HYDROcortisone Versus Placebo for Severe HospItal-acquired Pneumonia in Intensive Care Patients: the HYDRO-SHIP Study

NCT05354778 | Recruiting DMC

• 1 other identifier: 54214821.0.1001.0068
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

The use of corticosteroids in patients with severe community pneumonia, bacterial infection which kills lots of patients around the world, reduces the mortality of this infection. However, there are no studies with this type of drug regarding hospital-acquired pneumonia. This is the first multicenter randomized trial to test hydrocortisone plus standard therapy in critical care patients with nosocomial pneumonia. This intervention is inexpensive and may improve the outcome of those patients, besides having an acceptable side effects profile.

Conditions

Healthcare-Associated Pneumonia; Ventilator Associated Pneumonia

Keywords

Hydrocortisone; Intensive Care Unit; Pneumonia; Steroids; Critical Care

Outcome Measures

Primary Outcomes (1)

• Early Clinical Failure

  Composite outcome: Death OR Respiratory worsening OR Cardiovascular worsening

  Between days 0 and 7 for death; between days 3 and 7 for respiratory or cardiovascular worsening

Secondary Outcomes (13)

• Survival

  Days 7 and 28

• Respiratory failure

  7 days

• Septic shock

  7 days

• Time of mechanical ventilation

  7 days

• Ventilator parameters (1)

  7 days

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Normal saline 100mL every 8 hours for 5 days or until patient dies or is discharged from the intensive care unit

Drug: Placebo

Hydrocortisone

ACTIVE COMPARATOR

Hydrocortisone 100mg + normal saline 100mL every 8 hours for 5 days or until patient dies or is discharged from the intensive care unit

Drug: Hydrocortisone

Interventions

Hydrocortisone DRUG

Corticosteroid

Also known as: Solu-CORTEF

Hydrocortisone

Placebo DRUG

Normal saline only

Also known as: NS

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older
• Suspected ou confirmed case of bacterial nosocomial pneumonia (including ventilator-associated pneumonia)
• Intensive Care Unit stay
• Signed consent form (by the patient or a legal guardian)

You may not qualify if:

• Women who are pregnant, have recently given birth or are breastfeeding
• Patients who are moribund or do not have a treatment perspective
• Patients with community acquired pneumonia
• Patients with other types of pneumonia (viral - including COVID-19, fungal etc.)
• Those with pulmonary infiltrates in chest image which are not compatible with bacterial pneumonia
• Patients with adrenal insufficiency
• Patients who have a condition that demands the use of corticosteroids (acute or chronic)
• Patients allergic to hydrocortisone
• Patients with refractory septic shock (those receiving more than 0,5mcg/kg/min of norepinephrine)

Sponsors & Collaborators

• Instituto de Assistencia Medica ao Servidor Publico Estadual, Sao Paulo: lead
• Instituto do Cancer do Estado de São Paulo: collaborator
• Hospital de Câncer de Barretos: collaborator
• University of Sao Paulo: collaborator

Study Sites (1)

Hospital do Servidor Publico Estadual

São Paulo, Sao Paulo SP, 04039-901, Brazil

RECRUITING

Related Publications (21)

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• Dequin PF, Meziani F, Quenot JP, Kamel T, Ricard JD, Badie J, Reignier J, Heming N, Plantefeve G, Souweine B, Voiriot G, Colin G, Frat JP, Mira JP, Barbarot N, Francois B, Louis G, Gibot S, Guitton C, Giacardi C, Hraiech S, Vimeux S, L'Her E, Faure H, Herbrecht JE, Bouisse C, Joret A, Terzi N, Gacouin A, Quentin C, Jourdain M, Leclerc M, Coffre C, Bourgoin H, Lengelle C, Caille-Fenerol C, Giraudeau B, Le Gouge A; CRICS-TriGGERSep Network. Hydrocortisone in Severe Community-Acquired Pneumonia. N Engl J Med. 2023 May 25;388(21):1931-1941. doi: 10.1056/NEJMoa2215145. Epub 2023 Mar 21.

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MeSH Terms

Conditions

Healthcare-Associated Pneumonia; Pneumonia, Ventilator-Associated; Pneumonia

Interventions

Hydrocortisone; hydrocortisone hemisuccinate

Condition Hierarchy (Ancestors)

Cross Infection; Infections; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; 11-Hydroxycorticosteroids; Hydroxycorticosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; 17-Hydroxycorticosteroids

Study Officials

• João Manoel Silva Junior, MD

  Instituto de Assistencia Medica ao Servidor Publico Estadual, Sao Paulo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dante Raglione, MD

CONTACT

5511984471792; danraglione@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This is a multicenter, randomized, open-label clinical trial with two parallel groups: hydrocortisone and placebo. Data analyzed as "intention-to-treat".

Study Record Dates

• First Submitted: April 20, 2022
• First Posted: April 29, 2022
• Study Start: October 16, 2022
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: November 25, 2025

Record last verified: 2025-11

Locations

BR (1)