In short
Clinical trials of Hydrocortisone Hemisuccinate are studying its use in very sick ICU patients, especially those with sepsis or critical illness-related corticosteroid insufficiency (CIRCI). These studies look at whether treatment improves survival, reduces organ problems, and lowers the need for ventilation or vasopressors.
Key points
- Clinical trials of Hydrocortisone Hemisuccinate are focused on very sick adults in the ICU. One Phase 3 study looks at patients with proven or suspected infection, while another studies critically ill patients with CIRCI. The trials mainly test Hydrocortisone Hemisuccinate with fludrocortisone against placebo or other comparators. Researchers are measuring outcomes such as survival, organ dysfunction, and days free from mechanical ventilation and vasopressors. Both studies are completed and include large patient groups. The overall goal is to see whether treatment improves recovery in severe critical illness.
Trials overview
Two completed Phase 3 clinical trials studied Hydrocortisone Hemisuccinate in very sick adults in the intensive care unit (ICU). Both studies looked at whether treatment could improve important patient outcomes such as survival, breathing support needs, and blood pressure support needs.
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.
Trial 1: RECORDS
The first study was called Rapid rEcognition of COrticosteroid Resistant or sentive Sepsis - RECORDS and had the ID NCT04280497. It was a completed Phase 3 interventional trial with 1,800 enrolled participants.
This trial studied ICU patients with proven or suspected infection as the main diagnosis. The study compared Hydrocortisone Hemisuccinate plus fludrocortisone with placebo, and it also included placebo versions of the study drugs for comparison.
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. The trial also looked at whether patients stayed free from vasopressors and mechanical ventilation, which are treatments used to support blood pressure and breathing.
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. It enrolled 3,276 participants, making it the larger of the two studies.
This trial focused on critically ill patients suffering from CIRCI, which means critical illness-related corticosteroid insufficiency. The study compared Hydrocortisone Hemisuccinate plus fludrocortisone with placebo, and it also used tetracosactide in the trial design.
The primary endpoint was the number of ventilator- and vasopressor-free days up to day 30. 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.
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. One study used a 90-day combined outcome that included death, organ dysfunction, and time free from vasopressors and mechanical ventilation.
The second study focused on the number of ventilator- and vasopressor-free days by day 30. In both studies, deaths counted as zero days for these recovery measures, which makes the endpoint stricter and more focused on real recovery.
Who participated in these studies
Both studies included adults who were already in the ICU and were seriously ill. One trial included patients with proven or suspected infection as the main diagnosis, while the other included patients with CIRCI.
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.
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?
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.