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

January 17, 2024 updated by: João manoel Silva Junior, Instituto de Assistencia Medica ao Servidor Publico Estadual, Sao Paulo
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Brazil
    • Sao Paulo SP
      • Sao Paulo, Sao Paulo SP, Brazil, 04039-901
        • Recruiting
        • Hospital do Servidor Publico Estadual
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Solu-CORTEF

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Early Clinical Failure
Time Frame: Between days 3 and 7
Composite outcome: Death OR Respiratory worsening OR Cardiovascular worsening
Between days 3 and 7

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival
Time Frame: Days 7 and 28
In the intensive care unit and in the hospital
Days 7 and 28
Respiratory failure
Time Frame: 7 days
Need for mechanical ventilation
7 days
Septic shock
Time Frame: 7 days
Need for vasoactive drugs
7 days
Time of mechanical ventilation
Time Frame: 7 days
Number of days patients require invasive ventilation support
7 days
Ventilator parameters
Time Frame: 7 days
Positive end expiratory pressure (PEEP)
7 days
Ventilator parameters
Time Frame: 7 days
Inspired oxygen fraction (FiO2)
7 days
Arterial blood gas analysis
Time Frame: 7 days
Partial pressure of oxygen (PaO2)
7 days
Respiratory condition
Time Frame: 7 days
Horowitz index for lung function (P/F ratio) - obtained from PaO2/FiO2
7 days
Time of vasoactive drugs use
Time Frame: 7 days
Dosage and types of vasoactive drugs
7 days
Length of stay
Time Frame: 28 days
In the Intensive Care Unit and in the hospital
28 days
Need for renal substitution therapy
Time Frame: 7 days
Need for dialysis
7 days
Radiological worsening
Time Frame: 7 days
Progression of image in the chest X-ray image
7 days
Adverse effects
Time Frame: 7 days
psychosis, insomnia, hyperglycemia, hypernatremia, rhabdomyolysis, gastrointestinal bleeding and critical myopathy illness
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto de Assistencia Medica ao Servidor Publico Estadual, Sao Paulo

Collaborators

University of Sao Paulo
Instituto do Cancer do Estado de São Paulo
Hospital de Câncer de Barretos

Investigators

  • Principal Investigator: João Manoel Silva Junior, MD, Instituto de Assistencia Medica ao Servidor Publico Estadual, Sao Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 16, 2022

Primary Completion (Estimated)

April 1, 2024

Study Completion (Estimated)

July 1, 2024

Study Registration Dates

First Submitted

April 20, 2022

First Submitted That Met QC Criteria

April 26, 2022

First Posted (Actual)

April 29, 2022

Study Record Updates

Last Update Posted (Estimated)

January 19, 2024

Last Update Submitted That Met QC Criteria

January 17, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 54214821.0.1001.0068

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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