Distributive ShockPhase 4NCT04904562
Angiotensin II for Distributive Shock
A Phase 4 study testing Angiotensin II in people with Distributive Shock, run by Northwestern University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Distributive Shock
- What is being tested?
- Angiotensin II
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2022to 1 Jul 2024
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients (18 years of age or older)
- Onset of distributive shock within 48 hours after heart transplantation or VAD placement. Distributive shock defined as MAP less than 55mmHg on CPB, MAP less than 70mmHg before or after CPB, or systemic vascular resistance (SVR) less than 800 dynes/cm/sec5 with cardiac index (CI) greater than 2.0L/min/m2 and clinically determined euvolemia.
Who cannot join
- Patients without distributive shock,
- Women who are pregnant or breastfeeding.
- Patients who do not receive the study drug as a first line agent for distributive shock
- Allergy to angiotensin II, angiotensin II or another vasopressor being used at the time of presentation to the operating room
- Preexisting distributive shock
- Preexisting thromboembolic disease
- Patients who are unwilling to provide consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Angiotensin II as a First-line Vasopressor for Distributive Shock During or After Heart Transplantation or Durable Left Ventricular Assist Device Implantation: A Pilot Study
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:
- Group A: Heart Transplant (10 control, 10 treatment)
- Group B: LVAD implant (10 control, 10 treatment)
Read the detailed description
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).
- Conditions
- Distributive Shock
- Being tested
- Angiotensin II, Placebo
- Keywords
- Vasoplegia
- Medical subject headings
- Vasoplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Angiotensin IIDrug
Also called Giapreza
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)
PlaceboDrug
Also called Saline solution
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Active comparator | 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 Receives: Drug: Angiotensin II |
| Control | Placebo comparator | Intravenous (IV) infusion (saline) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Catecholamine Dose
Total catecholamine dose for first 24 hours after distributive shock is first diagnosed
Measured: 24 hours
Secondary outcomes (10)
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
Measured: 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
Measured: 24 hours
Incidence of Stroke
Incidence of stroke confirmed by neurologist within 48 hours after distributive shock is first diagnosed
Measured: 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
Measured: 48 hours
Incidence of New Tachyarrhythmia
Incidence of new tachyarrhythmia within the first 24 hours after distributive shock is first diagnosed
Measured: 24 hours
Units of Blood Transfused
Units of blood transfused within first 24 hours after distributive shock is first diagnosed
Measured: 24 hours
Fluid Overload
Fluid overload within the first 24 hours after distributive shock is first diagnosed
Measured: 24 hours
Intensive Care Unit (ICU) Length of Stay
Total time spent in the ICU after initial diagnosis of distributive shock
Measured: 1 year
Hospital Length of Stay
Total time spent in the hospital after diagnosis of distributive shock
Measured: 1 year
30-day Mortality
Subject death within 30 days of diagnosis of distributive shock
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2021
- Study start1 Jun 2022
- Primary completion1 May 2024
- Study completion1 Jul 2024
Why it stopped: Enrollment Challenges
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Distributive ShockStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1:1 randomization to receive either study drug or placebo
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- La Jolla Pharmaceutical Company
- Responsible party
- Sponsor
- Investigators
- Choy Lewis, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04904562
- Sponsor's protocol ID
- STU00211528
- Status last verified
- Mar 2026
- First submitted
- 12 May 2021
- Last updated
- 13 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Angiotensin II as a First-line Vasopressor for Distributive Shock During or After Heart Transplantation or Durable Left Ventricular Assist Device Implantation: A Pilot Study
- ClinicalTrials.gov ID
- NCT04904562
- Acronym / sponsor ID
- STU00211528
- Conditions
- Distributive Shock
- Keywords
- Vasoplegia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enrollment Challenges
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- La Jolla Pharmaceutical Company
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 27 May 2021 (actual)
- Results
- Posted 13 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Group A: Heart Transplant (10 control, 10 treatment)
- Group B: LVAD implant (10 control, 10 treatment)
Detailed description
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- 1:1 randomization to receive either study drug or placebo
| Arm | Type | Receives |
|---|---|---|
| Treatment | Active comparator | Drug: Angiotensin IIAngiotensin II administered as an intravenous (IV) infusion will be increased every 5 minutes by 5-10ng/kg/min increments up to 80ng/kg/min |
| Control | Placebo comparator | Drug: PlaceboIntravenous (IV) infusion (saline) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients (18 years of age or older)
- Onset of distributive shock within 48 hours after heart transplantation or VAD placement. Distributive shock defined as MAP less than 55mmHg on CPB, MAP less than 70mmHg before or after CPB, or systemic vascular resistance (SVR) less than 800 dynes/cm/sec5 with cardiac index (CI) greater than 2.0L/min/m2 and clinically determined euvolemia.
Key exclusion criteria (7 listed)
- Patients without distributive shock,
- Women who are pregnant or breastfeeding.
- Patients who do not receive the study drug as a first line agent for distributive shock
- Allergy to angiotensin II, angiotensin II or another vasopressor being used at the time of presentation to the operating room
- Preexisting distributive shock
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 IIAlso: GiaprezaAngiotensin 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) | Drug | Treatment |
| PlaceboAlso: Saline solutionPlacebo | Drug | Control |
Primary outcome
Total Catecholamine Dose
Time frame: 24 hours
Total catecholamine dose for first 24 hours after distributive shock is first diagnosed
10 secondary outcomes
Cumulative Time Spent With MAP < 70 mmHg
Time frame: 24 hours
Time to Extubation
Time frame: 24 hours
Incidence of Stroke
Time frame: 48 hours
Incidence of Acute Kidney Injury
Time frame: 48 hours
Incidence of New Tachyarrhythmia
Time frame: 24 hours
Units of Blood Transfused
Time frame: 24 hours
Fluid Overload
Time frame: 24 hours
Intensive Care Unit (ICU) Length of Stay
Time frame: 1 year
Hospital Length of Stay
Time frame: 1 year
30-day Mortality
Time frame: 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
Related trials for Distributive Shock
RecruitingObservational study
Angiotensin II Stress Test. Renin Kinetics During Treatment of Vasoplegic Shock With Angiotensin II.
Shock, Vasoplegic Syndrome
RecruitingObservational study
Hemodynamic Effects of Norepinephrine Reduction on Critical Closing Pressure in Distributive Shock
Distributive Shock, Hemodynamic Assessment
RecruitingPhase 3
Efficacy and Safety of Angiotensin II Injection Versus Placebo in Patients With Refractory Distributed Shock
Vasodilatory Shock
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. This study is not recruiting at the moment.
Choy Lewis, MD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Angiotensin II in people with Distributive Shock, run by Northwestern University at 1 site in United States.
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 2 inclusion and 7 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: stopped early, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 13 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Total Catecholamine Dose (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Apr 2026.