Table of contents
- Overview of Hydrocortisone trials
- Conditions being studied
- Trial phases and study designs
- Main endpoints researchers measure
- Who can take part
- Important Hydrocortisone studies
- What these studies mean in plain language
Overview of Hydrocortisone trials
Across the trial data, Hydrocortisone is being studied in many different clinical settings, not as a drug monograph but as part of research questions about patient outcomes.[1] The studies ask whether Hydrocortisone helps people recover better, survive longer, or have fewer complications in serious illness, surgery, inflammatory disease, and adrenal problems.[1][2]
Some trials test Hydrocortisone alone, while others use it together with other treatments such as vasopressin, fludrocortisone, octreotide, or standard cancer or immune therapies.[1][2] Several studies compare Hydrocortisone with placebo, which is an inactive treatment used to make the comparison fair.[1][2]
Conditions being studied
The trials cover a broad mix of conditions. Emergency and intensive care studies include cardiac arrest, sepsis, and post-resuscitation syndrome, where the focus is on survival and recovery after a life-threatening event.[1]
Other studies look at surgical patients, especially people having high-risk cardiac surgery or pancreatoduodenectomy, which is a major operation on the pancreas and nearby intestine.[1][2] These trials mainly ask whether Hydrocortisone can lower complications after surgery.[1]
Hydrocortisone is also studied in adrenal disorders such as glucocorticoid-induced adrenal insufficiency, primary adrenal insufficiency, and adrenal symptoms after stopping glucocorticoids.[1] In these studies, the goal is often to improve fatigue, quality of life, or symptoms during stress.[1]
Several trials involve immune and inflammatory diseases, including rheumatoid arthritis, idiopathic inflammatory myopathies, atopic dermatitis, ulcerative pyoderma gangrenosum, and congenital adrenal hyperplasia.[1][2] Hydrocortisone also appears in studies in blood cancers, prostate cancer, colorectal cancer, and acute leukemia, usually as part of a larger treatment plan.[1][2]
Some trials are in mental health or brain-related research, including PTSD, acute stress, and moral decision-making under stress.[1] These studies are trying to understand whether Hydrocortisone changes stress response, fear learning, or symptom severity.[1]
Trial phases and study designs
Most Hydrocortisone studies in the source data are Phase 2 or Phase 3 trials, which are later stages of research that usually test whether a treatment works and how safe it is in larger groups.[1] There are also Phase 4 studies, which usually look at treatment use in real-world settings after earlier research has already been done.[1]
Many of the trials are randomized, meaning people are assigned by chance to different groups.[1] Some are double-blind and placebo-controlled, which means neither the participants nor the study team knows who gets the active treatment during the trial, helping reduce bias.[1]
Several studies are interventional, so the researchers actively give a treatment and then measure the results.[1] A few trials are low-intervention or open-label, meaning the study design is less strict or both the team and the participant know what treatment is given.[1]
Main endpoints researchers measure
The main endpoints vary by condition, but many focus on outcomes that matter to patients and families. In emergency studies, endpoints include 30-day survival, day-30 neurological outcome, and survival or recovery after cardiac arrest.[1]
In sepsis and intensive care studies, researchers measure 28-day mortality, days alive without life-supportive therapies, and organ failure scores such as the SOFA score.[1] These measures show whether patients are living longer and whether their organs are recovering.[1]
In surgery trials, endpoints include major complications, postoperative pancreatic fistula, acute renal failure, pulmonary complications, and the need for noradrenaline.[1] These are important because they show whether the operation led to serious problems after surgery.[1]
In adrenal and quality-of-life studies, the endpoints include fatigue scales, AddiQoL scores, and symptoms of adrenal insufficiency.[1] In inflammatory disease trials, endpoints include response scores such as ACR20, EASI-75, and TIS improvement, which measure disease improvement in specific conditions.[1]
In cancer and leukemia studies, endpoints include overall response rate, progression-free survival, event-free survival, complete remission, and minimal residual disease negativity.[1] These endpoints show whether the cancer is responding to treatment and how long the benefit lasts.[1]
Who can take part
Eligibility depends on the study, and the source data show that Hydrocortisone trials include a wide age range. Some trials are for adults only, such as studies in sepsis, cardiac surgery, PTSD, Addison’s Disease, or prostate cancer.[1]
Other studies include children and adolescents, such as trials in pediatric atopic dermatitis, pediatric acute leukemia, and childhood or young-adult leukemia.[1] One trial is specifically in infants under one year with acute lymphoblastic leukemia.[1]
Some studies are limited to very specific groups, such as kidney transplant recipients in intensive care, people with glucocorticoid-induced adrenal insufficiency, or patients with high-risk pancreatoduodenectomy.[1] This means a person must match the trial’s condition and other entry rules to join.[1]
Important Hydrocortisone studies
The VAST-A trial is a Phase 3 study in cardiac arrest patients, comparing standard adrenaline alone with a combination that includes vasopressin and steroids, and it measures survival at 30 days.[1] The trial is listed as suspended in one record and authorised in another record with the same NCT ID.[1]
The PALETTE study is a Phase 2 sepsis trial in children and adults, and Hydrocortisone is one of several study treatments being compared with usual care.[1] Its dual primary endpoints are 28-day all-cause mortality and days alive without life-supportive therapies at day 28.[1]
The PD-HYDRA trial is a Phase 4 study in people having pancreatoduodenectomy, and it tests Hydrocortisone infusions against placebo to see whether it lowers post-operative pancreatic fistula of grade B or worse within 90 days.[1]
The RESCUE study is a Phase 3 placebo-controlled trial in people with glucocorticoid-induced adrenal insufficiency, and it focuses on fatigue during stress using smartphone-based ecological momentary assessment, which means repeated symptom checks in daily life.[1]
The SHIELD trial is a Phase 2 PTSD study after trauma exposure, and it asks whether Hydrocortisone lowers PTSD symptom severity at 3 months using the CAPS-5 score.[1]
In oncology, Hydrocortisone appears in trials such as studies in acute leukemia, myelodysplastic syndrome, lymphoma, and prostate cancer, usually as part of supportive care or a treatment combination.[1] These studies often measure response, safety, or progression-free survival rather than Hydrocortisone alone.[1]
What these studies mean in plain language
In simple terms, these trials are trying to find out where Hydrocortisone helps most, whether that is in a medical emergency, after surgery, during severe infection, or in long-term hormone problems.[1] They also check whether Hydrocortisone can improve daily symptoms like fatigue, stress-related problems, or quality of life.[1]
Because the trials study many different diseases, the results from one study cannot be applied to every patient.[1] Each trial has its own target group, treatment plan, and main outcome, so the details matter.[1]
