A Phase 4 interventional study of Angiotensin II and Placebo in Distributive Shock, sponsored by Northwestern University. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-13.
Sponsored by Northwestern University · Phase 4, Interventional, and Prevention
This is a single-center, randomized, double-blind, placebo-controlled pilot study. A total of 40 patients who develop distributive shock, intra-operatively or post-operatively within 48 hours of heart transplant or left ventricular assist device placement will be enrolled. Participants will be randomized to Angiotensin II (Giapreza) vs. placebo plus standard of care, as a first line agent for vasoplegia. Two groups of patients will be enrolled:
Patients undergoing implantation of a durable left ventricular assist devices (LVAD) or a heart transplantation are at increased risk for cardiac vasoplegia. Vasoplegia, during or following cardiac surgery, is a life-threatening condition that is characterized by poor organ perfusion and may progress to multi-organ failure. The prognosis is especially poor for patients with refractory hypotension, despite high doses of vasopressors. Existing data point to total catecholamine dose, cumulative time spent with hypotension, volume overload, need for blood transfusion as contributing factors. Catecholamine vasopressors and vasopressin, which are often used as first line vasopressor therapy, are also independent risk factors for end organ dysfunction. Data comparing mortality with the use of different classes of vasopressors, in various types of shock, have been equivocal to date. In addition, data comparing the use of different classes of vasopressors for vasoplegia during or after heart transplantation and LVAD implantation are lacking. In patients with distributive shock in the intensive care unit, angiotensin II has been shown to reduce total catecholamine dose over 24 hours and the cumulative time spent with hypotension. This study will evaluate, as the primary endpoint, whether first line use of angiotensin II affects total catecholamine vasopressor dose in the first 24 hours after vasoplegia is first. Secondary endpoints include cumulative time spent with mean arterial pressure \< 70 mmHg within the first 24 hours after distributive shock is first diagnosed, need for vasoplegia rescue therapies (methylene blue, vitamin B12, Vitamin C, steroids), incidence of acute kidney injury and stroke, time to extubation, incidence of new tachyarrhythmias, need for blood transfusion and fluid overload within the first 24 hours, ICU and hospital length of stay, 30-day mortality and allograft rejection (for heart transplant recipients).
48 studies on the registry are indexed under Vasoplegia; 19 are open to participants now.
This study's enrollment of 2 is below the median of 110 across 27 interventional studies indexed under Vasoplegia.
Browse Vasoplegia studies →Northwestern University is the lead sponsor of 1,423 studies on the registry; 198 are open to participants now.
Of its 105 completed or terminated interventional studies of FDA-regulated products, 78 (74%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Angiotensin II administered as an intravenous (IV) infusion will be increased every 5 minutes by 5-10ng/kg/min increments up to 80ng/kg/min
Drug: Angiotensin II
Intravenous (IV) infusion (saline)
Drug: Placebo
Angiotensin II started at 5 ng/kg/min and titrated in 5-10 ng/kg/min increments every 5 minutes up to 80ng/kg/min to achieve target arterial pressure (MAP)
Also known as: Giapreza
Placebo
Also known as: Saline solution
Total Catecholamine Dose
Total catecholamine dose for first 24 hours after distributive shock is first diagnosed
Time frame: 24 hours
Cumulative Time Spent With MAP < 70 mmHg
Cumulative time spent with MAP \< 70 mmHg within the first 24 hours after distributive shock is first diagnosed
Time frame: 24 hours
Time to Extubation
Time to extubation after arrival in the ICU if distributive shock is diagnosed intraoperatively or time to extubation after distributive shock is diagnosed postoperatively
Time frame: 24 hours
Incidence of Stroke
Incidence of stroke confirmed by neurologist within 48 hours after distributive shock is first diagnosed
Time frame: 48 hours
Incidence of Acute Kidney Injury
Incidence of acute kidney injury, staged by KDIGO Creatinine criteria, within 48 hours after distributive shock is first diagnosed
Time frame: 48 hours
Incidence of New Tachyarrhythmia
Incidence of new tachyarrhythmia within the first 24 hours after distributive shock is first diagnosed
Time frame: 24 hours
Units of Blood Transfused
Units of blood transfused within first 24 hours after distributive shock is first diagnosed
Time frame: 24 hours
Fluid Overload
Fluid overload within the first 24 hours after distributive shock is first diagnosed
Time frame: 24 hours
Intensive Care Unit (ICU) Length of Stay
Total time spent in the ICU after initial diagnosis of distributive shock
Time frame: 1 year
Hospital Length of Stay
Total time spent in the hospital after diagnosis of distributive shock
Time frame: 1 year
30-day Mortality
Subject death within 30 days of diagnosis of distributive shock
Time frame: 30 days
| Milestone | Treatment | Control |
|---|---|---|
| Started | 1 | 1 |
| Completed | 1 | 1 |
| Not completed | 0 | 0 |
Total catecholamine dose for first 24 hours after distributive shock is first diagnosed
No measurements were reported for this outcome.
Cumulative time spent with MAP \< 70 mmHg within the first 24 hours after distributive shock is first diagnosed
No measurements were reported for this outcome.
Time to extubation after arrival in the ICU if distributive shock is diagnosed intraoperatively or time to extubation after distributive shock is diagnosed postoperatively
No measurements were reported for this outcome.
Incidence of stroke confirmed by neurologist within 48 hours after distributive shock is first diagnosed
No measurements were reported for this outcome.
Incidence of acute kidney injury, staged by KDIGO Creatinine criteria, within 48 hours after distributive shock is first diagnosed
No measurements were reported for this outcome.
Incidence of new tachyarrhythmia within the first 24 hours after distributive shock is first diagnosed
No measurements were reported for this outcome.
Units of blood transfused within first 24 hours after distributive shock is first diagnosed
No measurements were reported for this outcome.
Fluid overload within the first 24 hours after distributive shock is first diagnosed
No measurements were reported for this outcome.
Total time spent in the ICU after initial diagnosis of distributive shock
No measurements were reported for this outcome.
Total time spent in the hospital after diagnosis of distributive shock
No measurements were reported for this outcome.
Subject death within 30 days of diagnosis of distributive shock
No measurements were reported for this outcome.
Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment | 0/1 (0%) | 0/1 (0%) | 0/1 (0%) |
| Control | 0/1 (0%) | 0/1 (0%) | 0/1 (0%) |
Only 2 participants were enrolled in this study. Based on the low enrollment number, no data is reported here in order to protect and maintain participant privacy/confidentiality.
| Age, Categorical | Treatment | Control | Total |
|---|---|---|---|
| <=18 years | — | — | — |
| Between 18 and 65 years | — | — | — |
| >=65 years | — | — | — |
| Age, Continuous | Treatment | Control | Total |
|---|
| Sex: Female, Male | Treatment | Control | Total |
|---|---|---|---|
| Female | — | — | — |
| Male | — | — | — |
| Race (NIH/OMB) | Treatment | Control | Total |
|---|---|---|---|
| American Indian or Alaska Native | — | — | — |
| Asian | — | — | — |
| Native Hawaiian or Other Pacific Islander | — | — | — |
| Black or African American | — | — | — |
| White | — | — | — |
| More than one race | — | — | — |
| Unknown or Not Reported | — | — | — |
| Region of Enrollment(participants) | Treatment | Control | Total |
|---|
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided
Ran from Jun 2022 to primary completion in May 2024, 23 months.
Results were first posted in Apr 2026, 1 year 11 months after primary completion.
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This study is terminated, as verified in Mar 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