Vasoplegic ShockPhase 4ANGII_VNCT07671365
Angiotensin II for Post Cardiac Surgery Vasoplegia (ANGII_V)
A Phase 4 study testing Angiotensin II (Giapreza®) in people with Vasoplegic Shock and Cardiopulmonary Bypass, run by Methodist Healthcare System of San Antonio.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 94 years
- Conditions the study is for
- Vasoplegic Shock, Cardiopulmonary Bypass, Vasoplegia
- What is being tested?
- Angiotensin II (Giapreza®)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 329 participants
- Where
- No sites listed yet
- Study dates
- Jul 2026to Aug 2030
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 94 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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>
Show all 11Show fewer
- 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
About this study
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.
Read the detailed description
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.
- Conditions
- Vasoplegic Shock, Cardiopulmonary Bypass, Vasoplegia
- Being tested
- Angiotensin II (Giapreza®)
- Medical subject headings
- Vasoplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
in-hospital or post-hospital mortality within 1 year
Measured: 365 days
Secondary outcomes (3)
Mean Arterial Pressure
Changes in Mean Arterial Pressure
Measured: Hours 3, 6, 9, 12, 24 and 48,
Length of Stay
ICU
Measured: 1 year
Length of Stay
In Hospital, post ICU
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2026
- Study startJul 2026 (estimated)
- Primary completionJul 2029 (estimated)
- Study completionAug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Vasoplegic ShockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 329 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Methodist Healthcare System of San Antonio
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Craig Ainsworth, Methodist Healthcare System of San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07671365
- Sponsor's protocol ID
- ANGIIV01
- Acronym
- ANGII_V
- Status last verified
- Jun 2026
- First submitted
- 22 Jun 2026
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in any article, after deidentification (text,tables, figures, and appendices).
Publications
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.
PubMed 32019600Ten 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.
PubMed 35783549Khanna 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.
PubMed 28528561
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Angiotensin II for Post Cardiac Surgery Vasoplegia (ANGII_V)
- ClinicalTrials.gov ID
- NCT07671365
- Acronym / sponsor ID
- ANGII_V / ANGIIV01
- Conditions
- Vasoplegic Shock, Cardiopulmonary Bypass, Vasoplegia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 329 participants (estimated)
- Lead sponsor
- Methodist Healthcare System of San AntonioUniversity, hospital or other
- Study start
- Jul 2026 (estimated)
- Primary completion
- Jul 2029 (estimated)
- Study completion
- Aug 2030 (estimated)
- First posted
- 26 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ang II Administration using a modified Emory protocol | Experimental | Drug: Angiotensin II (Giapreza®)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. |
| 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. |
Who may qualify
- Ages
- 18 to 94 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
Key exclusion criteria (11 listed)
- An individual who meets any of the following criteria will be excluded from participation in this study:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | Ang II Administration using a modified Emory protocol |
Primary outcome
Mortality
Time frame: 365 days
in-hospital or post-hospital mortality within 1 year
3 secondary outcomes
Mean Arterial Pressure
Time frame: Hours 3, 6, 9, 12, 24 and 48,
Length of Stay
Time frame: 1 year
Length of Stay
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
- Background: PubMed 32019600Busse 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.
- Background: PubMed 35783549Ten 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.
- Background: PubMed 28528561Khanna 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.
- Giapreza drug information and package insertLink provided by the sponsor.
- Giapreza drug informationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in any article, after deidentification (text,tables, figures, and appendices).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Angiotensin II (Giapreza®) in people with Vasoplegic Shock and Cardiopulmonary Bypass, run by Methodist Healthcare System of San Antonio.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: 365 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07671365, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2026.