A Phase 4 interventional study of Angiotensin II (Giapreza®) in Vasoplegic Shock, Cardiopulmonary Bypass and Vasoplegia, sponsored by Methodist Healthcare System of San Antonio. Not yet recruiting. Open to participants aged 18 Years to 94 Years. Per ClinicalTrials.gov, last updated 2026-06-26.
Sponsored by Methodist Healthcare System of San Antonio · Phase 4, Interventional, and Treatment
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.
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.
48 studies on the registry are indexed under Vasoplegia; 19 are open to participants now.
This study's planned enrollment of 329 is above the median of 110 across 27 interventional studies indexed under Vasoplegia.
Browse Vasoplegia studies →This is the only study on the registry with Methodist Healthcare System of San Antonio as lead sponsor.
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An individual who meets any of the following criteria will be excluded from participation in this study:
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Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
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A drug or device being studied in a clinical trial.
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The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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®)
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.
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.
Mortality
in-hospital or post-hospital mortality within 1 year
Time frame: 365 days
Mean Arterial Pressure
Changes in Mean Arterial Pressure
Time frame: Hours 3, 6, 9, 12, 24 and 48,
Length of Stay
ICU
Time frame: 1 year
Length of Stay
In Hospital, post ICU
Time frame: 1 year
Re-admission
Re-admission to hospital for related event
Time frame: 1 year
No study locations are listed for this record.
Plan to share: Yes — Individual participant data that underlie the results reported in any article, after deidentification (text,tables, figures, and appendices).
Supporting information: 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.
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Angiotensin II