SepsisPhase 4NCT03335124
The Effect of Vitamin C, Thiamine and Hydrocortisone on Clinical Course and Outcome in Patients With Severe Sepsis and Septic Shock
A Phase 4 study testing Vitamin C, Hydrocortisone and Thiamine in people with Sepsis and Septic Shock, run by University Medical Centre Ljubljana at 1 site in Slovenia.
Trial summary
The global burden of sepsis is substantial with an estimated 15 to 19 million cases per year; the vast majority of these cases occur in low income countries. New therapeutic approaches to sepsis are desperately required; considering the global burden of sepsis these interventions should be effective, cheap, safe and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Septic Shock, Critical Illness
- What is being tested?
- Vitamin C, Hydrocortisone and Thiamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5 participants
- Where
- 1 siteSlovenia
- Study dates
- 26 Sep 2017to 1 Dec 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of severe sepsis or septic shock within 12 hours of admission in our Intensive Care Unit (ICU).
- Informed consent.
Who cannot join
- Age < 18 years
- Pregnancy
- Do Not Resuscitate (DNR/DNI) with limitations of care
- Patients with fatal underlying disease who are unlikely to survive to hospital discharge (e.g.: disseminated malignant disease)
- Patients primarily admitted for acute coronary syndromes, acute cerebrovascular incidents or active gastrointestinal (GI) bleeds
- Patients that need immediate surgical treatment
Show all 11Show fewer
- Patients with HIV and a cell count of cluster of differentiation 4 (CD4) cells < 50 mm2,
- Patients with known glucose-6 phosphate dehydrogenase (G-6PD) deficiency.
- Patients with severe sepsis/septic shock transferred from another hospital
- Patients with features of sepsis/septic shock > 24 hours
- Patients who require treatment with corticosteroids for an indication other than sepsis (chronic corticosteroid use, known Addison's Disease, Ulcerative colitis, Crohn's disease...)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double Blind, Placebo-Controlled Study to Investigate the Effects of Vitamin C, Hydrocortisone and Thiamine on the Outcome of Patients With Severe Sepsis and Septic Shock
The global burden of sepsis is substantial with an estimated 15 to 19 million cases per year; the vast majority of these cases occur in low income countries. New therapeutic approaches to sepsis are desperately required; considering the global burden of sepsis these interventions should be effective, cheap, safe and readily available. The aim is to study the synergistic effect of vitamin C, hydrocortisone and thiamine on survival in patients with severe sepsis and septic shock.
Read the detailed description
AIM OF THE STUDY:
The goal is to determine the effects on clinical course and outcome of patients with severe sepsis and septic shock treated with vitamin C, hydrocortisone and thiamine.
BACKGROUND:
This study will be conducted in the intensive care unit of Department of Gastroenterology, University Medical Center (UMC) Ljubljana. All of the patients with severe sepsis and septic shock admitted to the Intensive Care Unit (ICU) in the past 12 hours will be screened for possible inclusion in the study. The diagnosis of severe sepsis and septic shock will be based on the 1992 American College of Chest Physicians/Society of Critical Care Medicine Consensus Conference definitions.
PLAN OF THE STUDY:
After determining the eligibility for inclusion in our study, the investigators will acquire the written consent from the patient or relatives. The investigators (doctor on call) will randomize the patient either in the treatment or placebo group. The randomization will be done before-hand with the online tool Research Randomizer. After acquiring the randomized numbers, they will be placed in sealed envelopes. These envelopes will be available to the on-call doctor. The envelopes will then be sent to our outpatient clinic, where the studied substances will be mixed by a nurse, that will have no contact with the patients or the ICU staff. The substances will be marked with Vitamin C, Thiamine and Hydrocortisone, regardless if normal saline or the actual substances are inside the vials. Only this nurse will have the data regarding the contents of the vials.
Based on literature the investigators expect that survival and clinical course in sepsis and septic shock is correlated with fluid resuscitation and vasopressor use. Because of this, all of the included patients will be monitored with invasive hemodynamic monitoring (All of the patients will be monitored with the Edwards EV 1000 monitors).
All of the patients will be treated the same as per internationally recognized guidelines for treatment of septic shock. While the use of corticosteroids in severe sepsis is off-label, the patients will be informed of possible side-effects. This fact will also be written in the consent.
