: Unknown

- ID: M7114

- Name: Diabetes Insipidus

- Relevance: LOW

- As Found: Unknown

- ID: M10698

- Name: Kidney Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17319

- Name: Urologic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14127

- Name: Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M27095

- Name: Male Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M13791

- Name: Pituitary Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7862

- Name: Endocrine System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T1030

- Name: Central Diabetes Insipidus

- Relevance: HIGH

- As Found: Vasopressin Deficiency

### Condition Browse Module - Meshes

- ID: D000020790

- Term: Diabetes Insipidus, Neurogenic

- ID: D000012769

- Term: Shock

### Intervention Browse Module - Ancestors

- ID: D000006490

- Term: Hemostatics

- ID: D000003029

- Term: Coagulants

- ID: D000014662

- Term: Vasoconstrictor Agents

- ID: D000050034

- Term: Antidiuretic Agents

- ID: D000045283

- Term: Natriuretic Agents

- ID: D000045505

- Term: Physiological Effects of Drugs

### Intervention Browse Module - Browse Branches

- Abbrev: NaAg

- Name: Natriuretic Agents

- Abbrev: VaCoAg

- Name: Vasoconstrictor Agents

- Abbrev: Coag

- Name: Coagulants

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: AA

- Name: Amino Acids

### Intervention Browse Module - Browse Leaves

- ID: M17414

- Name: Vasopressins

- Relevance: HIGH

- As Found: Contained

- ID: M4437

- Name: Arginine Vasopressin

- Relevance: HIGH

- As Found: Contained

- ID: M9576

- Name: Hemostatics

- Relevance: LOW

- As Found: Unknown

- ID: M6259

- Name: Coagulants

- Relevance: LOW

- As Found: Unknown

- ID: M17409

- Name: Vasoconstrictor Agents

- Relevance: LOW

- As Found: Unknown

- ID: T1

- Name: Arginine

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000014667

- Term: Vasopressins

- ID: D000001127

- Term: Arginine Vasopressin

### Misc Info Module

- Version Holder: 2024-05-31
