The Effect of phoSPHocreatine on Medical Emergency Team (MET) Treated Patients: a Randomized Clinical Trial Protocol

What this Trial Is About

Researchers are studying hospitalized patients who experience unexpected health deteriorations requiring intervention by a Medical Emergency Team (MET). These events often result in intensive care unit (ICU) admissions and long hospital stays. The trial aims to evaluate whether adding phosphocreatine (PCr), a natural molecule linked to improved outcomes in acute cardiac and other organ failures, to standard care can improve patient recovery and reduce hospital stay length. Participants are randomly assigned to receive either phosphocreatine or a saline placebo for up to three days. Dosage varies based on kidney function: patients without renal failure receive multiple doses starting with two 4-gram doses on day 0 and then 2 grams twice daily on days 1 and 2; those with a history of renal failure or acute kidney injury receive fewer doses accordingly. The placebo group receives a matching saline solution on the same schedule. This is a double-blind, randomized, placebo-controlled Phase 3 clinical trial. During the study, participants are monitored for up to 30 days, with outcomes such as days alive and out of hospital, cognitive function, arrhythmia rates, ICU admissions, and mortality recorded. Safety and effectiveness are assessed through these measures. The total participation includes treatment administration and follow-up evaluations, ensuring detailed data collection on patient recovery and clinical status.

The Effect of phoSPHocreatine on mEdical Emergency Team (Met) tREated Patients