Neither the patients or the relatives will receive no financial compensation for study inclusion. During the hospitalization, the patients will receive three different substances in dosages, that are non toxic. During the study, there will be intermittent statistical analysis, and if increased mortality or severe side effects will be found then the study will be terminated. The confidentiality of personal data will be protected accordingly with the rules and laws of patient's privacy. The identity of patients will not be disclosed. The data acquired during the study will be available to the study participant. The anticipated costs will be covered by the Department of Gastroenterology, UMC Ljubljana. No financial compensation will be given to researchers.
During the study the following data will be acquired from the patients:
- Age,
- Sex,
- Body weight,
- Admitting diagnosis and source of infection,
- Isolated pathogens,
- Comorbidities,
- The need for mechanical ventilation,
- The use of vasopressors (all doses will be converted to Norepinephrine equivalents),
- The duration of vasoactive therapy,
- Daily urine output,
- Fluid balance after 24 and 72 hours,
- The presence of acute kidney failure
- Duration of ICU stay and hospital stay,
- Survival in ICU, hospital, after 28 and 60 days
- Routine blood test for the first 4 days, a. creatinine b. White Blood Cells (WBC) c. Platelets d. Bilirubin e. Partial Pressure of Oxygen in Arterial Blood/Fraction of Inspired Oxygen (PaO2/FiO2) ratio e. procalcitonin (PCT) and procalcitonin clearance f. lactate g. blood samples will be stored for possible additional analysis
The patients' admission Acute Physiology and Chronic Health Evaluation (APACHE) II and APACHE IV scores will be recorded. The APACHE IV score allows calculation of the predicted hospital mortality and predicted ICU length of stay (LOS). The daily Sepsis-related Organ Failure Assessment (SOFA) score will be recorded for the first 4 treatment days.
Data analysis:
Summary statistics will be used to describe the clinical data and presented as mean ± standard deviation (SD), median with interquartile range (IQR) or percentages as appropriate. Chi squared analysis with Fisher's exact test (when appropriate) and Student's t test (Mann Whitney U test for non-normal distributions) were used to compare data between the active treatment group and the placebo group with statistical significance declared for probability values of 0.05 or less.
Data Safety \& storage:
The main risk to subjects is the accidental release of Protected Health Information (PHI). Careful record management methods will be in place to ensure this type of privacy breach does not occur. The data set will be kept in a password-protected file and stored separately from the subject identification (ID) key in the locked office of the principal investigator. Only the research team will have access to this information, and will not disclose this information to any other person or entity. Three years after the completion of the study, all collected data will be destroyed by permanently deleting electronic copies.
EXPECTED RESULTS:
The investigators expect a faster recovery, shorter hospitalization, shorter use of vasoactive drugs and better survival in treatment group versus (vs.) control group.
- Conditions
- Sepsis, Septic Shock, Critical Illness, Fluid Overload
- Being tested
- Vitamin C, Hydrocortisone, Thiamine, 0.9% Sodium Chloride Injection
- Keywords
- Sepsis, Vitamin C, Hydrocortisone, Thiamine, Critical Illness, Fluid Responsiveness, Hemodynamics
- Medical subject headings
- Sepsis, Shock, Septic, Critical Illness, Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin CDrug
Also called Ascorbic Acid
Vitamin C: Vitamin C will be applied as per instructions described in arm/group descriptions.
HydrocortisoneDrug
Also called Corticosteroids
Hydrocortisone: Hydrocortisone will be applied as per instructions described in arm/group descriptions.
ThiamineDrug
Also called B1 Vitamin
Intravenous thiamine will be applied as per instructions described in arm/group descriptions.
0.9% Sodium Chloride InjectionDrug
Also called Normal Saline
0.9 % Sodium Chloride will be applied as placebo as per instructions described in arm/group descriptions.
| Study group | Role | What they receive |
|---|---|---|
| Active substances | Experimental | Vitamin C: Vitamin C will be mixed as 1500 mg vitamin C in 50ml container, which will then be infused over 30 minutes to 1 hour. The bag will be labeled by the pharmacy as Vitamin C. The dosing schedule is 1500mg every 6 hours for 4 days or until discharge from the ICU.
