SepsisNCT04160676
Therapy With Hydrocortisone, Ascorbic Acid, Thamine in Patients With Sepsis
A study testing Hydrocortisone, Ascorbic acid, Thiamine and Normal saline in people with Sepsis, run by Tanta University at 1 site in Egypt.
Trial summary
In this study , we suggest that the use of combination of Hydrocortisone, Ascorbic Acid, and Thiamine in patient with sepsis may decrease mortality rate and improve the outcome. This study will be carried out at SICU of Tanta University hospitals on Patients aged from 18 to 65 years old who will be presented with… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Sepsis
- What is being tested?
- Hydrocortisone, Ascorbic acid, Thiamine and Normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2019to 26 Jul 2021
- Phase
- Interventional
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged from 18 to 65 years old who will be presented with sepsis that diagnosed according to the surviving sepsis campaign 2016 and The Surviving Sepsis Campaign Bundle 2018 Update
Who cannot join
- Participant or participants' relatives refusal to continue the study.
- Known or suspected allergy to the studied medications.
- Contraindications to the use of vitamin C as renal stones, Alzheimer's disease and Schizophrenia.
- Pre-existing organ failure or dysfunction not related to the presenting sepsis condition.
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Hydrocortisone-Ascorbic Acid and Thiamine Therapy on the Outcome of Patients With Sepsis: A Prospective Randomized Double-Blinded Controlled Trial
In this study , we suggest that the use of combination of Hydrocortisone, Ascorbic Acid, and Thiamine in patient with sepsis may decrease mortality rate and improve the outcome.
This study will be carried out at SICU of Tanta University hospitals on Patients aged from 18 to 65 years old who will be presented with sepsis that diagnosed according to the surviving sepsis campaign 2016.
Read more
Patients who will meet the previous criteria will be enrolled in the study. The patients will be randomized allocated into two groups by the aid of computer generated software of randomization introduced into sealed closed envelops.
All patients will receive the conventional therapy according to the surviving sepsis campaign 2016 and The Surviving Sepsis Campaign Bundle 2018 Update.
The patients will be allocated randomly into one of the following two groups;-. Group I The patients in this group will be managed only according to the surviving sepsis campaign 2016 and the surviving sepsis campaign bundle 2018 update.
The patients will receive 50 ml normal saline I.V within 30 mins / 6 h, 10 ml normal saline I.V / 6 h, 5 ml normal saline I.V / 12 h.
Group II The patients will receive the conventional therapy of sepsis and combined therapy of hydrocortisone (Solucortif® 100 mg , vial, dried powder Pfizer, Egypt) 50 mg diluted in 5 ml normal saline IV / 6 h, ascorbic acid (VITAMIN C-®, Amp, ROTEXMEDICA, Germany, 500mg/5ml) 1.5 gm diluted in 50 ml normal saline IV within 30 min /6 h , and thiamine (Vitamin B1-injektopas®, Ampoule, Germany, 100 mg / 2 ml) 200 mg diluted in 10 ml normal saline IV /12 h The outcome of the patients, the incidence of organ dysfunction will be assessed.
Read the detailed description
This prospective randomized controlled double-blinded study will be carried out at surgical intensive care units (SICU) in Tanta University Hospitals for a period of 12 months that may be extended after approval from institutional ethical committee.
An informed written consent will be obtained from the patients or patients' relatives.
They will receive an explanation of the purpose of the study and every patient will have a secret code number.
Research results will be only used for scientific purpose. Any unexpected risk/s appearing during the course of research will be clarified to the participants and to the ethical committee on time, however, the patients that will be enrolled in this study have no expected additional risk as we use Hydrocortisone, Ascorbic acid and Thiamin that have minimal side effects.
*Inclusion criteria: Patients aged from 18 to 65 years old who will be presented with sepsis that diagnosed according to the surviving sepsis campaign 2016(21) and The Surviving Sepsis Campaign Bundle 2018 Update.
*Exclusion Criteria:
- Participant or participants' relatives refusal to continue the study.
- Known or suspected allergy to the studied medications.
- Contraindications to the use of vitamin C as renal stones, Alzheimer's disease and Schizophrenia.
- Pre-existing organ failure or dysfunction not related to the presenting sepsis condition.
- Pregnancy.
Patients who will meet the previous criteria will be enrolled in the study. The patients will be randomized allocated into two groups by the aid of computer generated software of randomization introduced into sealed closed envelops.
