NCT06155812

Multimodal Vasopressor Strategy in Septic Shock

Simultaneous Administration of Norepinephrine, Angiotensin II, and Vasopressin in Septic Shock Patients

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 79 (actual)
• Sponsor: University Medical Centre Maribor · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not 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.

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 (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, Ang II, methylene blue or dopamine) as per clinical team decision. Initiation of inotropes (dobutamine, milrinone, levosimendan) 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, Ang II will be administered at maximum dose of 100ng/kg/min). Initiation of additional vasoactive drugs (epinephrine, methylene blue or dopamine) as per clinical team decision. Initiation of inotropes (dobutamine, milrinone, levosimendan) as per clinical team decision.

Conditions

• Shock, Septic

Interventions

Type	Name	Description
OTHER	Simultaneous administration of vasopressors	Early, simultaneous administration of norepinephrine, angiotensin II, and vasopressin.
OTHER	Successive administration of vasopressors	Administration and titration of norepinephrine and vasopressin. Administration of additional vasoactive drugs (epinephrine, methylene blue, angiotensin II or dopamine) as per clinical team. Initiation of inotropes (dobutamin, levosimendan, milrinone) as per clinical team decision.

Timeline

• Start date: 2023-12-23
• Primary completion: 2025-12-31
• Completion: 2026-02-01
• First posted: 2023-12-04
• Last updated: 2026-03-31

Locations

2 sites across 2 countries: Croatia, Slovenia