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Enrollment Challenges
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| Name | Class |
|---|---|
| La Jolla Pharmaceutical Company | INDUSTRY |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Control | Placebo Comparator | Intravenous (IV) infusion (saline) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Angiotensin II | Drug | 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) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total Catecholamine Dose | Total catecholamine dose for first 24 hours after distributive shock is first diagnosed | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Choy Lewis, MD | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University | Chicago | Illinois | 60611 | United States |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment | 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 Angiotensin II: 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) |
| FG001 | Control | Intravenous (IV) infusion (saline) Placebo: Placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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.
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment | 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 Angiotensin II: 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) |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Total Catecholamine Dose | Total catecholamine dose for first 24 hours after distributive shock is first diagnosed | 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. | Posted | 24 hours |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment | 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 Angiotensin II: 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) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Choy Lewis | Northwestern University | (312) 695-0061 | choy.lewis@northwestern.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 26, 2021 | Feb 24, 2026 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 26, 2021 | Feb 24, 2026 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D056987 | Vasoplegia |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D000804 | Angiotensin II |
| C000627694 | Giapreza |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000809 | Angiotensins |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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1:1 randomization to receive either study drug or placebo
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Study medication and matching placebo (saline) administered by IV infusion
|
| Placebo | Drug | Placebo |
|
|
| 24 hours |
| Incidence of Stroke | Incidence of stroke confirmed by neurologist within 48 hours after distributive shock is first diagnosed | 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 | 48 hours |
| Incidence of New Tachyarrhythmia | Incidence of new tachyarrhythmia within the first 24 hours after distributive shock is first diagnosed | 24 hours |
| Units of Blood Transfused | Units of blood transfused within first 24 hours after distributive shock is first diagnosed | 24 hours |
| Fluid Overload | Fluid overload within the first 24 hours after distributive shock is first diagnosed | 24 hours |
| Intensive Care Unit (ICU) Length of Stay | Total time spent in the ICU after initial diagnosis of distributive shock | 1 year |
| Hospital Length of Stay | Total time spent in the hospital after diagnosis of distributive shock | 1 year |
| 30-day Mortality | Subject death within 30 days of diagnosis of distributive shock | 30 days |
| Control |
Intravenous (IV) infusion (saline) Placebo: Placebo |
| BG002 | Total | Total of all reporting groups |
|
| Age, Continuous |
| Sex: Female, Male |
|
| Race (NIH/OMB) |
|
| Region of Enrollment | participants |
|
Intravenous (IV) infusion (saline)
Placebo: Placebo
|
| Secondary | 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 | 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. | Posted | 24 hours |
|
|
| Secondary | 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 | 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. | Posted | 24 hours |
|
|
| Secondary | Incidence of Stroke | Incidence of stroke confirmed by neurologist within 48 hours after distributive shock is first diagnosed | 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. | Posted | 48 hours |
|
|
| Secondary | Incidence of Acute Kidney Injury | Incidence of acute kidney injury, staged by KDIGO Creatinine criteria, within 48 hours after distributive shock is first diagnosed | 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. | Posted | 48 hours |
|
|
| Secondary | Incidence of New Tachyarrhythmia | Incidence of new tachyarrhythmia within the first 24 hours after distributive shock is first diagnosed | 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. | Posted | 24 hours |
|
|
| Secondary | Units of Blood Transfused | Units of blood transfused within first 24 hours after distributive shock is first diagnosed | 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. | Posted | 24 hours |
|
|
| Secondary | Fluid Overload | Fluid overload within the first 24 hours after distributive shock is first diagnosed | 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. | Posted | 24 hours |
|
|
| Secondary | Intensive Care Unit (ICU) Length of Stay | Total time spent in the ICU after initial diagnosis of distributive shock | 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. | Posted | 1 year |
|
|
| Secondary | Hospital Length of Stay | Total time spent in the hospital after diagnosis of distributive shock | 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. | Posted | 1 year |
|
|
| Secondary | 30-day Mortality | Subject death within 30 days of diagnosis of distributive shock | 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. | Posted | 30 days |
|
|
| 0 |
| 1 |
| 0 |
| 1 |
| 0 |
| 1 |
| EG001 | Control | Intravenous (IV) infusion (saline) Placebo: Placebo | 0 | 1 | 0 | 1 | 0 | 1 |
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| D013568 | Pathological Conditions, Signs and Symptoms |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |