Angiotensin II in the Perioperative Management of Hypotension in Kidney Transplant Recipients

Plain-language guide to NCT04529005: phase 4 interventional trial of Angiotensin II, post-surgical inflammation and surgery recovery, 20 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT04529005
Phase: phase 4
Status: completed
Start: 2020-08-13
Completion (planned or actual): 2021-08-01
Participants: 20 (actual)
Design: na, open label (everyone knows who gets what), treatment
Conditions studied: Shock, Surgical; Shock; Hypotension and Shock; Kidney Transplant; Complications; Intraoperative Hypotension; Postoperative Hypotension
Results posted: yes

What This Study Did, in Plain Language

What Was Tested

In this phase 4 trial, researchers set out to test Angiotensin II for post-surgical inflammation and surgery recovery.

It had 1 arm (groups): Angiotensin II (Giapreza) (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 20 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Adult patients \> 18 years of age. Receiving deceased donor kidney transplant. Intraoperative or postoperative distributive shock (according to hospital and study protocol) requiring vasopressor support.

The full record lists 4 inclusion and 8 exclusion criteria; among the exclusions: pregnant patients (they would be excluded from receiving a transplant); history of mesenteric ischemia; history of aortic dissection.

How the Study Was Run

The set-up was single-group and open-label.

Nothing was hidden in this open-label Angiotensin II study: the post-surgical inflammation and surgery recovery participants and staff both knew the treatment.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2020-08-13 with completion listed for 2021-08-01.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Duration of ATII Vasopressor Usage in the Intraoperative Setting (time frame: Duration of usage during the transplant surgery - presented in hours).

It also tracked 6 secondary outcomes, for example Number (and Percentage) of Patients With Arrhythmias, Number (and Percentage) of Patients With Peripheral/Visceral Ischemia, Number (and Percentage) of Patients With Thrombosis, Number (and Percentage) of Patients With Fungal Infections, Number (and Percentage) of Patients With Hyperglycemia and Number (and Percentage) of Patients With Delayed Graft Function.

What This Means in Plain Language

Put simply, this is a phase 4 trial of Angiotensin II in 20 people with post-surgical inflammation and surgery recovery.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Angiotensin II compound page, Post-surgical inflammation and surgery recovery research.

Our Notes on the Compound

Angiotensin II: An 8-amino-acid hormone that narrows blood vessels; synthetic angiotensin II (Giapreza) is used for low blood pressure in shock.

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.