Early multimodal vasopressor strategy in septic shock (TRICYCLE)-Study protocol for a randomized controlled clinical...

Area of Science:

• Critical Care Medicine
• Pharmacology
• Clinical Trials

Background:

• Septic shock causes hypotension via persistent vasodilation and vascular hyporeactivity.
• Conventional treatment involves stepwise vasopressor escalation, often leading to poor outcomes.
• A multimodal strategy may offer a more physiologically guided approach to managing vasodilation.

Purpose of the Study:

• To compare the clinical efficacy of an early balanced multimodal vasopressor strategy versus a classic stepwise approach in septic shock.
• To investigate the impact of these strategies on renin levels and other clinical outcomes.
• To provide insights into improved management of vasodilatory states in septic shock.

Main Methods:

• Single-blind, randomized Phase II superiority trial.
• 40 patients in the control group (stepwise vasopressors: norepinephrine, then vasopressin) and 40 in the interventional group (multimodal: norepinephrine, angiotensin II, vasopressin simultaneously).
• Statistical analysis using univariate tests and generalized linear modeling.

Main Results:

• Hypothesizes that balanced multimodal vasopressor administration will significantly decrease renin levels compared to the conventional stepwise strategy.
• Secondary and exploratory outcome measures will be investigated.
• Study aims to determine if the multimodal approach leads to better clinical outcomes.

Conclusions:

• The study will test the clinical efficacy of an early multimodal vasopressor strategy in septic shock.
• Findings may contribute to improved management of vasodilatory states.
• This research addresses a critical need for optimized septic shock treatment protocols.