Hydrocortisone: Hydrocortisone will be mixed as 50 mg of Hydrocortisone in 50 ml of 0.9 % Sodium Chloride. Patients will be treated with hydrocortisone 50mg IV q 6 hourly for 4 days or until ICU discharge.
Thiamine: Intravenous thiamine will be given in a dose of 200mg q 12 hourly for 4 days or until ICU discharge. Receives: Drug: Vitamin C; Drug: Hydrocortisone; Drug: Thiamine |
| Control | Placebo comparator | Vitamin C placebo will consist of an identical container of 50cc normal saline (0.9% Sodium Chloride Injection) (but with no vitamin C) and will be labelled vitamin C. Placebo will be infused over 30-60 minutes as per the infusion instructions of the active vitamin. Hydrocortisone placebo will be provided in an identical 50 ml bag of 0.9% Sodium Chloride Injection. Placebo patients will receive a matching vial of 0.9% Sodium Chloride Injection. Receives: Drug: 0.9% Sodium Chloride Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital mortality
We will compare mortality between the treatment and placebo groups during the hospitalization
Measured: From date of randomization till time of discharge, assessed up to 12 months
Secondary outcomes (7)
60 day mortality
We will compare mortality between the treatment and placebo groups after 60 days after inclusion in the study
Measured: 60 days from inclusion in the study
28 day mortality
We will compare mortality between the treatment and placebo groups after 28 days after inclusion in the study
Measured: 28 days from inclusion in the study
Time to vasopressor independence
Defined as the time from starting the active treatment/placebo to discontinuation of all pressors
Measured: Defined as the time from starting the active treatment/placebo to discontinuation of all pressors, till discharged from ICU, assessed in the first month
PCT clearance
Clearance of calculated procalcitonin using the following formula: initial PCT minus PCT at 96 hours, divided by the initial PCT multiplied by 100.
Measured: The first 4 days in Intensive Care Unit
Delta SOFA score
Delta Systemic Organ Failure Assesment score, defined as the initial SOFA score minus the day 4 SOFA score. The Sequential Organ Failure Assessment (SOFA) is a morbidity severity score and mortality estimation tool developed from a large sample of ICU patients throughout the world. The higher the value, the higher the mortality. The maximum score is 24, the lowest 0.
Measured: The first 4 days in Intensive Care Unit
ICU length of stay (LOS) and ICU free days.
ICU free days is calculated as the number of days alive and out of the ICU to day 28
Measured: ICU free days is calculated as the number of days alive and out of the ICU to day 28
Hospital Length of Stay
The length of stay in the hospital
Measured: Hospital Length of Stay through the study completion, assessed up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2017
- Study start26 Sep 2017
- Primary completion1 Dec 2018
- Study completion1 Dec 2018
Why it stopped: Due to insufficient recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by University Medical Centre LjubljanaThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sebastian Stefanovic, MD, University Medical Centre Ljubljana
- Investigators
- Sebastian Stefanovic, MD, Principal investigator, University Medical Center Ljubljana, Department of Gastroenterology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03335124
- Sponsor's protocol ID
- CSEPSIS
- Status last verified
- Feb 2019
- First submitted
- 25 Oct 2017
- Last updated
- 19 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected IPD
Publications
Marik PE, Khangoora V, Rivera R, Hooper MH, Catravas J. Hydrocortisone, Vitamin C, and Thiamine for the Treatment of Severe Sepsis and Septic Shock: A Retrospective Before-After Study. Chest. 2017 Jun;151(6):1229-1238. doi: 10.1016/j.chest.2016.11.036. Epub 2016 Dec 6.
PubMed 27940189Donnino MW, Andersen LW, Chase M, Berg KM, Tidswell M, Giberson T, Wolfe R, Moskowitz A, Smithline H, Ngo L, Cocchi MN; Center for Resuscitation Science Research Group. Randomized, Double-Blind, Placebo-Controlled Trial of Thiamine as a Metabolic Resuscitator in Septic Shock: A Pilot Study. Crit Care Med. 2016 Feb;44(2):360-7. doi: 10.1097/CCM.0000000000001572.
