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Recruiting Phase 2, Phase 3 NCT06155812

Multimodal Vasopressor Strategy in Septic Shock

Trial Parameters

Condition Shock, Septic
Sponsor University Medical Centre Maribor
Study Type INTERVENTIONAL
Phase Phase 2, Phase 3
Enrollment 80
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2023-12-23
Completion 2025-12
Interventions
Simultaneous administration of vasopressorsSuccessive administration of vasopressors

Brief Summary

The goal of this prospective randomized controlled trial is to compare the effects of classic stepwise vs. early balanced multimodal vasopressor strategies in septic shock.

Eligibility 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 expe

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