CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 20 enrolled
Drug / intervention
Angiotensin IIdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04529005
NCT04529005Phase 4Completed

Angiotensin II in the Perioperative Management of Hypotension in Kidney Transplant

University of Illinois at Chicago·interventional·Posted Aug 27, 2020·Updated Dec 21, 2022

In Brief

A Phase 4 clinical trial evaluating Angiotensin II for Shock, Surgical and 5 related conditions. Completed, enrolled 20 participants across 1 site.

Detailed Summary

The current standard of catecholamine vasopressor management of perioperative hypotension in kidney transplant patients carries significant risks and falls short in many ways. Currently, there is an absence in the scientific literature and research describing the hemodynamic effectiveness and safety of novel pharmacologic agents such as angiotensin II (Giapreza - Ang II) in perioperative kidney transplant patients. Phase 3 registration trials have demonstrated the superior safety and efficacy of Ang II (Giapreza) in distributive shock patients compared to traditional vasopressor agents and the novel mechanism of action may provide additional protection in renal transplant patients. The pilot study entails giving informed and consenting kidney transplant recipients Ang II (Giapreza) as their first vasopressor if the need for vasopressors emerge either intraoperatively or postoperatively in kidney transplant recipients. The primary objective is to evaluate the safety and hemodynamic effects of Ang II (Giapreza) in the renal transplant population.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 4CompletedFinished
202120222023202420252026
First PostedAug 27, 2020
Enrollment StartAug 13, 2020
Primary CompletionAug 1, 2021
TodayJul 2, 2026
Enrollment to primary: 12 monthsPosted 5.8 years ago

Interventions

Angiotensin IIdrug

If intraoperative or postoperative hypotension occurs (e.g. SBP \< 120 mmHg) and the attending surgeon and/or attending anesthesiologist deems vasopressor therapy to be necessary, angiotensin II (Giapreza) will be the first vasopressor used for management.