Synthetic Angiotensin II/Giapreza in Pediatric Patients With Refractory Hypotension

Summary

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. * The study team will then monitor the patient's vital signs, blood work, and for any potential side effects from the drug. * An ultrasound will be performed to look at blood flow through the kidney in the setting of vasodilatory shock. * A follow up phone call to check in with the patient will be performed 28 days after enrollment.

Timeline

Start

2025-09-09

Primary completion

2030-06

Completion

2030-06

Publications

• 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.
• 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.
• 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.

Drugs

Indications

No indication recorded.