Investigating how vasopressor therapy affects kidney blood flow in septic shock patients
The Effect of Vasopressor Therapy on Renal Perfusion in Patients With Septic Shock - a Mechanistically Focussed Randomized Control Study
This study is testing how two medications, vasopressin and angiotensin II, affect blood flow to the kidneys in patients with septic shock and kidney problems.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 45 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | King's College Hospital NHS Trust Academic / other |
| Locations | 1 site (London) |
| Trial ID | NCT06234592 on ClinicalTrials.gov |
What this trial studies
This study examines the impact of vasopressor therapy, specifically vasopressin and angiotensin II, on renal microcirculatory perfusion in patients experiencing septic shock and acute kidney injury. It aims to understand the relationship between these therapies and kidney blood flow abnormalities that occur despite normal overall blood circulation. Patients will be monitored within 48 hours of intensive care admission, focusing on those requiring norepinephrine infusion. The findings may provide insights into the pathophysiology of septic acute kidney injury and potential therapeutic strategies.
Who should consider this trial
Good fit: Ideal candidates include patients admitted to intensive care with septic shock and evidence of acute kidney injury requiring norepinephrine.
Not a fit: Patients with chronic kidney disease stage 4 or 5, or those receiving other vasoactive drugs, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management of acute kidney injury in septic shock patients, potentially reducing mortality rates.
How similar studies have performed: Other studies have explored vasopressor effects on renal perfusion, but this specific approach is novel in the context of septic shock.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Within 48 hours of intensive care admission * Evidence of suspected or confirmed infection * Sequential Organ Failure (SOFA) score increase of 2 or more (assuming a baseline of 0 if no previous measures) * Requirement for norepinephrine infusion as the sole vasopressor agent in a dose of \>0.1mcg/kg/min * Lactate \>2mmol/L at any stage prior to randomisation Exclusion Criteria: * 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) * Patients receiving extra corporal membrane oxygenation (ECMO) * Patients with acute occlusive coronary syndromes requiring intervention * Patients with mesenteric ischaemia * Patients with a history or presence of aortic dissection or abdominal aortic aneurysm * Patients with Raynaud's syndrome or acute vaso-occlusive conditions * Pregnancy
Where this trial is running
London
- King's College Hospital — London, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Sam Hutchings
- Email: sam.hutchings@nhs.net
- Phone: 02032994957
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.