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Angiotensin II for Post Cardiac Surgery Vasoplegia (ANGII_V) (ANGII_V)

22. juni 2026 opdateret af: Craig Ainsworth, Methodist Healthcare System of San Antonio
The goal of this study is to conduct a prospective trial implementing a modified version of the Emory Protocol for administering ANG II to patients with post cardiac bypass vasoplegia. The main questions we aim to answer are: 1.) does administration of improve mortality, 2.) does the administration of Ang II using the modified protocol shorten the time needed to reach optimal MAP, 3.) does the administration of Ang II using the modified protocol shorten length of stay in the ICU and hospital? Researchers will compare outcomes from the interventional group to historical controls who did not receive Ang II using the modified protocol.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Giapreza is a synthetic human Ang II treatment which acts as a RAAS pathway regulator to rais MAP in adults. This will be a single center study comparing patients treated with a modified Emory protocol to historical controls who have not received Ang II. We will observe the effects of using a modified version of the Emory protocol, which includes lowering the dosages needed for norepinephrine and vasopressin. Additionally, clinicians will administer Ang II prior to starting methylene blue, a drug that poses more risk to patients than Ang II. Using this modified version of this protocol, patients who have post cardiopulmonary bypass vasoplegia who are already on vasopressin 0.04 units/min, norepinephrine 0.1 mcg/kg/min will have Ang II initiated at 10 to 20 ng/kg/min and titrated by 10 ng/kg/min every 5 minutes to a maximum dose of 80 ng/kg/min. If patients do not achieve their MAP goal of 65mmHg or greater within 3 hours, then they will have ANG II discontinued and will receive a dose of methylene blue at 2 mg/kg. If the patients do not achieve their MAP goal with methylene blue then they will receive a cyanokit.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

329

Fase

  • Fase 4

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • In order to be eligible to participate in this study, an individual must meet all of the following criteria:

    1. Provision of signed and dated informed consent form
    2. Stated willingness to comply with all study procedures and availability for the duration of the study
    3. Male or female, aged 18 or over
    4. Exhibiting vasoplegia or vasoplegic shock following surgeries involving cardiopulmonary bypass
    5. MAP below results below 65mmHg

Exclusion Criteria:

  • An individual who meets any of the following criteria will be excluded from participation in this study:

    1. Current use of angiotensin converting enzyme (ACE) inhibitors or angiotensin II receptor blockers (ARBs)
    2. Presence of treatment with high-dose glucocorticoids
    3. Pregnancy or lactation
    4. Known allergic reactions to components of the Giapreza, <specify components/allergens>
    5. Febrile illness within <specify time frame>
    6. Treatment with another investigational drug or other intervention within <specify time frame>
    7. Current smoker or tobacco use within <specify timeframe>
    8. Currently receiving VA ECMO for cardiogenic shock
    9. Experiencing uncontrolled hemorrhage
    10. Presenting with burns over 20% or more of body, acute coronary syndrome, bronchial spasms, liver failure, mesenteric ischemia, abdominal aortic aneurysm, or an absolute neutrophil count less than 1000 cubic millimeters

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Ang II Administration using a modified Emory protocol
Using this modified version of this protocol, patients who have post cardiopulmonary bypass vasoplegia who are already on vasopressin 0.04 units/min, norepinephrine 0.1 mcg/kg/min will have Ang II initiated at 10 to 20 ng/kg/min and titrated by 10 ng/kg/min every 5 minutes to a maximum dose of 80 ng/kg/min. Case report forms (CRF) tracking MAP and dosage of drugs will be completed for each patient for up to 48 hours.
Medicin: Angiotensin II (Giapreza®)
Patients who have post cardiopulmonary bypass vasoplegia who are already on vasopressin 0.04 units/min, norepinephrine 0.1 mcg/kg/min will have Ang II initiated at 10 to 20 ng/kg/min and titrated by 10 ng/kg/min every 5 minutes to a maximum dose of 80 ng/kg/min.
Ingen indgriben: Evaluating Effectiveness of modified Emory Protocol on outcomes from vasoplegia after bypass
Historical controls will be extracted from EMR and selected based on 1:1 matching with patients in experimental arm. Matching will be based on a number of factors. Descriptive and comparative analyses will be conducted.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Mortality
Tidsramme: 365 days
in-hospital or post-hospital mortality within 1 year
365 days

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Mean Arterial Pressure
Tidsramme: Hours 3, 6, 9, 12, 24 and 48,
Changes in Mean Arterial Pressure
Hours 3, 6, 9, 12, 24 and 48,
Length of Stay
Tidsramme: 1 year
ICU
1 year
Length of Stay
Tidsramme: 1 year
In Hospital, post ICU
1 year

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Re-admission
Tidsramme: 1 year
Re-admission to hospital for related event
1 year

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Methodist Healthcare System of San Antonio

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juli 2026

Primær færdiggørelse (Anslået)

1. juli 2029

Studieafslutning (Anslået)

1. august 2030

Datoer for studieregistrering

Først indsendt

22. juni 2026

Først indsendt, der opfyldte QC-kriterier

22. juni 2026

Først opslået (Faktiske)

26. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

26. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

22. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • ANGIIV01

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Individual participant data that underlie the results reported in any article, after deidentification (text,tables, figures, and appendices).

IPD-delingstidsramme

Beginning 9 months after and ending 36 months following any article publication.

IPD-delingsadgangskriterier

Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Kardiopulmonal bypass

Kliniske forsøg med Angiotensin II (Giapreza®)

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