PubMed 26771781Marik PE, Pastores SM, Annane D, Meduri GU, Sprung CL, Arlt W, Keh D, Briegel J, Beishuizen A, Dimopoulou I, Tsagarakis S, Singer M, Chrousos GP, Zaloga G, Bokhari F, Vogeser M; American College of Critical Care Medicine. Recommendations for the diagnosis and management of corticosteroid insufficiency in critically ill adult patients: consensus statements from an international task force by the American College of Critical Care Medicine. Crit Care Med. 2008 Jun;36(6):1937-49. doi: 10.1097/CCM.0b013e31817603ba.
PubMed 18496365Artenstein AW, Higgins TL, Opal SM. Sepsis and scientific revolutions. Crit Care Med. 2013 Dec;41(12):2770-2. doi: 10.1097/CCM.0b013e31829eb98f.
PubMed 23989175
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind, Placebo-Controlled Study to Investigate the Effects of Vitamin C, Hydrocortisone and Thiamine on the Outcome of Patients With Severe Sepsis and Septic Shock
- ClinicalTrials.gov ID
- NCT03335124
- Acronym / sponsor ID
- CSEPSIS
- Conditions
- Sepsis, Septic Shock, Critical Illness, Fluid Overload
- Keywords
- Sepsis, Vitamin C, Hydrocortisone, Thiamine, Critical Illness, Fluid Responsiveness, Hemodynamics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to insufficient recruitment
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Study start
- 26 Sep 2017 (actual)
- Primary completion
- 1 Dec 2018 (actual)
- Study completion
- 1 Dec 2018 (actual)
- First posted
- 7 Nov 2017 (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 global burden of sepsis is substantial with an estimated 15 to 19 million cases per year; the vast majority of these cases occur in low income countries. New therapeutic approaches to sepsis are desperately required; considering the global burden of sepsis these interventions should be effective, cheap, safe and readily available. The aim is to study the synergistic effect of vitamin C, hydrocortisone and thiamine on survival in patients with severe sepsis and septic shock.
Detailed description
AIM OF THE STUDY:
The goal is to determine the effects on clinical course and outcome of patients with severe sepsis and septic shock treated with vitamin C, hydrocortisone and thiamine.
BACKGROUND:
This study will be conducted in the intensive care unit of Department of Gastroenterology, University Medical Center (UMC) Ljubljana. All of the patients with severe sepsis and septic shock admitted to the Intensive Care Unit (ICU) in the past 12 hours will be screened for possible inclusion in the study. The diagnosis of severe sepsis and septic shock will be based on the 1992 American College of Chest Physicians/Society of Critical Care Medicine Consensus Conference definitions.
PLAN OF THE STUDY:
After determining the eligibility for inclusion in our study, the investigators will acquire the written consent from the patient or relatives. The investigators (doctor on call) will randomize the patient either in the treatment or placebo group. The randomization will be done before-hand with the online tool Research Randomizer. After acquiring the randomized numbers, they will be placed in sealed envelopes. These envelopes will be available to the on-call doctor. The envelopes will then be sent to our outpatient clinic, where the studied substances will be mixed by a nurse, that will have no contact with the patients or the ICU staff. The substances will be marked with Vitamin C, Thiamine and Hydrocortisone, regardless if normal saline or the actual substances are inside the vials. Only this nurse will have the data regarding the contents of the vials.
Based on literature the investigators expect that survival and clinical course in sepsis and septic shock is correlated with fluid resuscitation and vasopressor use. Because of this, all of the included patients will be monitored with invasive hemodynamic monitoring (All of the patients will be monitored with the Edwards EV 1000 monitors).
All of the patients will be treated the same as per internationally recognized guidelines for treatment of septic shock. While the use of corticosteroids in severe sepsis is off-label, the patients will be informed of possible side-effects. This fact will also be written in the consent.
Neither the patients or the relatives will receive no financial compensation for study inclusion. During the hospitalization, the patients will receive three different substances in dosages, that are non toxic. During the study, there will be intermittent statistical analysis, and if increased mortality or severe side effects will be found then the study will be terminated. The confidentiality of personal data will be protected accordingly with the rules and laws of patient's privacy. The identity of patients will not be disclosed. The data acquired during the study will be available to the study participant. The anticipated costs will be covered by the Department of Gastroenterology, UMC Ljubljana. No financial compensation will be given to researchers.
