Status:
COMPLETED
Evaluation of the Role of Hydrocortisone Either Alone or Combined With Fludrocortisone in the Outcome of Septic Shock in Adults
Lead Sponsor:
Ain Shams University
Conditions:
Septic Shock
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
During Infection, oflfending microbes interact with the host immune system producing a downstream inflammatory cascade involving cytokines and other mediators, which in turn triggers a systemic respon...
Eligibility Criteria
Inclusion
- This study will be conducted on patients between 18-80 years old, both sexes who are suffering from septic shock and have any of the following any of 1, 2, or 3 criteria
- CLINICAL EVIDENCE OF INFECTION WITHIN THE PREVIOUS 72 HOURS OF ICU ADMISSION (any of a, b, or c)
- Presence of polymorphonuclear cells in a normally sterile body fluid.
- Culture or Gram stain of blood, sputum, urine or normally sterile body fluid positive for a pathogenic micro-organism.
- Focus of infection identified by visual inspection (e.g. ruptured bowel with the presence of free air or bowel contents in the abdomen found at the time of surgery, wound with purulent drainage).
- Sepsis-related organ failure assessment (SOFA) score of 3 or 4 (on a scale of 0 to 4 for each of six organ systems) for at least 2 organs and at least 6 hours (Singer et al., 2016).
- Vasopressors Therapy ( norepinephrine , epinephrine , or any other vasopressors at a dose of ≥ 0.25 µg / kg / minute ) for at least 6 hours to maintain a systolic blood pressure of at least 90 mm Hg or mean blood pressure of at least 65 mm Hg (Singer et al., 2016).
Exclusion
- Refusal of patient or legal guardian to consent to participate in the study.
- Pregnancy and lactation.
- Gastrointestinal Bleeding
Key Trial Info
Start Date :
September 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2019
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT04492280
Start Date
September 1 2018
End Date
September 1 2019
Last Update
July 30 2020
Active Locations (1)
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1
Mona A Ammar
Cairo, Egypt