Septic ShockPhase 4NCT06152458
Blessing or Curse? Combined Vitamin Therapy in Non Viral Septic Shock.
A Phase 4 study testing Vitamin C in people with Septic Shock, run by University of Pecs at 1 site in Hungary.
Trial summary
Introduction: Septic shock leads to high morbidity and mortality in critically ill patients. Several lower-case scientific studies have supported the synergistic positive effect of vitamin C, thiamine, and hydrocortisone on sepsis-induced organ dysfunction. 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?
- Vitamin C
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteHungary
- Study dates
- 1 Jan 2019to 1 Mar 2020
- 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
- septic shock
- intensive care unit administration
Who cannot join
- under age 18
- above age 80
- moribund patients
- pregnant patients
- active kidney stone
- inability to obtain consent
Show all 10Show fewer
- viral or mixed sepsis
- missed dose of vitamin C/ thiamin or hydrocortisone
- Physician refused
- Vitamin C / Thiamine/ Hydrocortisone for other indications
Trial locations and contacts
1 site in 1 country.
Hungary1 site
Department of Anaesthesia and Intensive Therapy University of Pecs
Pécs, Baranya, 7624
About this study
Introduction: Septic shock leads to high morbidity and mortality in critically ill patients. Several lower-case scientific studies have supported the synergistic positive effect of vitamin C, thiamine, and hydrocortisone on sepsis-induced organ dysfunction.
Aim: Our aim was to investigate the effect of vitamin complex on organ failure, laboratory parameters, respiratory and antibiotic treatment, intensive care time, and mortality in septic shock patients.
Read more
Material and methods: In our retrospective and prospective analysis, we collected parameters from 43 (23 vitamin-treated, 20 control) septic shock patients. Patients treated with vitamin, they received vitamin C (4x1500 mg), thiamine (2x200 mg) for three days (2). In other respects, and for hydrocortisone (200 mg / 24h), both groups of patients received treatment according to the European Sepsis Recommendation. SPSS (V-21) data were used for data collection, Kolmogorov-Smirnov, Wilcoxon, Mann-Whitney U tests were used for statistical analysis.
Ethical license: 7849-PTE 2019.
- Conditions
- Septic Shock
- Being tested
- Vitamin C
- Keywords
- sepsis, vitamin-c, thiamine, septic shock
- Medical subject headings
- Shock, Septic, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin CDrug
Also called Thiamine
Patients in the intervention group (G1) (n=23) received the combined vitamin therapy: IV vitamin C (1.5 g every 6 hours administered as an infusion over 30 to 60 minutes and mixed in a 100- mL solution of normal saline), hydrocortisone (100 mg in bolus-100 mg in perfusor up to 60 min (200mg 24h),), and thiamine (200 mg every 12 hours administered as an infusion over 30 to 60 minutes and mixed in a 100-mL solution of normal saline) for 3 days.
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | Patients in the intervention group (n=23) received the combined vitamin therapy: IV vitamin C (1.5 g every 6 hours administered as an infusion over 30 to 60 minutes and mixed in a 100- mL solution of normal saline), hydrocortisone (100 mg in bolus-100 mg in perfusor up to 60 min (200mg 24h),), and thiamine (200 mg every 12 hours administered as an infusion over 30 to 60 minutes and mixed in a 100-mL solution of normal saline) for 3 days. Receives: Drug: Vitamin C |
| control group | No intervention | As a control group, we selected 20 age- and sex-matched patients with septic shock who did not receive vitamin treatment.They received the standard of care for septic shock. |
What is being measured
The primary outcome is the main question the study is designed to answer.
ventilation
duration of mechanical ventilation (days)
Measured: intensive care unit discharge (up to 90 days)
vasopressors
length of circulatory support (days)
Measured: intensive care unit discharge (up to 90 days)
Length of stay
length of Intensive care unit staying (days)
Measured: intensive care unit discharge (up to 90 days)
main mortality
all-cause mortality (dead/survived) in the intensive care unit
Measured: intensive care unit discharge (up to 90 days)
Secondary outcomes (13)
secondary outcomes
development of inflammatory laboratory parameters:
- se-carbamide (mg/dl)
Measured: up to 5 days after admission to intensive care
secondary outcomes
development of inflammatory laboratory parameters:
- se-creatinine (µmol/L)
Measured: up to 5 days after admission to intensive care
secondary outcomes
development of inflammatory laboratory parameters:
- plateletes (G/L),
Measured: up to 5 days after admission to intensive care
secondary outcomes
development of inflammatory laboratory parameters:
- procalcitonin (ng/ml),
Measured: up to 5 days after admission to intensive care
secondary outcomes
development of inflammatory laboratory parameters:
- white blood cells (G/L)
Measured: up to 5 days after admission to intensive care
secondary outcomes
development of inflammatory laboratory parameters:
- heat shock C-reactive protein (mg/L)
Measured: up to 5 days after admission to intensive care
secondary outcomes
development of inflammatory laboratory parameters:
- se-lactate (mmol/L)
Measured: up to 5 days after admission to intensive care
antibiotics
the length of antibiotic treatment (days)
Measured: intensive care unit discharge (up to 90 days)
PiCCO parameters
changes in invasive hemodynamic parameters-PiCCO ®:
- cardiac index (l/min/m2)
Measured: up to 5 days after admission to intensive care
PiCCO parameters
changes in invasive hemodynamic parameters-PiCCO ®:
- extravascular lung water (ml/kg)
Measured: up to 5 days after admission to intensive care
PiCCO parameters
changes in invasive hemodynamic parameters-PiCCO ®:
- intrathoracic body water (ml/m2)
Measured: up to 5 days after admission to intensive care
PiCCO parameters
changes in invasive hemodynamic parameters-PiCCO ®:
- myocardial contractility (dP/dTmax- (mm hg/s)
Measured: up to 5 days after admission to intensive care
other mortality's
in-hospital, 30- and 60-day mortality (dead/survived)
Measured: up to 60 days after admission to intensive care
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2023
- Study start1 Jan 2019
- Primary completion1 Mar 2020
- Study completion1 Mar 2020
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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pecs
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06152458
- Sponsor's protocol ID
- 7849-PTE 2019
- Status last verified
- Nov 2023
- First submitted
- 1 Sep 2023
- Last updated
- 30 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blessing or Curse? Combined Vitamin Therapy in Non Viral Septic Shock.