During the study the following data will be acquired from the patients:
- Age,
- Sex,
- Body weight,
- Admitting diagnosis and source of infection,
- Isolated pathogens,
- Comorbidities,
- The need for mechanical ventilation,
- The use of vasopressors (all doses will be converted to Norepinephrine equivalents),
- The duration of vasoactive therapy,
- Daily urine output,
- Fluid balance after 24 and 72 hours,
- The presence of acute kidney failure
- Duration of ICU stay and hospital stay,
- Survival in ICU, hospital, after 28 and 60 days
- Routine blood test for the first 4 days, a. creatinine b. White Blood Cells (WBC) c. Platelets d. Bilirubin e. Partial Pressure of Oxygen in Arterial Blood/Fraction of Inspired Oxygen (PaO2/FiO2) ratio e. procalcitonin (PCT) and procalcitonin clearance f. lactate g. blood samples will be stored for possible additional analysis
The patients' admission Acute Physiology and Chronic Health Evaluation (APACHE) II and APACHE IV scores will be recorded. The APACHE IV score allows calculation of the predicted hospital mortality and predicted ICU length of stay (LOS). The daily Sepsis-related Organ Failure Assessment (SOFA) score will be recorded for the first 4 treatment days.
Data analysis:
Summary statistics will be used to describe the clinical data and presented as mean ± standard deviation (SD), median with interquartile range (IQR) or percentages as appropriate. Chi squared analysis with Fisher's exact test (when appropriate) and Student's t test (Mann Whitney U test for non-normal distributions) were used to compare data between the active treatment group and the placebo group with statistical significance declared for probability values of 0.05 or less.
Data Safety \& storage:
The main risk to subjects is the accidental release of Protected Health Information (PHI). Careful record management methods will be in place to ensure this type of privacy breach does not occur. The data set will be kept in a password-protected file and stored separately from the subject identification (ID) key in the locked office of the principal investigator. Only the research team will have access to this information, and will not disclose this information to any other person or entity. Three years after the completion of the study, all collected data will be destroyed by permanently deleting electronic copies.
EXPECTED RESULTS:
The investigators expect a faster recovery, shorter hospitalization, shorter use of vasoactive drugs and better survival in treatment group versus (vs.) control group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active substances | Experimental | Drug: Vitamin C, Drug: Hydrocortisone, Drug: ThiamineVitamin C: Vitamin C will be mixed as 1500 mg vitamin C in 50ml container, which will then be infused over 30 minutes to 1 hour. The bag will be labeled by the pharmacy as Vitamin C. The dosing schedule is 1500mg every 6 hours for 4 days or until discharge from the ICU. Hydrocortisone: Hydrocortisone will be mixed as 50 mg of Hydrocortisone in 50 ml of 0.9 % Sodium Chloride. Patients will be treated with hydrocortisone 50mg IV q 6 hourly for 4 days or until ICU discharge. Thiamine: Intravenous thiamine will be given in a dose of 200mg q 12 hourly for 4 days or until ICU discharge. |
| Control | Placebo comparator | Drug: 0.9% Sodium Chloride InjectionVitamin C placebo will consist of an identical container of 50cc normal saline (0.9% Sodium Chloride Injection) (but with no vitamin C) and will be labelled vitamin C. Placebo will be infused over 30-60 minutes as per the infusion instructions of the active vitamin. Hydrocortisone placebo will be provided in an identical 50 ml bag of 0.9% Sodium Chloride Injection. Placebo patients will receive a matching vial of 0.9% Sodium Chloride Injection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of severe sepsis or septic shock within 12 hours of admission in our Intensive Care Unit (ICU).
- Informed consent.
