Study of Albumin and Crystalloid Fluids to Improve Survival in Adults with Septic Shock

What this Trial Is About

Septic shock is a severe condition with high mortality worldwide. Researchers are evaluating whether giving albumin together with crystalloid fluids early in treatment improves survival compared to using crystalloid fluids alone. This study is a phase 4 randomized controlled trial designed to assess the benefits of albumin in initial fluid resuscitation for patients with septic shock. Participants are randomly assigned to one of two groups. The treatment group receives 200 cc of 20% human albumin plus 15 cc per kg of crystalloid fluid over 1 to 2 hours. The control group receives 30 cc per kg of crystalloid fluid alone, following usual care practices. Physicians can choose the type of crystalloid fluid used, such as balanced fluid or isotonic saline. During the study, participants survival is tracked with the primary outcome being 28-day all-cause mortality. Additional outcomes include 7-day, 90-day, ICU, and hospital mortality, organ failure scores, ICU stay length, ventilator and vasopressor-free days, fluid amounts given, kidney therapy needs, and safety parameters. The study monitors participants from enrollment and continues until final outcome assessments, ensuring comprehensive follow-up for up to 90 days.

Albumin and Crystalloid Administration in Septic Shock