In short
Clinical trials are studying Hydrocortisone in many different patient groups, including people with sepsis, cardiac arrest, adrenal insufficiency, cancer, skin disease, and PTSD. These studies look at how Hydrocortisone is used in treatment plans and whether it helps with outcomes like survival, symptoms, recovery, or quality of life.
Key points
- Clinical trials of Hydrocortisone are studying a wide range of conditions, from emergency care like cardiac arrest and sepsis to long-term problems such as adrenal insufficiency, PTSD, and inflammatory disease. Most studies are Phase 2 or Phase 3, with a few Phase 4 or early-phase trials. The target groups include adults, children, teens, and infants, depending on the condition. Many trials test Hydrocortisone as part of a treatment bundle or compared with placebo. The main outcomes often focus on survival, symptoms, organ recovery, quality of life, or complication rates.
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. The studies ask whether Hydrocortisone helps people recover better, survive longer, or have fewer complications in serious illness, surgery, inflammatory disease, and adrenal problems.
Some trials test Hydrocortisone alone, while others use it together with other treatments such as vasopressin, fludrocortisone, octreotide, or standard cancer or immune therapies. Several studies compare Hydrocortisone with placebo, which is an inactive treatment used to make the comparison fair.
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.
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. These trials mainly ask whether Hydrocortisone can lower complications after surgery.
Hydrocortisone is also studied in adrenal disorders such as glucocorticoid-induced adrenal insufficiency, primary adrenal insufficiency, and adrenal symptoms after stopping glucocorticoids. In these studies, the goal is often to improve fatigue, quality of life, or symptoms during stress.
Several trials involve immune and inflammatory diseases, including rheumatoid arthritis, idiopathic inflammatory myopathies, atopic dermatitis, ulcerative pyoderma gangrenosum, and congenital adrenal hyperplasia. Hydrocortisone also appears in studies in blood cancers, prostate cancer, colorectal cancer, and acute leukemia, usually as part of a larger treatment plan.
Some trials are in mental health or brain-related research, including PTSD, acute stress, and moral decision-making under stress. These studies are trying to understand whether Hydrocortisone changes stress response, fear learning, or symptom severity.
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. There are also Phase 4 studies, which usually look at treatment use in real-world settings after earlier research has already been done.
Many of the trials are randomized, meaning people are assigned by chance to different groups. 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.
Several studies are interventional, so the researchers actively give a treatment and then measure the results. 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.
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.
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. These measures show whether patients are living longer and whether their organs are recovering.
In surgery trials, endpoints include major complications, postoperative pancreatic fistula, acute renal failure, pulmonary complications, and the need for noradrenaline. These are important because they show whether the operation led to serious problems after surgery.
In adrenal and quality-of-life studies, the endpoints include fatigue scales, AddiQoL scores, and symptoms of adrenal insufficiency. In inflammatory disease trials, endpoints include response scores such as ACR20, EASI-75, and TIS improvement, which measure disease improvement in specific conditions.
In cancer and leukemia studies, endpoints include overall response rate, progression-free survival, event-free survival, complete remission, and minimal residual disease negativity. These endpoints show whether the cancer is responding to treatment and how long the benefit lasts.
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.
Other studies include children and adolescents, such as trials in pediatric atopic dermatitis, pediatric acute leukemia, and childhood or young-adult leukemia. One trial is specifically in infants under one year with acute lymphoblastic leukemia.
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. This means a person must match the trial’s condition and other entry rules to join.
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. The trial is listed as suspended in one record and authorised in another record with the same NCT ID.
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. Its dual primary endpoints are 28-day all-cause mortality and days alive without life-supportive therapies at day 28.
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.
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.
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.
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. These studies often measure response, safety, or progression-free survival rather than Hydrocortisone alone.
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. They also check whether Hydrocortisone can improve daily symptoms like fatigue, stress-related problems, or quality of life.
Because the trials study many different diseases, the results from one study cannot be applied to every patient. Each trial has its own target group, treatment plan, and main outcome, so the details matter.