Comparing vasopressor strategies in septic shock treatment
Simultaneous Administration of Norepinephrine, Angiotensin II, and Vasopressin in Septic Shock Patients
This study is testing two different ways to use medications for treating septic shock to see which one helps stabilize patients better.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Medical Centre Maribor Academic / other |
| Locations | 2 sites (Zagreb and 1 other locations) |
| Trial ID | NCT06155812 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of two different vasopressor strategies in treating septic shock. The control group will receive a classic stepwise administration of norepinephrine and vasopressin, while the experimental group will receive an early balanced multimodal approach with simultaneous administration of norepinephrine, angiotensin II, and vasopressin. The study will monitor the mean arterial pressure (MAP) and other clinical parameters to determine which strategy is more effective in stabilizing patients. It involves adult patients who meet specific criteria related to sepsis and hypotension.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with septic shock requiring vasopressors to maintain blood pressure.
Not a fit: Patients expected to die within 24 hours or those with pregnancy are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management of septic shock, potentially reducing mortality rates.
How similar studies have performed: Other studies have explored vasopressor strategies, but this specific multimodal approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patients (≥18 years). * Sepsis (an acute change in total Sequential Organ Failure Assessment (SOFA) score ≥2 points consequent to infection) with persisting hypotension requiring vasopressors to maintain MAP ≥65 mm Hg and having a serum lactate level \>2 mmol/L despite adequate volume resuscitation (20-30ml/kg in 3 hours). * Vasopressor requirement of ≥0,15 μg/kg/min equivalent of norepinephrine base. * Patients are required to have central venous access and an arterial line present, and these are expected to remain present for at least the initial 72 hours of study. * Patients are required to have an urinary catheter present, and it is expected to remain present for at least the initial 72 hours of study. * Patients must have cardiac index (CI) \>2.3 L/min/m2 (measured by bedside echocardiography, pulse contour cardiac output (PiCCO) or Swan-Ganz catheter). Exclusion Criteria: * Death expected \<24 hours. * Pregnancy (suspected or confirmed). * Surgery expected for source of infection. * Inter-hospital transfer expected during first 72 hours of hospitalization. * Liver failure with a Model for End-Stage Liver Disease (MELD) score of ≥30. * Patients with acute mesenteric ischemia or a history of mesenteric ischemic. * Patients with Raynaud's phenomenon, systemic sclerosis or vasospastic disease. * Patients with active bleeding and an anticipated need (within 48 hours of initiation of the study) for transfusion of \>4 units of packed red blood cells. * Patients with a known allergy to mannitol. * Patients on veno-arterial (VA) ECMO.
Where this trial is running
Zagreb and 1 other locations
- University Hospital Centre Zagreb — Zagreb, Croatia (Recruiting)
- Medical intensive care unit UMC Maribor — Maribor, Slovenia (Recruiting)
Study contacts
- Principal investigator: Žiga Kalamar, MD — University Medical Centre Maribor
- Study coordinator: Žiga Kalamar, MD
- Email: ziga.kalamar94@gmail.com
- Phone: +386 2 321 2471
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.