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The Effect of Vasopressor Therapy on Renal Perfusion in Septic Shock
Plain-language guide to NCT06234592: not phased randomized trial of Vasopressin and Angiotensin II, 45 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT06234592
- Phase
- not phased
- Status
- recruiting participants
- Start
- 2024-01-05
- Completion (planned or actual)
- 2026-01
- Participants
- 45 (estimated)
- Design
- randomized, single-blind, other
- Conditions studied
- Septic Shock; Acute Kidney Injury
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (not phased) is built around Vasopressin and Angiotensin II.
Acute kidney injury (AKI) is a common complication of septic shock and together these conditions carry a high mortality risk.
In septic patients who develop severe AKI renal cortical perfusion is deficient despite normal macrovascular organ blood flow.
It had three arms (groups): Angiotensin II Infusion (experimental), Vasopressin Infusion (experimental) and Norepinephrine Infusion (active comparator).
Standard care vasopressor therapy which recruited participants already receiving, titrated to achieve/maintain target mean arterial pressure (MAP) as directed by attending clinician.
The registry classes the interventions as drug.
Who Took Part
The registry lists 45 planned participants were the target.
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: Evidence of suspected or confirmed infection.
The full record lists 5 inclusion and 9 exclusion criteria; among the exclusions: known intolerance to sonovue™ contrast medium, vasopressin or angiotensin ii; patients receiving other vasoactive drugs in addition to norepinephrine; patients with known chronic kidney disease (ckd) stage 4 or 5 (baseline glomerular filtration rate (gfr) \<30mls/min).
How the Study Was Run
It was run as a randomized, parallel-group and single-blind study.
Random assignment meant chance, not the researchers, decided who got Vasopressin and who got the comparison, which limits bias.
Groups ran in parallel: each of the participants stayed in one arm throughout.
Only one side, usually the participants, was kept unaware of whether Vasopressin was given.
Those kept unaware of assignments: outcomes assessor.
It started in 2024-01-05 with completion listed for 2026-01.
It ran at 1 site in United Kingdom.
Its stated primary purpose is other.
What Was Measured
The main thing measured (primary outcome): Cortical mean transit time (mTT) measured in seconds (time frame: Measured at +24 hours following study vasopressor infusion starting).
It also tracked 5 secondary outcomes, for example Cortical mean transit time (mTT) measured in seconds, Cortical perfusion index (PI) measured in arbitrary units, Cortical wash in rate (WiR) measured in arbitrary units and Urinary oxygen tension (pO2) across 24 hours study period measured in millimetres of mercury (mmHg).
What This Means in Plain Language
Put simply, this is a not phased, randomized trial of Vasopressin and Angiotensin II in 45 people.
It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Vasopressin compound page and the Angiotensin II compound page, all human trials.
Our Notes on the Compounds
Vasopressin: A 9-amino-acid hormone (antidiuretic hormone) that controls water balance and blood vessel tone; used in septic shock.
Angiotensin II: An 8-amino-acid hormone that narrows blood vessels; synthetic angiotensin II (Giapreza) is used for low blood pressure in shock.
Related Pages
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.