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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

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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