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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05354778
Recruitment Status : Not yet recruiting
First Posted : April 29, 2022
Last Update Posted : September 8, 2022
Sponsor:
Collaborators:
Instituto do Cancer do Estado de São Paulo
Hospital Samaritano Paulista
Hospital de Câncer de Barretos
Fundação Faculdade Regional de Medicina de São José do Rio Preto
University of Sao Paulo
Information provided by (Responsible Party):
João manoel Silva Junior, Instituto de Assistencia Medica ao Servidor Publico Estadual, Sao Paulo

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 will be 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.

Condition or disease Intervention/treatment Phase
Healthcare-Associated Pneumonia Ventilator Associated Pneumonia Drug: Hydrocortisone Drug: Placebo Not Applicable

Detailed Description:

Introduction and Objectives: the use of corticosteroids in patients with severe community pneumonia, bacterial infection which kills lots of patients around the world, reduces morbimortality. However, to our knowledge, there are no studies with steroids for patients in intensive care with nosocomial pneumonia, among which those with ventilator associated pneumonia, infections which carry a high mortality rate. The treatment for those diseases involves intensive care and antibiotics, but there is a need for inexpensive, adjuvant therapies which improve the outcome for those patients. Therefore, the objective of this study is to compare hydrocortisone versus placebo, both with standard therapy, in the outcome of critical care patients diagnosed with nosocomial pneumonia.

Methods: multicenter randomized, open-label, controlled trial, with two parallel groups: hydrocortisone or placebo, associated with nosocomial pneumonia's standard treatment. Patients with viral or other etiologies of pneumonia will be excluded, as well as corticosteroids chronical users, or patients with conditions which demand this type of therapy. Intravenous 100mg of hydrocortisone and normal saline (the placebo) will be tested every eight hours for five days or until intensive care unit (ICU) discharge or until the patient dies. The sample will be of 180 patients, 90 in each group, in different ICUs in Brazil. The primary outcome will be early clinical failure between the third and seventh days of the patient's inclusion in the study. The secondary outcomes will be survival and mortality in both groups, need for intubation, mechanical ventilation, vasoactive drugs and dialysis, lengths of stay in the hospital and in the ICU and radiological progression. Moreover, we will analyze adverse events and there will be a safety interim analysis when 25% of the whole sample is recruited, which may interrupt the study in case of a high frequency of such events (> 15% grade 3 or 4 as defined by the FDA). Finally, we will conduct an efficacy interim analysis when 50% of the sample is recruited. The study will be interrupted only if there is a statistical significant difference regarding the primary outcome with p < 0.001 (Haybittle-Peto criteria).

Discussion, risks, and benefits: this will be 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. Weighing the benefits and risks of this study, as well as its strengths and potential weaknesses, it is believed that its realization is justified, in addition to bringing important advances in the field of intensive care.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This will be a multicenter, randomized, double-blind clinical trial with two parallel groups: hydrocortisone and placebo. Data will be analyzed as "intention-to-treat".
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: HYDROcortisone Versus Placebo for Severe HospItal-acquired Pneumonia in Intensive Care Patients: the HYDRO-SHIP Study
Estimated Study Start Date : October 2022
Estimated Primary Completion Date : January 2024
Estimated Study Completion Date : July 2024


Arm Intervention/treatment
Placebo Comparator: Placebo
Normal saline 100mL every 8 hours for 5 days or until patient dies or is discharged from the intensive care unit
Drug: Placebo
Normal saline only
Other Name: NS

Active Comparator: Hydrocortisone
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
Corticosteroid
Other Name: Solu-CORTEF




Primary Outcome Measures :
  1. Early Clinical Failure [ Time Frame: Between days 3 and 7 ]
    Composite outcome: Death OR Respiratory worsening OR Cardiovascular worsening


Secondary Outcome Measures :
  1. Survival [ Time Frame: Days 7 and 28 ]
    In the intensive care unit and in the hospital

  2. Respiratory failure [ Time Frame: 7 days ]
    Need for mechanical ventilation

  3. Septic shock [ Time Frame: 7 days ]
    Need for vasoactive drugs

  4. Time of mechanical ventilation [ Time Frame: 7 days ]
    Number of days patients require invasive ventilation support

  5. Ventilator parameters [ Time Frame: 7 days ]
    Positive end expiratory pressure (PEEP)

  6. Ventilator parameters [ Time Frame: 7 days ]
    Inspired oxygen fraction (FiO2)

  7. Arterial blood gas analysis [ Time Frame: 7 days ]
    Partial pressure of oxygen (PaO2)

  8. Respiratory condition [ Time Frame: 7 days ]
    Horowitz index for lung function (P/F ratio) - obtained from PaO2/FiO2

  9. Time of vasoactive drugs use [ Time Frame: 7 days ]
    Dosage and types of vasoactive drugs

  10. Length of stay [ Time Frame: 28 days ]
    In the Intensive Care Unit and in the hospital

  11. Need for renal substitution therapy [ Time Frame: 7 days ]
    Need for dialysis

  12. Radiological worsening [ Time Frame: 7 days ]
    Progression of image in the chest X-ray image

  13. Adverse effects [ Time Frame: 7 days ]
    psychosis, insomnia, hyperglycemia, hypernatremia, rhabdomyolysis, gastrointestinal bleeding and critical myopathy illness



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 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)

Exclusion Criteria:

  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05354778


Contacts
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Contact: Dante Raglione, MD 5511984471792 danraglione@gmail.com

Locations
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Brazil
Hospital do Servidor Publico Estadual
Sao Paulo, Sao Paulo SP, Brazil, 04039-901
Sponsors and Collaborators
Instituto de Assistencia Medica ao Servidor Publico Estadual, Sao Paulo
Instituto do Cancer do Estado de São Paulo
Hospital Samaritano Paulista
Hospital de Câncer de Barretos
Fundação Faculdade Regional de Medicina de São José do Rio Preto
University of Sao Paulo
Investigators
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Principal Investigator: João Manoel Silva Junior, MD Instituto de Assistencia Medica ao Servidor Publico Estadual, Sao Paulo
Publications:

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Responsible Party: João manoel Silva Junior, Principal Investigator, Instituto de Assistencia Medica ao Servidor Publico Estadual, Sao Paulo
ClinicalTrials.gov Identifier: NCT05354778    
Other Study ID Numbers: 54214821.0.1001.0068
First Posted: April 29, 2022    Key Record Dates
Last Update Posted: September 8, 2022
Last Verified: September 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by João manoel Silva Junior, Instituto de Assistencia Medica ao Servidor Publico Estadual, Sao Paulo:
Hydrocortisone
Intensive Care Unit
Pneumonia
Steroids
Critical Care
Additional relevant MeSH terms:
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Pneumonia
Pneumonia, Ventilator-Associated
Healthcare-Associated Pneumonia
Respiratory Tract Infections
Infections
Lung Diseases
Respiratory Tract Diseases
Cross Infection
Iatrogenic Disease
Disease Attributes
Pathologic Processes
Hydrocortisone
Hydrocortisone hemisuccinate
Anti-Inflammatory Agents