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Multimodal Vasopressor Strategy in Septic Shock
RECRUITINGPhase 2/3Sponsored by University Medical Centre Maribor
Actively Recruiting
PhasePhase 2/3
SponsorUniversity Medical Centre Maribor
Started2023-12-23
Est. completion2025-12
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT06155812
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
Age: 18 Years+Healthy volunteers accepted
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.
Conditions2
DiabetesShock, Septic
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Actively Recruiting
PhasePhase 2/3
SponsorUniversity Medical Centre Maribor
Started2023-12-23
Est. completion2025-12
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT06155812