Comparing Protocolized Reduction of Non-resuscitation Fluids Versus Usual Care in Adults With Septic Shock

What this Trial Is About

Researchers are evaluating the effects of a restrictive approach to giving non-resuscitation fluids compared to usual care in adult patients with septic shock. The goal is to understand both the beneficial and harmful impacts of limiting these fluids in this critical condition. This trial is led by Region Skane and involves adult patients diagnosed with septic shock under specific clinical criteria. Participants are assigned randomly to one of two groups. One group receives non-resuscitation fluids following a strict protocol that starts within two hours of randomization and continues during their ICU stay, up to 90 days. This protocol includes stopping maintenance fluids if fluid balance is positive and the patient is not dehydrated, adjusting intravenous and enteral fluids to correct electrolyte disturbances, and using concentrated intravenous medications. The other group receives fluids according to usual local care routines, which involve maintenance fluids at about 1 mlkgh unless otherwise specified and glucose at a maximum concentration of 10%, with medications concentrated per local protocol. Participants are monitored during their ICU stay and followed for up to 90 days to assess mortality, complications, and days free from mechanical ventilation. Cognitive function and health-related quality of life are evaluated six months after inclusion. The study uses a triple-blind randomized design to compare outcomes between the protocolized fluid reduction and usual care. Regular assessments and follow-up visits will track participant status and safety throughout the study period.

Protocolized Reduction of Non-resuscitation Fluids Versus Usual Care in Septic Shock Patients