Can adding a second steroid improve survival in severe sepsis?

NCT ID NCT00368381

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled This study
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Start date

Sep 2006

Finished

Sep 2009

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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.

adrenocortical insufficiency infectious disease with sepsis Sepsis Systemic Inflammatory Response Syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

More trials for these conditions

Other studies related to the condition(s) this trial covers.