All patients will receive the conventional therapy according to the surviving sepsis campaign 2016 and The Surviving Sepsis Campaign Bundle 2018 Update.
An intensivist who has no further role in this research work will help in the preparation of the used medications in syringes that will contain medications in group two and normal saline in group one.
(placebo) -I Group The patients in this group will be managed only according to the surviving sepsis campaign 2016 and the surviving sepsis campaign bundle 2018 update.
The patients will receive 50 ml normal saline I.V within 30 mins / 6 h, 10 ml normal saline I.V / 6 h, 5 ml normal saline I.V / 12 h.
Group II The patients will receive the conventional therapy of sepsis and combined therapy of hydrocortisone (Solucortif® 100 mg , vial, dried powder Pfizer, Egypt) 50 mg diluted in 5 ml normal saline IV / 6 h, ascorbic acid (VITAMIN C-®, Amp, ROTEXMEDICA, Germany, 500mg/5ml) 1.5 gm diluted in 50 ml normal saline IV within 30 min /6 h , and thiamine (Vitamin B1-injektopas®, Ampoule, Germany, 100 mg / 2 ml) 200 mg diluted in 10 ml normal saline IV /12 h This combined therapy will be given for 4 days or to the time of discharge if the admission period is less than 4 days.
*Measurements
All data will be collected by intensivists who will be blinded about the study groups. All the patients will be subjected to the following:
- Demographic data (age, gender, weight, cause of sepsis).
- 28th day mortality (If the patient will be discharged, data will be collected by phone calls)
- Sofa score will be recorded daily and compared during the period of the studied drugs administration.
- Incidence of organ dysfunction during the period of ICU stay.
- Mean arterial blood pressure will be recorded every 8 hrs and compared during the period of the studied drugs adminstration.
- Cardiac index will be measured every 8 hrs using Electrical Cardiometry monitor, ICON Cardiotronics, Inc., La Jolla, CA 92307; Osypka Medical GmbH, Berlin,Germany and will be compared between both groups during the period of the studied drugs adminstration.
- Total dose of vasopressor therapy.
- Serum lactate level will be measured daily during the period of the studied drugs administration.
- Serum pocalcitonin level will be measured at time of starting the studied drugs administration and at the end of it.
- Conditions
- Sepsis
- Being tested
- Hydrocortisone, Ascorbic acid, Thiamine, Normal saline
- Keywords
- Hydrocortison, Ascorbic acid, Thiamine
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydrocortisone, Ascorbic acid, ThiamineDrug
Combination of hydrocortisone, ascorbic acid, and thiamine
Normal salineDrug
Normal saline
| Study group | Role | What they receive |
|---|---|---|
| Group I | Active comparator | The patients in this group will be managed only according to the surviving sepsis campaign 2016 and the surviving sepsis campaign bundle 2018 update.
The patients will receive 50 ml normal saline I.V within 30 mins / 6 h, 10 ml normal saline I.V / 6 h, 5 ml normal saline I.V / 12 h. Receives: Drug: Normal saline |
| Group II | Experimental | The patients will receive the conventional therapy of sepsis and combined therapy of hydrocortisone (Solucortif® 100 mg , vial, dried powder Pfizer, Egypt) 50 mg diluted in 5 ml normal saline IV / 6 h, ascorbic acid (VITAMIN C-®, Amp, ROTEXMEDICA, Germany, 500mg/5ml) 1.5 gm diluted in 50 ml normal saline IV within 30 min /6 h , and thiamine (Vitamin B1-injektopas®, Ampoule, Germany, 100 mg / 2 ml) 200 mg diluted in 10 ml normal saline IV /12 h This combined therapy will be given for 4 days or to the time of discharge if the admission period is less than 4 days Receives: Drug: Hydrocortisone, Ascorbic acid, Thiamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
28th day mortality rate.