- ClinicalTrials.gov ID
- NCT06152458
- Acronym / sponsor ID
- 7849-PTE 2019
- Conditions
- Septic Shock
- Keywords
- sepsis, vitamin-c, thiamine, septic shock
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- University of PecsUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 30 Nov 2023 (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.
Introduction: Septic shock leads to high morbidity and mortality in critically ill patients. Several lower-case scientific studies have supported the synergistic positive effect of vitamin C, thiamine, and hydrocortisone on sepsis-induced organ dysfunction.
Aim: Our aim was to investigate the effect of vitamin complex on organ failure, laboratory parameters, respiratory and antibiotic treatment, intensive care time, and mortality in septic shock patients.
Material and methods: In our retrospective and prospective analysis, we collected parameters from 43 (23 vitamin-treated, 20 control) septic shock patients. Patients treated with vitamin, they received vitamin C (4x1500 mg), thiamine (2x200 mg) for three days (2). In other respects, and for hydrocortisone (200 mg / 24h), both groups of patients received treatment according to the European Sepsis Recommendation. SPSS (V-21) data were used for data collection, Kolmogorov-Smirnov, Wilcoxon, Mann-Whitney U tests were used for statistical analysis.
Ethical license: 7849-PTE 2019.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Drug: Vitamin CPatients in the intervention group (n=23) received the combined vitamin therapy: IV vitamin C (1.5 g every 6 hours administered as an infusion over 30 to 60 minutes and mixed in a 100- mL solution of normal saline), hydrocortisone (100 mg in bolus-100 mg in perfusor up to 60 min (200mg 24h),), and thiamine (200 mg every 12 hours administered as an infusion over 30 to 60 minutes and mixed in a 100-mL solution of normal saline) for 3 days. |
| control group | No intervention | –As a control group, we selected 20 age- and sex-matched patients with septic shock who did not receive vitamin treatment.They received the standard of care for septic shock. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- septic shock
- intensive care unit administration
Key exclusion criteria (10 listed)
- under age 18
- above age 80
- moribund patients
- pregnant patients
- active kidney stone
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: ThiaminePatients in the intervention group (G1) (n=23) received the combined vitamin therapy: IV vitamin C (1.5 g every 6 hours administered as an infusion over 30 to 60 minutes and mixed in a 100- mL solution of normal saline), hydrocortisone (100 mg in bolus-100 mg in perfusor up to 60 min (200mg 24h),), and thiamine (200 mg every 12 hours administered as an infusion over 30 to 60 minutes and mixed in a 100-mL solution of normal saline) for 3 days. | Drug | intervention group |
Primary outcome
ventilation
Time frame: intensive care unit discharge (up to 90 days)
duration of mechanical ventilation (days)
vasopressors
Time frame: intensive care unit discharge (up to 90 days)
length of circulatory support (days)
Length of stay
Time frame: intensive care unit discharge (up to 90 days)
length of Intensive care unit staying (days)
main mortality
Time frame: intensive care unit discharge (up to 90 days)
all-cause mortality (dead/survived) in the intensive care unit
13 secondary outcomes
secondary outcomes
Time frame: up to 5 days after admission to intensive care
secondary outcomes
Time frame: up to 5 days after admission to intensive care
secondary outcomes
Time frame: up to 5 days after admission to intensive care
secondary outcomes
Time frame: up to 5 days after admission to intensive care
secondary outcomes
Time frame: up to 5 days after admission to intensive care
secondary outcomes
Time frame: up to 5 days after admission to intensive care
secondary outcomes
Time frame: up to 5 days after admission to intensive care
antibiotics
Time frame: intensive care unit discharge (up to 90 days)
PiCCO parameters
Time frame: up to 5 days after admission to intensive care
PiCCO parameters
Time frame: up to 5 days after admission to intensive care
PiCCO parameters
Time frame: up to 5 days after admission to intensive care
PiCCO parameters
Time frame: up to 5 days after admission to intensive care
other mortality's
Time frame: up to 60 days after admission to intensive care
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 Nov 2023.
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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 Vitamin C in people with Septic Shock, run by University of Pecs at 1 site in Hungary.
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 10 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 Nov 2023. 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 Hungary. 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. 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?
ventilation (time frame: intensive care unit discharge (up to 90 days)). The study lists 4 primary outcomes in all. 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 Nov 2023.