Can adding a second steroid improve survival in severe sepsis?
NCT ID NCT00368381
First seen Aug 31, 2026 · Last updated Sep 01, 2026 · Updated 1 time
Summary
This trial compares two treatments for people with severe sepsis who also have adrenal insufficiency, a condition where the adrenal glands do not make enough cortisol. Researchers test whether giving fludrocortisone along with hydrocortisone works better than hydrocortisone alone. The main goal is to see if the combination reduces deaths within the first 28 days. Participants are adults in intensive care with confirmed adrenal insufficiency and severe sepsis.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Hydrocortisone plus fludrocortisone
- What this could lead to
- If the combination works, it could offer a better way to treat adrenal insufficiency in severe sepsis, potentially lowering the risk of death within the first month.
- What could go wrong
- This is a small, early-stage trial, and the added benefit of fludrocortisone may not be significant. Steroids carry risks like increased infection or blood sugar issues.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Start date
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Sep 2006
- Finished
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Sep 2009
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Males and non-pregnant females \> 18 years of age * Patients admitted and/or pending admission to the intensive care unit * Positive corticotropin stimulation test (Basal cortisol level of ≤ 34 μg/dL with Δ ≤ 9 μg/dL after administration of 250 mg of cosyntropin) Patient satisfies criteria for severe sepsis Infection - one or more of the following criteria * Documented or Suspected - positive culture results (from blood, sputum, urine, etc.) * Anti-Infective Therapy - patient is receiving antibiotic, antifungal, or other anti-infective therapy * Pneumonia - documentation of pneumonia (x-ray, etc.) * WBCs - WBCs found in normally sterile .uid (urine, CSF, etc.) * Perforated Viscus - perforation of hollow organ (bowel) SIRS - two or more of the following * Temperature \> 38° or \< 36° * Heart rate \> 90 bpm * Respiratory rate above 20 breaths per minute * WBC \> 14,000/mm3 , \< 4000/mm3, or \>10% Bands Acute organ dysfunction - one or more of the following * Cardiovascular - SBP \< 90 mmHg or MAP \< 70 mmHg despite 20 mL/kg of fluid resuscitation * Respiratory - PaO2/FiO2 ratio \< 250, PEEP \> 7.5, or require mechanical ventilation * Renal - low urine output (eg, \<0.5 mL/kg/hr for 1 hour despite 20mL/kg of fluid resuscitation, increased creatinine (\>50% increase from baseline) or require acute dialysis * Hematologic - low platelet count (\< 100,000/mm3) or PT/PTT \> upper limit of normal * Metabolic - low pH with high lactate (eg, pH \< 7.30 and plasma lactate \> upper limit of normal * Hepatic - liver enzymes \> 2x upper limit of normal * CNS - altered consciousness or reduced Glasgow Coma Score Exclusion Criteria: * Patients who respond to the short cosyntropin stimulation test(Δ \> 9mg/dL) * Pregnancy or breast-feeding mother * Evidence of acute myocardial infarction, meningitis, pulmonary embolism * AIDS (CD4 \< 200 cells/mL) * Contraindications for corticosteroids * Formal indication for corticosteroids (specifically including patients with known adrenal insufficiency) * Onset of shock \> 24 hours * Etomidate administration within the 6 hours preceding randomization * Cardiac arrest prior to randomization.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
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Other studies related to the condition(s) this trial covers.
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