Septic ShockPhase 4NCT04492280
Evaluation of the Role of Hydrocortisone Either Alone or Combined With Fludrocortisone in the Outcome of Septic Shock in Adults
A Phase 4 study testing Hydrocortisone in people with Septic Shock, run by Ain Shams University at 1 site in Egypt.
Trial 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 response. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Septic Shock
- What is being tested?
- Hydrocortisone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2018to 1 Sep 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- Refusal of patient or legal guardian to consent to participate in the study.
- Pregnancy and lactation.
- Gastrointestinal Bleeding
Trial locations and contacts
1 site in 1 country.
About this study
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 response. The resultant effects linclude vasodilation, increased vascular permeability, myocardial depression, and impairment of the coagulation cascade, resulting in global imbalance of systemic oxygen supply and demand. During the late stage of sepsis, immunosuppression predominates, leading to multi-organ dysfunction and further clinical deterioration .
Sepsis is defined as life-threatening organ dysfunction caused by a dysregulated host response to infection with two or three on Quick Sepsis-related organ failure assessment score (qSOFA). Septic shock is defined as the presence of sepsis and refractory hypotension to fluid management. Vasopressors are needed to maintain systolic blood pressure more than 90mmHg or mean blood pressure more than 65 mmHg .
Read more
Experimental and Clinical evidence suggests that sepsis is associated with dysregulated response of Hypothalamic-pituitary-adrenal axis that may involve any of the steps from cortisol production to cortisol use by cells .
Glucocorticoid therapy for the treatment of septic shock remains controversial, with conflicting evidence regarding a mortality benefit. It has been used in patients with septic shock who remained hypotensive after fluid and vasopressor resuscitation.
Fludrocortisone is a corticosteroid and acts as a powerful mineralocorticoid along with some additional but comparatively very weak glucocorticoid activity. Relative to cortisol, it is to 10 times the glucocorticoid potency but 250 to 800 times the mineralocorticoid potency .
Fludrocortisone is added to hydrocortisone to provide additional mineralocorticoid potency. The rationale for adding mineralocorticoid treatment is that an experimental sepsis study showed marked nuclear factor NF-κB mediated down regulation of vascular mineralocorticoid receptors .
Corticosteroids attenuate inflammation in various organs an effect partly related to inhibition of nuclear factor NF-κB. Improve cardiovascular function by restoring effective blood volume through increased mineralocorticoid activity and by increasing systemic vascular resistance through vascular α-Adrenergic responsiveness and reduces inflammation-mediated vasodilation .
- Conditions
- Septic Shock
- Being tested
- Hydrocortisone
- Medical subject headings
- Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HydrocortisoneDrug
Also called Fludrocortisone
After approval of the ethical committee of faculty of Medicine Ain Shams University and obtaining a written informed consent from all patients or their legal guardians, the study will be conducted on 66 patients subdivided randomly via computer closed envelopes method into 3 equal groups, 22 patients for each group; group HF (hydrocortisone \& fludrocortisone), group H (hydrocortisone) and group C (control group).
| Study group | Role | What they receive |
|---|---|---|
| 1. Group H | Active comparator | These patients will receive standard therapy for sepsis plus Hydrocortisone (Solucortef®, E.I.P.I.co. under license of Pfizer) at dose 50mg every 6 hours by Intra venous route. Receives: Drug: Hydrocortisone |
| 2. Group HF | Active comparator | These patients will receive standard therapy for sepsis plus Hydrocortisone (Solucortef®) at dose of 50mg every 6 hours by Intra venous route and Fludrocortisone (Cortilon®, Amoun) 50 Microgram once daily by nasogastric tube for one week Receives: Drug: Hydrocortisone |
| 3. Group C | Placebo comparator | These patients will receive standard therapy for sepsis. Receives: Drug: Hydrocortisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
• Mortality rate due to septic shock as a cause.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2020
- Study start1 Sep 2018
- Primary completion1 Sep 2019
- Study completion1 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mona Ammar, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04492280
- Sponsor's protocol ID
- 176/2018
- Status last verified
- Jul 2020
- First submitted
- 17 Jul 2020
- Last updated
- 30 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Role of Hydrocortisone Either Alone or Combined With Fludrocortisone in the Outcome of Septic Shock in Adults
- ClinicalTrials.gov ID
- NCT04492280
- Acronym / sponsor ID
- 176/2018
- Conditions
- Septic Shock
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 1 Sep 2019 (actual)
- Study completion
- 1 Sep 2019 (actual)
- First posted
- 30 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 response. The resultant effects linclude vasodilation, increased vascular permeability, myocardial depression, and impairment of the coagulation cascade, resulting in global imbalance of systemic oxygen supply and demand. During the late stage of sepsis, immunosuppression predominates, leading to multi-organ dysfunction and further clinical deterioration .
Sepsis is defined as life-threatening organ dysfunction caused by a dysregulated host response to infection with two or three on Quick Sepsis-related organ failure assessment score (qSOFA). Septic shock is defined as the presence of sepsis and refractory hypotension to fluid management. Vasopressors are needed to maintain systolic blood pressure more than 90mmHg or mean blood pressure more than 65 mmHg .
Experimental and Clinical evidence suggests that sepsis is associated with dysregulated response of Hypothalamic-pituitary-adrenal axis that may involve any of the steps from cortisol production to cortisol use by cells .
Glucocorticoid therapy for the treatment of septic shock remains controversial, with conflicting evidence regarding a mortality benefit. It has been used in patients with septic shock who remained hypotensive after fluid and vasopressor resuscitation.
Fludrocortisone is a corticosteroid and acts as a powerful mineralocorticoid along with some additional but comparatively very weak glucocorticoid activity. Relative to cortisol, it is to 10 times the glucocorticoid potency but 250 to 800 times the mineralocorticoid potency .
Fludrocortisone is added to hydrocortisone to provide additional mineralocorticoid potency. The rationale for adding mineralocorticoid treatment is that an experimental sepsis study showed marked nuclear factor NF-κB mediated down regulation of vascular mineralocorticoid receptors .
Corticosteroids attenuate inflammation in various organs an effect partly related to inhibition of nuclear factor NF-κB. Improve cardiovascular function by restoring effective blood volume through increased mineralocorticoid activity and by increasing systemic vascular resistance through vascular α-Adrenergic responsiveness and reduces inflammation-mediated vasodilation .
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1. Group H | Active comparator | Drug: HydrocortisoneThese patients will receive standard therapy for sepsis plus Hydrocortisone (Solucortef®, E.I.P.I.co. under license of Pfizer) at dose 50mg every 6 hours by Intra venous route. |
| 2. Group HF | Active comparator | Drug: HydrocortisoneThese patients will receive standard therapy for sepsis plus Hydrocortisone (Solucortef®) at dose of 50mg every 6 hours by Intra venous route and Fludrocortisone (Cortilon®, Amoun) 50 Microgram once daily by nasogastric tube for one week |
| 3. Group C | Placebo comparator | Drug: HydrocortisoneThese patients will receive standard therapy for sepsis. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
- 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).
Key exclusion criteria (3 listed)
- Refusal of patient or legal guardian to consent to participate in the study.
- Pregnancy and lactation.
- Gastrointestinal Bleeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HydrocortisoneAlso: FludrocortisoneAfter approval of the ethical committee of faculty of Medicine Ain Shams University and obtaining a written informed consent from all patients or their legal guardians, the study will be conducted on 66 patients subdivided randomly via computer closed envelopes method into 3 equal groups, 22 patients for each group; group HF (hydrocortisone \& fludrocortisone), group H (hydrocortisone) and group C (control group). | Drug | 1. Group H, 2. Group HF, 3. Group C |
Primary outcome
• Mortality rate due to septic shock as a cause.
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2020.
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Sepsis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Hydrocortisone in people with Septic Shock, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
• Mortality rate due to septic shock as a cause. (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2020.