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| Name | Class |
|---|---|
| Innoviva Specialty Therapeutics | INDUSTRY |
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The goal of this clinical trial is to determine the safety and efficacy of Angiotensin-II in the treatment of pediatric patients in fluid refractory vasodilatory shock. The main questions it aims to answer are:
To evaluate the change in blood pressure or reduction of vasoactive requirements (norepinephrine equivalent dosing) after initiating Angiotensin II
To establish the safety and tolerability of Angiotensin-II in pediatric patients Participants will receive Angiotensin-II in addition to standard of care therapy for vasodilatory shock.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pediatric patients in vasodilatory shock | Experimental | Patients enrolled in the study who meet inclusion criteria will receive Angiotensin-II per the titration protocol. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Angiotensin-II | Drug | Angiotensin-II will be given per the titration protocol. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients who have improvement in mean arterial pressure or reduction in sum norepinephrine equivalent at Hour 2 after the start of Synthetic Angiotensin-II | Percentage (%) of patients who have improvement in mean arterial pressure (MAP, mmHg) or reduction in sum norepinephrine (NE) equivalent at Hour 2 after the start of Synthetic Angiotensin-II | From enrollment to Hour 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in MAP | Change in mean arterial pressure (mmHg) from baseline to 24 hours | From enrollment to 24 hours |
| Change in systolic blood pressure | Change in systolic blood pressure (mmHg) from baseline to 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Change in tissue oxygenation over 2 hours | Change in tissue oxygenation as defined by peripheral oxygen saturation (%) from baseline to 2 hours | From enrollment to Hour 2 |
| Change in tissue oxygenation over 24 hours |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cohen Children's Medical Center of Northwell Health | New Hyde Park | New York | 11040 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32166277 | Background | Bailey DM, Chima RS, Tidmarsh GF, Williams MD. Synthetic Human Angiotensin II in Pediatric Patients With Vasodilatory Shock: A Report on Two Patients. Crit Care Explor. 2019 Aug 15;1(8):e0036. doi: 10.1097/CCE.0000000000000036. eCollection 2019 Aug. | |
| 37711646 | Background | Tezel O, Hutson TK, Gist KM, Chima RS, Goldstein SL, Stanski NL. Utilization of Synthetic Human Angiotensin II for Catecholamine-Resistant Vasodilatory Shock in Critically Ill Children: A Single-Center Retrospective Case Series. Crit Care Explor. 2023 Sep 12;5(9):e0978. doi: 10.1097/CCE.0000000000000978. eCollection 2023 Sep. |
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| ID | Term |
|---|---|
| D000803 | Angiotensin I |
| ID | Term |
|---|---|
| D000809 | Angiotensins |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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| From enrollment to 24 hours |
| Change in diastolic blood pressure | Change in diastolic blood pressure (mmHg) from baseline to 24 hours | From enrollment to 24 hours |
| Change in concentration of serum lactate | Change in concentration of serum lactate (mmol/L) from baseline to 2 hours | From enrollment to 24 hours |
| Change in pSOFA score | Change in pSOFA score from screening to 24 hours (%) | From enrollment to 24 hours |
| Change in PRSIM-III score | Change in PRSIM-III score from screening to 24 hours (%) | From enrollment to 24 hours |
| Change in total neutrophil count | Change in total neutrophil count (cells/µL) from the start of Synthetic Angiotensin-II to 24 hours | From enrollment to 24 hours |
| Change in renal resistive index (%) | Change in renal resistive index (%) from the start of Synthetic Angiotensin-II to 24 hours after the start of Synthetic Angiotensin-II | From enrollment to 24 hours |
Change in tissue oxygenation as defined by peripheral oxygen saturation (%) from baseline to 24 hours
| From enrollment to Hour 24 |
| Change in heart rate | Change in heart rate (beats per minute) from baseline to 2 hours | From enrollment to Hour 2 |
| Change in sum norepinephrine equivalent dose over 24 hours | Change in sum norepinephrine equivalent dose (μg/kg/min) from baseline to 24 hours | From enrollment to 24 hours |
| 28-day all-cause mortality | 28-day all-cause mortality (%) | From enrollment to Day 28 |
| Number of ventilator days | Number of ventilator days | From enrollment to Day 28 |
| Ventilator free days | Number of ventilator free days | From enrollment to Day 28 |
| Days on vasoactive support | Number of days on vasoactive support | From enrollment to Day 28 |
| Change in T cell cell count | Change in T cell cell count (cells/µL) | From enrollment to Day 28 |
| Change in in serum cytokine levels | Change in in serum cytokine levels over time (pg/dL) | From enrollment to Day 28 |
| Change in renal resistive index (%) over time | Change in renal resistive index (%) over time | From enrollment to 28 days |
| Change in renal blood flow over time | Change in renal blood flow (mL/min) over time | From enrollment to 28 days |
| Change in power doppler by point of care ultrasound assessment | Change in power doppler by point of care ultrasound assessment (AU) | From enrollment to 28 days |
| Cohen Children's Medical Center |
| Queens |
| New York |
| 11101 |
| United States |
| 28528561 | Background | Khanna 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. |
| 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 |