Status:
RECRUITING
Multimodal Vasopressor Strategy in Septic Shock
Lead Sponsor:
University Medical Centre Maribor
Conditions:
Shock, Septic
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
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.
Detailed Description
CONTROL GROUP(Classic stepwise vasopressor administration): Patients will be started on norepinephrine with increases of 0.05-0.1 mcg/kg/min up to 0.5 mcg/kg/min, followed by vasopressin (administere...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 23 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2026
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06155812
Start Date
December 23 2023
End Date
November 1 2026
Last Update
July 3 2025
Active Locations (2)
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1
University Hospital Centre Zagreb
Zagreb, Croatia
2
Medical intensive care unit UMC Maribor
Maribor, Slovenia, 2000