The incidence of mortality in the first 28 days
Measured: 28 days
Secondary outcomes (2)
Changes in SOFA score
the incidence of organ dysfunction
Measured: 28 days
Changes in serum pocalcitonin level
the plasma level of procalcitonin
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2019
- Study start1 Dec 2019
- Primary completion26 Jul 2021
- Study completion26 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Tanta 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel assignment Prospective study
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Collaborators
- Mostafa Ismail Sharaf, Salah Eldeen Ibrahim Alsherif, Mohamed Mohi El deen Abo El yazeed
- Responsible party
- Principal investigator, Sameh Abdelkhalik Ahmed Ismaiel, Tanta University
- Investigators
- Sameh Ismaiel, M.D, Principal investigator, Lecturer of Anesthesia and Intensive Care, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04160676
- Sponsor's protocol ID
- 33375/09/19
- Status last verified
- Jul 2021
- First submitted
- 9 Nov 2019
- Last updated
- 2 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- 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 2 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Hydrocortisone-Ascorbic Acid and Thiamine Therapy on the Outcome of Patients With Sepsis: A Prospective Randomized Double-Blinded Controlled Trial
- ClinicalTrials.gov ID
- NCT04160676
- Acronym / sponsor ID
- 33375/09/19
- Conditions
- Sepsis
- Keywords
- Hydrocortison, Ascorbic acid, Thiamine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Collaborators
- Mostafa Ismail Sharaf, Salah Eldeen Ibrahim Alsherif, Mohamed Mohi El deen Abo El yazeed
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 26 Jul 2021 (actual)
- Study completion
- 26 Jul 2021 (actual)
- First posted
- 13 Nov 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.
In this study , we suggest that the use of combination of Hydrocortisone, Ascorbic Acid, and Thiamine in patient with sepsis may decrease mortality rate and improve the outcome.
This study will be carried out at SICU of Tanta University hospitals on Patients aged from 18 to 65 years old who will be presented with sepsis that diagnosed according to the surviving sepsis campaign 2016.
Patients who will meet the previous criteria will be enrolled in the study. The patients will be randomized allocated into two groups by the aid of computer generated software of randomization introduced into sealed closed envelops.
All patients will receive the conventional therapy according to the surviving sepsis campaign 2016 and The Surviving Sepsis Campaign Bundle 2018 Update.
The patients will be allocated randomly into one of the following two groups;-. Group I The patients in this group will be managed only according to the surviving sepsis campaign 2016 and the surviving sepsis campaign bundle 2018 update.
The patients will receive 50 ml normal saline I.V within 30 mins / 6 h, 10 ml normal saline I.V / 6 h, 5 ml normal saline I.V / 12 h.
Group II The patients will receive the conventional therapy of sepsis and combined therapy of hydrocortisone (Solucortif® 100 mg , vial, dried powder Pfizer, Egypt) 50 mg diluted in 5 ml normal saline IV / 6 h, ascorbic acid (VITAMIN C-®, Amp, ROTEXMEDICA, Germany, 500mg/5ml) 1.5 gm diluted in 50 ml normal saline IV within 30 min /6 h , and thiamine (Vitamin B1-injektopas®, Ampoule, Germany, 100 mg / 2 ml) 200 mg diluted in 10 ml normal saline IV /12 h The outcome of the patients, the incidence of organ dysfunction will be assessed.
Detailed description
This prospective randomized controlled double-blinded study will be carried out at surgical intensive care units (SICU) in Tanta University Hospitals for a period of 12 months that may be extended after approval from institutional ethical committee.
An informed written consent will be obtained from the patients or patients' relatives.
They will receive an explanation of the purpose of the study and every patient will have a secret code number.
Research results will be only used for scientific purpose. Any unexpected risk/s appearing during the course of research will be clarified to the participants and to the ethical committee on time, however, the patients that will be enrolled in this study have no expected additional risk as we use Hydrocortisone, Ascorbic acid and Thiamin that have minimal side effects.
*Inclusion criteria: Patients aged from 18 to 65 years old who will be presented with sepsis that diagnosed according to the surviving sepsis campaign 2016(21) and The Surviving Sepsis Campaign Bundle 2018 Update.
*Exclusion Criteria:
- Participant or participants' relatives refusal to continue the study.
- Known or suspected allergy to the studied medications.
- Contraindications to the use of vitamin C as renal stones, Alzheimer's disease and Schizophrenia.
- Pre-existing organ failure or dysfunction not related to the presenting sepsis condition.
- Pregnancy.
Patients who will meet the previous criteria will be enrolled in the study. The patients will be randomized allocated into two groups by the aid of computer generated software of randomization introduced into sealed closed envelops.
All patients will receive the conventional therapy according to the surviving sepsis campaign 2016 and The Surviving Sepsis Campaign Bundle 2018 Update.
An intensivist who has no further role in this research work will help in the preparation of the used medications in syringes that will contain medications in group two and normal saline in group one.
(placebo) -I Group The patients in this group will be managed only according to the surviving sepsis campaign 2016 and the surviving sepsis campaign bundle 2018 update.
