Angiotensin II for Post Cardiac Surgery Vasoplegia (ANGII_V)

NCT07671365 | Not Yet Recruiting Phase 4 FDA Drug

• 1 other identifier: ANGIIV01
• Study Type: interventional
• Target: 329
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Vasoplegic Shock; Cardiopulmonary Bypass; Vasoplegia

Outcome Measures

Primary Outcomes (1)

• Mortality

  in-hospital or post-hospital mortality within 1 year

  365 days

Secondary Outcomes (3)

• Mean Arterial Pressure

  Hours 3, 6, 9, 12, 24 and 48,

• Length of Stay

  1 year

• Length of Stay

  1 year

Other Outcomes (1)

• Re-admission

  1 year

Study Arms (2)

Ang II Administration using a modified Emory protocol

EXPERIMENTAL

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.

Drug: Angiotensin II (Giapreza®)

Evaluating Effectiveness of modified Emory Protocol on outcomes from vasoplegia after bypass

NO INTERVENTION

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.

Interventions

Angiotensin II (Giapreza®) DRUG

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.

Ang II Administration using a modified Emory protocol

Eligibility Criteria

• Age: 18 Years - 94 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• In order to be eligible to participate in this study, an individual must meet all of the following criteria:
• Provision of signed and dated informed consent form
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Male or female, aged 18 or over
• Exhibiting vasoplegia or vasoplegic shock following surgeries involving cardiopulmonary bypass
• MAP below results below 65mmHg

You may not qualify if:

• An individual who meets any of the following criteria will be excluded from participation in this study:
• Current use of angiotensin converting enzyme (ACE) inhibitors or angiotensin II receptor blockers (ARBs)
• Presence of treatment with high-dose glucocorticoids
• Pregnancy or lactation
• Known allergic reactions to components of the Giapreza, \<specify components/allergens\>
• Febrile illness within \<specify time frame\>
• Treatment with another investigational drug or other intervention within \<specify time frame\>
• Current smoker or tobacco use within \<specify timeframe\>
• Currently receiving VA ECMO for cardiogenic shock
• Experiencing uncontrolled hemorrhage
• 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

Sponsors & Collaborators

• Methodist Healthcare System of San Antonio: lead

Related Publications (3)

• Busse LW, Barker N, Petersen C. Vasoplegic syndrome following cardiothoracic surgery-review of pathophysiology and update of treatment options. Crit Care. 2020 Feb 4;24(1):36. doi: 10.1186/s13054-020-2743-8.

  PMID: 32019600 BACKGROUND

• Ten Lohuis CC, Burke SC, Jannuzzo CJ, Barker NA, Chen EP, Busse LW. Protocol Compliance Guiding Angiotensin II Use in Post Cardiovascular Surgery Vasoplegia. Crit Care Explor. 2022 May 13;4(5):e0687. doi: 10.1097/CCE.0000000000000687. eCollection 2022 May.

  PMID: 35783549 BACKGROUND

• Khanna A, English SW, Wang XS, Ham K, Tumlin J, Szerlip H, Busse LW, Altaweel L, Albertson TE, Mackey C, McCurdy MT, Boldt DW, Chock S, Young PJ, Krell K, Wunderink RG, Ostermann M, Murugan R, Gong MN, Panwar R, Hastbacka J, Favory R, Venkatesh B, Thompson BT, Bellomo R, Jensen J, Kroll S, Chawla LS, Tidmarsh GF, Deane AM; ATHOS-3 Investigators. Angiotensin II for the Treatment of Vasodilatory Shock. N Engl J Med. 2017 Aug 3;377(5):419-430. doi: 10.1056/NEJMoa1704154. Epub 2017 May 21.

  PMID: 28528561 BACKGROUND

Related Links

• Giapreza drug information and package insert
• Giapreza drug information

MeSH Terms

Conditions

Vasoplegia

Interventions

Angiotensin II; Giapreza

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Angiotensins; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Autacoids; Inflammation Mediators; Biological Factors

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician, Critical Care Medicine

Study Record Dates

• First Submitted: June 22, 2026
• First Posted: June 26, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): July 1, 2029
• Study Completion (Estimated): August 1, 2030
• Last Updated: June 26, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 9 months after and ending 36 months following any article publication.
• Access Criteria: Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose.