Septic ShockPhase 3STASISNCT04134403
Steroids, Thiamine and Ascorbic Acid in Septic Shock
A Phase 3 study testing STASIS in people with Septic Shock, run by Baqiyatallah Medical Sciences University.
Trial summary
The objective of this project is to determine if in patients admitted to the hospital with septic shock (population), does treatment with a bundle including hydrocortisone, thiamine, and ascorbic acid improve in-hospital or 28-day mortality (primary outcomes) or surrogate markers of illness severity including: (1) ICU… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Septic Shock
- What is being tested?
- STASIS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2019to 1 Dec 2020
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Septic shock admitted to the ICU within 24 hours as defined by SEPSIS-3
- SEPSIS-3 defines septic shock as sepsis with the following criteria despite adequate fluid resuscitation:
- Vasopressor required to maintain MAP ≥ 65 AND
- Serum lactate level >2.0 mmol/L
- Age ≥ 18 years
- Non-pregnant
- Ability to consent with medical capacity or legally authorized representative (LAR) consent
Who cannot join
- Age < 18 years
- Pregnant defined by negative serum HCG in all females
- Patients with limitation of care (i.e. DNR)
- Known G6PD deficiency
- Excluding primary admission diagnosis including the following:
- Acute stroke
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- Acute coronary syndrome
- Active gastrointestinal bleed
- Burn
- Trauma
- Prisoners
- >1 episode of sepsis in hospital admission
- Vasopressor use prior to randomization for more than 24 hours
Trial locations and contacts
No sites are listed yet.
Andrew C Miller, MD contact
About this study
Official title: Steroids, Thiamine and Ascorbic Acid Supplementation in Septic Shock (STASIS): A Prospective Crossover Randomized Controlled Study
The objective of this project is to determine if in patients admitted to the hospital with septic shock (population), does treatment with a bundle including hydrocortisone, thiamine, and ascorbic acid improve in-hospital or 28-day mortality (primary outcomes) or surrogate markers of illness severity including: (1) ICU or hospital length-of-stay, (2) duration of invasive mechanical ventilation, (3) duration of vasopressor administration, (4) incidence and severity of ICU delirium, and (5) illness severity (secondary outcomes).
Read the detailed description
This trial is designed as a multi-center prospective, double-blinded, randomized controlled study. The objective of this project is to determine if in patients admitted to the hospital with septic shock (population), does treatment with a bundle including hydrocortisone, thiamine, and ascorbic acid improve in-hospital or 28-day mortality (primary outcomes) or surrogate markers of illness severity including: (1) ICU or hospital length-of-stay, (2) duration of invasive mechanical ventilation, (3) duration of vasopressor administration, (4) incidence and severity of ICU delirium, and (5) illness severity (secondary outcomes). The calculated sample size is 80. Subjects will be followed for 28 days or until hospital discharge.
Patients eligible for inclusion must be admitted with septic shock (as defined by SEPSIS-3) requiring vasopressors to maintain MAP ≥ 65 AND serum lactate level >2 mmol/L after adequate fluid resuscitation (generally recognized at 30 ml/kg crystalloid unless contraindicated as deemed by treating clinician) within the first three hours.
The exclusion criteria are: age < 18 years, pregnant, patients with limitation of care (i.e. do not resuscitate [DNR]), known Glucose-6-Phosphate Dehydrogenase (G6PD) Deficiency, and vasopressor use for > 24 hours prior to study enrollment.
Patients in Arm 1 will randomized to receive usual care + hydrocortisone, thiamine and ascorbic acid. Arm 2 will be randomized to receive usual care alone. Crossover is not allowed. If a patient is randomized into study Arm 2, the treating physician may decide to administer study medications if they feel it is in the best interest of the patient. In this case the patient will continue to be analyzed in their assigned arm on an intention to treat basis. Source of participants will be in-hospital and Emergency Department patients.
- Conditions
- Septic Shock
- Being tested
- STASIS
- Keywords
- Steroids, Thiamine, Ascorbic Acid Supplementation, Septic Shock, STASIS
- Medical subject headings
- Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STASISDrug
Hydrocortisone sodium succinate, 50 mg, every 6 hours, 7 days or until ICU discharge Thiamine, 200 mg, every 12 hours, 4 days or until ICU discharge Ascorbic acid, 1,500 mg, every 6 hours, 4 days or until ICU discharge
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Intervention | Experimental | Arm will be those that are randomized to receive usual care plus hydrocortisone, thiamine and ascorbic acid. Receives: Drug: STASIS |
| Arm 2: Usual care | No intervention | Arm will be those that are randomized to receive usual care alone. |
What is being measured
The primary outcome is the main question the study is designed to answer.
In-hospital or 28-day mortality rate
To determine if the addition of hydrocortisone, thiamine and ascorbic acid to standard care versus standard care in septic shock confers an in-hospital and 28-day mortality benefit
Measured: 28 days or discharge (whichever comes first)
Secondary outcomes (10)
Illness Severity (Change in SOFA Score)
To determine if the addition of hydrocortisone, thiamine and ascorbic acid to standard care in septic shock confers more rapid improvements in illness severity
Measured: 72 hours
Hospital length-of-stay ICU LOS Duration of intubation
To determine if the addition of hydrocortisone, thiamine and ascorbic acid to standard care in septic shock confers improved hospital length-of-stay metrics
Measured: 1 year or discharge (whichever comes first)
ICU length-of-stay
To determine if the addition of hydrocortisone, thiamine and ascorbic acid to standard care in septic shock confers improved ICU length-of-stay metrics
Measured: 90 days or discharge (whichever comes first)
Vasopressor duration (days)
To determine if the addition of hydrocortisone, thiamine and ascorbic acid to standard care in septic shock confers improvement in vasopressor requirements
Measured: 28 days or discharge (whichever comes first)
ICU delerium (CAM-ICU score)
To determine if the addition of hydrocortisone, thiamine and ascorbic acid to standard care in septic shock changes the incidence or severity of ICU delerium
Measured: 28 days or discharge (whichever comes first)
Mechanical ventilation
To determine if the addition of hydrocortisone, thiamine and ascorbic acid to standard care in septic shock changes the incidence or duration of invasive mechanical ventilation.
Measured: 28 days or discharge (whichever comes first)
Cardiac arrest
To determine if the addition of hydrocortisone, thiamine and ascorbic acid to standard care in septic shock changes the incidence of cardiac arrest or need for cardiopulmonary resuscitation
Measured: 28 days or discharge (whichever comes first)
Renal replacement therapy
- determine if the addition of hydrocortisone, thiamine and ascorbic acid to standard care in septic shock changes the incidence of cardiac arrest or need for renal replacement therapy.
Measured: 28 days or discharge (whichever comes first)
C-reactive protein
To determine if the addition of hydrocortisone, thiamine and ascorbic acid to standard care in septic shock changes the biochemical profiling in septic patients including a more rapid improvement in C-reactive protein
Measured: 28 days or discharge (whichever comes first)
Procalcitonin
- determine if the addition of hydrocortisone, thiamine and ascorbic acid to standard care in septic shock changes the biochemical profiling in septic patients including a more rapid improvement in procalcitonin.
Measured: 28 days or discharge (whichever comes first)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2019
- Study start1 Dec 2019 (estimated)
- Primary completion1 Nov 2020 (estimated)
- Study completion1 Dec 2020 (estimated)
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.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A Prospective Parallel Randomized Controlled clinical Study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baqiyatallah Medical Sciences University
- Sponsor type
- University, hospital or other
- Collaborators
- Hamadan University of Medical Science, Tehran University of Medical Sciences
- Responsible party
- Principal investigator, Amir Vahedian-Azimi, Baqiyatallah Medical Sciences University
- Investigators
- Amir Vahedian-Azimi, PhD, Principal investigator, Baqiyatallah University of Medical ScienecsAndrew C Miller, MD, Principal investigator, East Carolina University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04134403
- Sponsor's protocol ID
- STASIS
- Acronym
- STASIS
- Status last verified
- Oct 2019
- First submitted
- 18 Sep 2019
- Last updated
- 22 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Steroids, Thiamine and Ascorbic Acid Supplementation in Septic Shock (STASIS): A Prospective Crossover Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04134403
- Acronym / sponsor ID
- STASIS / STASIS
- Conditions
- Septic Shock
- Keywords
- Steroids, Thiamine, Ascorbic Acid Supplementation, Septic Shock, STASIS
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Baqiyatallah Medical Sciences UniversityUniversity, hospital or other
- Collaborators
- Hamadan University of Medical Science, Tehran University of Medical Sciences
- Study start
- 1 Dec 2019 (estimated)
- Primary completion
- 1 Nov 2020 (estimated)
- Study completion
- 1 Dec 2020 (estimated)
- First posted
- 22 Oct 2019 (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.
The objective of this project is to determine if in patients admitted to the hospital with septic shock (population), does treatment with a bundle including hydrocortisone, thiamine, and ascorbic acid improve in-hospital or 28-day mortality (primary outcomes) or surrogate markers of illness severity including: (1) ICU or hospital length-of-stay, (2) duration of invasive mechanical ventilation, (3) duration of vasopressor administration, (4) incidence and severity of ICU delirium, and (5) illness severity (secondary outcomes).
Detailed description
This trial is designed as a multi-center prospective, double-blinded, randomized controlled study. The objective of this project is to determine if in patients admitted to the hospital with septic shock (population), does treatment with a bundle including hydrocortisone, thiamine, and ascorbic acid improve in-hospital or 28-day mortality (primary outcomes) or surrogate markers of illness severity including: (1) ICU or hospital length-of-stay, (2) duration of invasive mechanical ventilation, (3) duration of vasopressor administration, (4) incidence and severity of ICU delirium, and (5) illness severity (secondary outcomes). The calculated sample size is 80. Subjects will be followed for 28 days or until hospital discharge.
Patients eligible for inclusion must be admitted with septic shock (as defined by SEPSIS-3) requiring vasopressors to maintain MAP ≥ 65 AND serum lactate level >2 mmol/L after adequate fluid resuscitation (generally recognized at 30 ml/kg crystalloid unless contraindicated as deemed by treating clinician) within the first three hours.
The exclusion criteria are: age < 18 years, pregnant, patients with limitation of care (i.e. do not resuscitate [DNR]), known Glucose-6-Phosphate Dehydrogenase (G6PD) Deficiency, and vasopressor use for > 24 hours prior to study enrollment.
Patients in Arm 1 will randomized to receive usual care + hydrocortisone, thiamine and ascorbic acid. Arm 2 will be randomized to receive usual care alone. Crossover is not allowed. If a patient is randomized into study Arm 2, the treating physician may decide to administer study medications if they feel it is in the best interest of the patient. In this case the patient will continue to be analyzed in their assigned arm on an intention to treat basis. Source of participants will be in-hospital and Emergency Department patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A Prospective Parallel Randomized Controlled clinical Study
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Intervention | Experimental | Drug: STASISArm will be those that are randomized to receive usual care plus hydrocortisone, thiamine and ascorbic acid. |
| Arm 2: Usual care | No intervention | –Arm will be those that are randomized to receive usual care alone. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Septic shock admitted to the ICU within 24 hours as defined by SEPSIS-3
- SEPSIS-3 defines septic shock as sepsis with the following criteria despite adequate fluid resuscitation:
- Age ≥ 18 years
- Non-pregnant
- Ability to consent with medical capacity or legally authorized representative (LAR) consent
Key exclusion criteria (13 listed)
- Age < 18 years
- Pregnant defined by negative serum HCG in all females
- Patients with limitation of care (i.e. DNR)
- Known G6PD deficiency
- Excluding primary admission diagnosis including the following:
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 |
|---|---|---|
| STASISHydrocortisone sodium succinate, 50 mg, every 6 hours, 7 days or until ICU discharge Thiamine, 200 mg, every 12 hours, 4 days or until ICU discharge Ascorbic acid, 1,500 mg, every 6 hours, 4 days or until ICU discharge | Drug | Arm 1: Intervention |
Primary outcome
In-hospital or 28-day mortality rate
Time frame: 28 days or discharge (whichever comes first)
To determine if the addition of hydrocortisone, thiamine and ascorbic acid to standard care versus standard care in septic shock confers an in-hospital and 28-day mortality benefit
10 secondary outcomes
Illness Severity (Change in SOFA Score)
Time frame: 72 hours
Hospital length-of-stay ICU LOS Duration of intubation
Time frame: 1 year or discharge (whichever comes first)
ICU length-of-stay
Time frame: 90 days or discharge (whichever comes first)
Vasopressor duration (days)
Time frame: 28 days or discharge (whichever comes first)
ICU delerium (CAM-ICU score)
Time frame: 28 days or discharge (whichever comes first)
Mechanical ventilation
Time frame: 28 days or discharge (whichever comes first)
Cardiac arrest
Time frame: 28 days or discharge (whichever comes first)
Renal replacement therapy
Time frame: 28 days or discharge (whichever comes first)
C-reactive protein
Time frame: 28 days or discharge (whichever comes first)
Procalcitonin
Time frame: 28 days or discharge (whichever comes first)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2019.
- Individual participant dataSharing planned: No
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Acute Kidney Injury Due to Sepsis
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Veno-arterial Carbon Dioxide Partial Pressure Difference (CO2gap) for Early Resuscitation of Septic Shock
Sepsis - to Reduce Mortality in the Intensive Care Unit, Septic Shock
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Comparison of Cardiac Index Measurement Using Right Ventricular Pressure Curve Analysis and Thermodilution Via a Swan-Ganz IQ™ Catheter.
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RecruitingPhase 3
A Trial of Adjunctive Fludrocortisone (50mcg, 100mcg or Placebo) in Critically Ill Patients With Septic Shock Receiving Hydrocortisone, Evaluating Survival and Functional Recovery and the Influence of Transcriptomic Response
Septic Shock
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.
Andrew C Miller, MD contact
Amir Vahedian-Azimi, PhD principal investigator
Baqiyatallah University of Medical Scienecs
Andrew C Miller, MD principal investigator
East Carolina University
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing STASIS in people with Septic Shock, run by Baqiyatallah Medical Sciences University.
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 13 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: status not confirmed, as of the sponsor's last update on 22 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amir Vahedian-Azimi, PhD (+98 919 6017 138, amirvahedian63@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In-hospital or 28-day mortality rate (time frame: 28 days or discharge (whichever comes first)). 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 22 Oct 2019.