The patients will receive 50 ml normal saline I.V within 30 mins / 6 h, 10 ml normal saline I.V / 6 h, 5 ml normal saline I.V / 12 h.
Group II The patients will receive the conventional therapy of sepsis and combined therapy of hydrocortisone (Solucortif® 100 mg , vial, dried powder Pfizer, Egypt) 50 mg diluted in 5 ml normal saline IV / 6 h, ascorbic acid (VITAMIN C-®, Amp, ROTEXMEDICA, Germany, 500mg/5ml) 1.5 gm diluted in 50 ml normal saline IV within 30 min /6 h , and thiamine (Vitamin B1-injektopas®, Ampoule, Germany, 100 mg / 2 ml) 200 mg diluted in 10 ml normal saline IV /12 h This combined therapy will be given for 4 days or to the time of discharge if the admission period is less than 4 days.
*Measurements
All data will be collected by intensivists who will be blinded about the study groups. All the patients will be subjected to the following:
- Demographic data (age, gender, weight, cause of sepsis).
- 28th day mortality (If the patient will be discharged, data will be collected by phone calls)
- Sofa score will be recorded daily and compared during the period of the studied drugs administration.
- Incidence of organ dysfunction during the period of ICU stay.
- Mean arterial blood pressure will be recorded every 8 hrs and compared during the period of the studied drugs adminstration.
- Cardiac index will be measured every 8 hrs using Electrical Cardiometry monitor, ICON Cardiotronics, Inc., La Jolla, CA 92307; Osypka Medical GmbH, Berlin,Germany and will be compared between both groups during the period of the studied drugs adminstration.
- Total dose of vasopressor therapy.
- Serum lactate level will be measured daily during the period of the studied drugs administration.
- Serum pocalcitonin level will be measured at time of starting the studied drugs administration and at the end of it.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel assignment Prospective study
| Arm | Type | Receives |
|---|---|---|
| Group I | Active comparator | Drug: Normal salineThe patients in this group will be managed only according to the surviving sepsis campaign 2016 and the surviving sepsis campaign bundle 2018 update. The patients will receive 50 ml normal saline I.V within 30 mins / 6 h, 10 ml normal saline I.V / 6 h, 5 ml normal saline I.V / 12 h. |
| Group II | Experimental | Drug: Hydrocortisone, Ascorbic acid, ThiamineThe patients will receive the conventional therapy of sepsis and combined therapy of hydrocortisone (Solucortif® 100 mg , vial, dried powder Pfizer, Egypt) 50 mg diluted in 5 ml normal saline IV / 6 h, ascorbic acid (VITAMIN C-®, Amp, ROTEXMEDICA, Germany, 500mg/5ml) 1.5 gm diluted in 50 ml normal saline IV within 30 min /6 h , and thiamine (Vitamin B1-injektopas®, Ampoule, Germany, 100 mg / 2 ml) 200 mg diluted in 10 ml normal saline IV /12 h This combined therapy will be given for 4 days or to the time of discharge if the admission period is less than 4 days |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients aged from 18 to 65 years old who will be presented with sepsis that diagnosed according to the surviving sepsis campaign 2016 and The Surviving Sepsis Campaign Bundle 2018 Update
Key exclusion criteria (5 listed)
- Participant or participants' relatives refusal to continue the study.
- Known or suspected allergy to the studied medications.
- Contraindications to the use of vitamin C as renal stones, Alzheimer's disease and Schizophrenia.
- Pre-existing organ failure or dysfunction not related to the presenting sepsis condition.
- Pregnancy.
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 |
|---|---|---|
| Hydrocortisone, Ascorbic acid, ThiamineCombination of hydrocortisone, ascorbic acid, and thiamine | Drug | Group II |
| Normal salineNormal saline | Drug | Group I |
Primary outcome
28th day mortality rate.
Time frame: 28 days
The incidence of mortality in the first 28 days
2 secondary outcomes
Changes in SOFA score
Time frame: 28 days
Changes in serum pocalcitonin level
Time frame: 7 days
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 2 Aug 2021.
- Individual participant dataSharing planned: No
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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.
Sameh Ismaiel, M.D principal investigator
Lecturer of Anesthesia and Intensive Care, Tanta University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hydrocortisone, Ascorbic acid, Thiamine and Normal saline in people with Sepsis, run by Tanta 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 1 inclusion and 5 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 2 Aug 2021. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
28th day mortality rate. (time frame: 28 days). 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 2 Aug 2021.