Phase 4
Completed N=28
Renin and Renal Biomarker Response to Angiotensin II
Source: ClinicalTrials.gov NCT04558359 ↗Enrolled (actual)
28
Serious AEs
0.0%
Results posted
Sep 2024
Primary outcomePrimary: Change in Plasma Renin Levels — -15; 69; -6; 26 pg/mL
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
Septic shock continues to exert a large economic burden around the world. Several developments have occurred that lead to the current study. First, angiotensin II is the newest FDA approved vasopressor agent indicated for use in vasodilatory shock. Several subgroups from the approval trial have indicated that angiotensin II may confer a survival benefit in certain conditions, including those patients requiring continuous renal replacement therapy, those with altered angiotensin I: angiotensin II ratios, and most recently, those with elevated renin levels (which may serve as a surrogate for dysfunctional angiotensin 1: angiotensin II ratios). This open-label, sequential period pilot study will evaluate angiotensin II and biomarker response (renin) in the treatment of septic shock.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Plasma Renin Levels |
-15; 69; -6; 26; 41 | — |
| SECONDARY Change in Plasma Cystatin C |
-254; -143; 99; -124; -196 | — |
| SECONDARY Days to Discontinuation of Catecholamines |
0.9; 3.5 | — |
| SECONDARY ICU Length of Stay |
4.3; 7.2 | — |
| SECONDARY Number of Participants With In-hospital Mortality |
9; 9 | — |
| SECONDARY Renal Replacement Therapy-free Days |
0; 21 | — |
| SECONDARY Number of Participants Experiencing Prespecified Safety Outcomes |
0; 0 | — |
| SECONDARY Change in Plasma Neutrophil Gelatinase-associated Lipocalin (NGAL) |
10; 93; 18; 201; -21 | — |
Eligibility Criteria
Inclusion Criteria
- Medical ICU admission
- Septic shock
- Norepinephrine requirement = 0.15 mcg/kg/min for = 30 minutes (if cirrhosis, norepinephrine requirement = 0.1 mcg/kg/min for = 30 minutes)
- Kidney Disease Improving Global Outcomes stage 1 or greater Acute Kidney Injury
Exclusion Criteria
- Prisoner
- Pregnancy
- Acute occlusive coronary syndrome requiring intervention or acute myocardial infarction of any degree
- Purely cardiogenic shock (no distributive component)
- Mesenteric ischemia
- Acute ischemic stroke
- Hemorrhagic shock
- Active treatment of hepatorenal syndrome targeting a Mean Arterial Pressure = 65 mm Hg
- Planned withdrawal of care within next 24 hours or no escalation of care
- Patient enrolled in an interventional study
- High likelihood of medical futility in using this drug:
- 3 or more vasopressors required to sustain MAP
- Sustained norepinephrine equivalents > 0.5 mcg/kg/min
- COVID-19 positive, or high suspicion of COVID-19
Data sourced from ClinicalTrials.gov (NCT04558359). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.