Table of Contents
- Trials overview
- Trial 1: RECORDS
- Trial 2: Hydrocortisone and Fludrocortisone for Critical Illness-related Corticosteroid Insufficiency
- Main outcomes being measured
- Who participated in these studies
- What these studies are trying to answer
Trials overview
Two completed Phase 3 clinical trials studied Hydrocortisone Hemisuccinate in very sick adults in the intensive care unit (ICU).[1][2] Both studies looked at whether treatment could improve important patient outcomes such as survival, breathing support needs, and blood pressure support needs.[1][2]
These trials did not study Hydrocortisone Hemisuccinate as a general medicine for everyday use. They focused on high-risk ICU patients with severe illness, including infection-related illness and critical illness-related corticosteroid insufficiency, often called CIRCI.[1][2]
Trial 1: RECORDS
The first study was called Rapid rEcognition of COrticosteroid Resistant or sentive Sepsis – RECORDS and had the ID NCT04280497.[1] It was a completed Phase 3 interventional trial with 1,800 enrolled participants.[1]
This trial studied ICU patients with proven or suspected infection as the main diagnosis.[1] The study compared Hydrocortisone Hemisuccinate plus fludrocortisone with placebo, and it also included placebo versions of the study drugs for comparison.[1]
The main goal was to compare the effect of Hydrocortisone Hemisuccinate plus fludrocortisone against placebo on a combined outcome of death or ongoing organ problems at 90 days.[1] The trial also looked at whether patients stayed free from vasopressors and mechanical ventilation, which are treatments used to support blood pressure and breathing.[1]
Trial 2: Hydrocortisone and Fludrocortisone for Critical Illness-related Corticosteroid Insufficiency
The second study was NCT04404400 and was also a completed Phase 3 interventional trial.[2] It enrolled 3,276 participants, making it the larger of the two studies.[2]
This trial focused on critically ill patients suffering from CIRCI, which means critical illness-related corticosteroid insufficiency.[2] The study compared Hydrocortisone Hemisuccinate plus fludrocortisone with placebo, and it also used tetracosactide in the trial design.[2]
The primary endpoint was the number of ventilator- and vasopressor-free days up to day 30.[2] In simple terms, the researchers wanted to know how many days within the first 30 days after randomization the patient was alive, not on a breathing machine, and not receiving medicines to raise blood pressure.[2]
Main outcomes being measured
These trials used outcomes that matter in intensive care because they show how well a patient is recovering from a severe illness.[1][2] One study used a 90-day combined outcome that included death, organ dysfunction, and time free from vasopressors and mechanical ventilation.[1]
The second study focused on the number of ventilator- and vasopressor-free days by day 30.[2] In both studies, deaths counted as zero days for these recovery measures, which makes the endpoint stricter and more focused on real recovery.[2]
Who participated in these studies
Both studies included adults who were already in the ICU and were seriously ill.[1][2] One trial included patients with proven or suspected infection as the main diagnosis, while the other included patients with CIRCI.[1][2]
Because the trials were done in the ICU, the people enrolled were not routine outpatients. They were patients needing close monitoring and advanced hospital care.[1][2]
What these studies are trying to answer
These trials are trying to answer a practical question: can Hydrocortisone Hemisuccinate, especially when paired with fludrocortisone, help very sick ICU patients recover better than placebo or other study treatments?[1][2]
The studies are not focused on mild illness. They are designed for severe ICU conditions where survival, organ function, breathing support, and blood pressure support are major concerns.[1][2]