Key exclusion criteria (11 listed)
- Age < 18 years
- Pregnancy
- Do Not Resuscitate (DNR/DNI) with limitations of care
- Patients with fatal underlying disease who are unlikely to survive to hospital discharge (e.g.: disseminated malignant disease)
- Patients primarily admitted for acute coronary syndromes, acute cerebrovascular incidents or active gastrointestinal (GI) bleeds
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 |
|---|---|---|
| Vitamin CAlso: Ascorbic AcidVitamin C: Vitamin C will be applied as per instructions described in arm/group descriptions. | Drug | Active substances |
| HydrocortisoneAlso: CorticosteroidsHydrocortisone: Hydrocortisone will be applied as per instructions described in arm/group descriptions. | Drug | Active substances |
| ThiamineAlso: B1 VitaminIntravenous thiamine will be applied as per instructions described in arm/group descriptions. | Drug | Active substances |
| 0.9% Sodium Chloride InjectionAlso: Normal Saline0.9 % Sodium Chloride will be applied as placebo as per instructions described in arm/group descriptions. | Drug | Control |
Primary outcome
Hospital mortality
Time frame: From date of randomization till time of discharge, assessed up to 12 months
We will compare mortality between the treatment and placebo groups during the hospitalization
7 secondary outcomes
60 day mortality
Time frame: 60 days from inclusion in the study
28 day mortality
Time frame: 28 days from inclusion in the study
Time to vasopressor independence
Time frame: Defined as the time from starting the active treatment/placebo to discontinuation of all pressors, till discharged from ICU, assessed in the first month
PCT clearance
Time frame: The first 4 days in Intensive Care Unit
Delta SOFA score
Time frame: The first 4 days in Intensive Care Unit
ICU length of stay (LOS) and ICU free days.
Time frame: ICU free days is calculated as the number of days alive and out of the ICU to day 28
Hospital Length of Stay
Time frame: Hospital Length of Stay through the study completion, assessed up to 12 months
Results and safety
The study was stopped early (reason given: Due to insufficient recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2019.
- Background: PubMed 27940189Marik PE, Khangoora V, Rivera R, Hooper MH, Catravas J. Hydrocortisone, Vitamin C, and Thiamine for the Treatment of Severe Sepsis and Septic Shock: A Retrospective Before-After Study. Chest. 2017 Jun;151(6):1229-1238. doi: 10.1016/j.chest.2016.11.036. Epub 2016 Dec 6.
- Background: PubMed 26771781Donnino MW, Andersen LW, Chase M, Berg KM, Tidswell M, Giberson T, Wolfe R, Moskowitz A, Smithline H, Ngo L, Cocchi MN; Center for Resuscitation Science Research Group. Randomized, Double-Blind, Placebo-Controlled Trial of Thiamine as a Metabolic Resuscitator in Septic Shock: A Pilot Study. Crit Care Med. 2016 Feb;44(2):360-7. doi: 10.1097/CCM.0000000000001572.
- Background: PubMed 18496365Marik PE, Pastores SM, Annane D, Meduri GU, Sprung CL, Arlt W, Keh D, Briegel J, Beishuizen A, Dimopoulou I, Tsagarakis S, Singer M, Chrousos GP, Zaloga G, Bokhari F, Vogeser M; American College of Critical Care Medicine. Recommendations for the diagnosis and management of corticosteroid insufficiency in critically ill adult patients: consensus statements from an international task force by the American College of Critical Care Medicine. Crit Care Med. 2008 Jun;36(6):1937-49. doi: 10.1097/CCM.0b013e31817603ba.
- Background: PubMed 23989175Artenstein AW, Higgins TL, Opal SM. Sepsis and scientific revolutions. Crit Care Med. 2013 Dec;41(12):2770-2. doi: 10.1097/CCM.0b013e31829eb98f.
- Individual participant dataSharing planned: Yes. All collected IPD
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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.
Sebastian Stefanovic, MD principal investigator
University Medical Center Ljubljana, Department of Gastroenterology
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 Vitamin C, Hydrocortisone and Thiamine in people with Sepsis and Septic Shock, run by University Medical Centre Ljubljana at 1 site in Slovenia.
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 2 inclusion and 11 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: stopped early, as of the sponsor's last update on 19 Feb 2019. 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 Slovenia. 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 was stopped early (reason given: Due to insufficient recruitment). Results are not available in the source record.
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?
Hospital mortality (time frame: From date of randomization till time of discharge, assessed up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03335124, which also lists 4 linked publications.
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 19 Feb 2019.