Multimodal Vasopressor Strategy in Septic Shock

Last updated: March 18, 2025
Sponsor: University Medical Centre Maribor
Overall Status: Active - Recruiting

Phase

2/3

Condition

Low Blood Pressure (Hypotension)

Treatment

Simultaneous administration of vasopressors

Successive administration of vasopressors

Clinical Study ID

NCT06155812
IRP-2023/01-03
  • Ages > 18
  • All Genders

Study 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

Inclusion Criteria:

  • Adult patients (≥18 years).

  • Sepsis (an acute change in total Sequential Organ Failure Assessment (SOFA) score ≥2points consequent to infection) with persisting hypotension requiring vasopressorsto maintain MAP ≥65 mm Hg and having a serum lactate level >2 mmol/L despiteadequate 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 toremain present for at least the initial 72 hours of study.

  • Patients must have cardiac index (CI) >2.3 L/min/m2 (measured by bedsideechocardiography, pulse contour cardiac output (PiCCO) or Swan-Ganz catheter).

Exclusion

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 initiationof 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.

Study Design

Total Participants: 80
Treatment Group(s): 2
Primary Treatment: Simultaneous administration of vasopressors
Phase: 2/3
Study Start date:
December 23, 2023
Estimated Completion Date:
November 30, 2026

Study 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 (administered at a fixed dose of 0.03 IE/min). If MAP remains < 65 mmHg, norepinephrine will be titrated above dose of 0.5 mcg/kg/min until MAP ≥ 65 mmHg. Initiation of additional vasoactive drugs (epinephrine, methylene blue, dobutamine, or dopamine) as per clinical team decision.

EXPERIMENTAL GROUP(Balanced multimodal vasopressor administration):

Early, simultaneous start of norepinephrine, angiotensin II and vasopressin at equivalent starting doses (equivalent to approximately 0.05 mcg/kg/min of norepinephrine). Increments of 0.05 mcg/kg/min of equivalent doses of all three vasopressors every 3-5 min until MAP ≥ 65 mmHg is reached (vasopressin will be administered at a maximum dose of 0.03 IE/min, AT II will be administered at maximum dose of 100ng/kg/min).

Connect with a study center

  • University Hospital Centre Zagreb

    Zagreb,
    Croatia

    Active - Recruiting

  • Medical intensive care unit UMC Maribor

    Maribor, 2000
    Slovenia

    Active - Recruiting

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