Septic ShockPhase 1NCT03122678
Thiamine Supplementation in Patients With Septic Shock
A Phase 1 study testing Thiamine in people with Septic Shock and Shock, Septic, run by The Cleveland Clinic at 1 site in United States.
Trial summary
To determine if intravenous thiamine would decrease the time to reversal of shock in patients with septic shock. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Septic Shock, Shock, Septic, Lactic Acidosis
- What is being tested?
- Thiamine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Nov 2016to 14 Mar 2019
- Phase
- Phase 1
- 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
- Age>18
- Sepsis (defined as presence of two or more SIRS criteria with documented or suspected infection)
- SIRS: Systemic Inflammatory Response Syndrome (SIRS) is the occurrence of at least two of the following criteria: temperature >38.0ºC or <36.0ºC, heart rate >90 beats/minute, respiratory rate >20 breaths/minute, white blood cell count >12,000 or <4000.
- Lactate >3mmol/L at the time of consent and randomization
- Hypotension (systolic blood pressure <90mmHg) after a >2L fluid bolus
- Vasopressor dependence (defined as the continuous infusion of norepinephrine, dopamine, phenylephrine, vasopressin or epinephrine.)
Who cannot join
- Known cirrhosis or chronic liver disease
- Current thiamine supplementation
- Clinical indication for thiamine (e.g. Alcohol abuse)
- Comfort measures only designation
- Inability to provide consent
- Other causes for lactate elevation (seizure, use of medications that can cause lactic acidosis such as metformin, linezolid and anti-retrovirals, carbon monoxide, known or suspected bowel or limb ischemia, cardiac arrest prior to enrollment)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Thiamine Supplementation in Patients With Septic Shock: A Randomized, Double Blind, Placebo Controlled Trial
To determine if intravenous thiamine would decrease the time to reversal of shock in patients with septic shock.
Read the detailed description
Patients will be randomized to thiamine supplementation or placebo in a 1:1 ratio. Randomization will be done by the hospital pharmacy department whom will be the only unblinded participants. Patients will receive 200mg thiamine in 50mL of 5% dextrose or matching placebo (50mL 5% dextrose) once daily for 7 days or until discharge from the intensive care unit. The drug will be mixed by the pharmacy. Administration will be done in the patients room in the intensive care unit by the patient's assigned nurse. Blood will be collected on admission to the hospital in order to determine baseline lactate level and study eligibility. The measurement of lactate is standard of care in patients with sepsis. Thiamine level will be collected upon enrollment into the study. The ICU nurse or emergency room nurse taking care of the patient at the time of enrollment will draw the blood sample. Standard procedure for measuring thiamine levels will be maintained including protecting the blood sample from light and keeping it on ice while it is delivered to the lab. Serum lactate will be measured daily for 7 days or until discharge from the intensive care unit. The serial measurement of serum lactate is considered standard of care in patients with sepsis.
- Conditions
- Septic Shock, Shock, Septic, Lactic Acidosis, Thiamine Deficiency
- Being tested
- Thiamine, Placebos
- Medical subject headings
- Shock, Septic, Acidosis, Lactic, Thiamine Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThiamineDrug
Also called Vitamin B1
PlacebosDrug
Also called 50mL 5% dextrose
| Study group | Role | What they receive |
|---|---|---|
| Thiamine Supplementation Group | Experimental | Patients will receive 200mg thiamine in 50mL of 5% dextrose once daily for 7 days or until discharge from the intensive care unit. Receives: Drug: Thiamine |
| Placebo Group | Placebo comparator | Patients will receive placebo (50mL 5% dextrose) once daily for 7 days or until discharge from the intensive care unit. Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Reversal of Shock
Number of hours that the patient required vasopressors
Measured: 7 days
Time to Normalization of Lactic Acidosis
Measured: 7 days
Secondary outcomes (2)
ICU Mortality
Death occurring during the ICU stay
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
ICU Length of Stay
Number of days that the patient remains in the ICU after admission to the ICU
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2017
- Study start5 Nov 2016
- Primary completion14 Mar 2019 (estimated)
- Study completion14 Mar 2019 (estimated)
Why it stopped: No participant enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jinesh Mehta, The Cleveland Clinic
- Investigators
- Jinesh Mehta, MD, Principal investigator, Cleveland Clinic Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03122678
- Sponsor's protocol ID
- FLA 16-058
- Status last verified
- Mar 2019
- First submitted
- 16 Feb 2017
- Last updated
- 15 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thiamine Supplementation in Patients With Septic Shock: A Randomized, Double Blind, Placebo Controlled Trial
- ClinicalTrials.gov ID
- NCT03122678
- Acronym / sponsor ID
- FLA 16-058
- Conditions
- Septic Shock, Shock, Septic, Lactic Acidosis, Thiamine Deficiency
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No participant enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- 5 Nov 2016 (actual)
- Primary completion
- 14 Mar 2019 (estimated)
- Study completion
- 14 Mar 2019 (estimated)
- First posted
- 21 Apr 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.
To determine if intravenous thiamine would decrease the time to reversal of shock in patients with septic shock.
Detailed description
Patients will be randomized to thiamine supplementation or placebo in a 1:1 ratio. Randomization will be done by the hospital pharmacy department whom will be the only unblinded participants. Patients will receive 200mg thiamine in 50mL of 5% dextrose or matching placebo (50mL 5% dextrose) once daily for 7 days or until discharge from the intensive care unit. The drug will be mixed by the pharmacy. Administration will be done in the patients room in the intensive care unit by the patient's assigned nurse. Blood will be collected on admission to the hospital in order to determine baseline lactate level and study eligibility. The measurement of lactate is standard of care in patients with sepsis. Thiamine level will be collected upon enrollment into the study. The ICU nurse or emergency room nurse taking care of the patient at the time of enrollment will draw the blood sample. Standard procedure for measuring thiamine levels will be maintained including protecting the blood sample from light and keeping it on ice while it is delivered to the lab. Serum lactate will be measured daily for 7 days or until discharge from the intensive care unit. The serial measurement of serum lactate is considered standard of care in patients with sepsis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thiamine Supplementation Group | Experimental | Drug: ThiaminePatients will receive 200mg thiamine in 50mL of 5% dextrose once daily for 7 days or until discharge from the intensive care unit. |
| Placebo Group | Placebo comparator | Drug: PlacebosPatients will receive placebo (50mL 5% dextrose) once daily for 7 days or until discharge from the intensive care unit. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age>18
- Sepsis (defined as presence of two or more SIRS criteria with documented or suspected infection)
- SIRS: Systemic Inflammatory Response Syndrome (SIRS) is the occurrence of at least two of the following criteria: temperature >38.0ºC or <36.0ºC, heart rate >90 beats/minute, respiratory rate >20 breaths/minute, white blood cell count >12,000 or <4000.
- Lactate >3mmol/L at the time of consent and randomization
- Hypotension (systolic blood pressure <90mmHg) after a >2L fluid bolus
Key exclusion criteria (6 listed)
- Known cirrhosis or chronic liver disease
- Current thiamine supplementation
- Clinical indication for thiamine (e.g. Alcohol abuse)
- Comfort measures only designation
- Inability to provide consent
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 |
|---|---|---|
| ThiamineAlso: Vitamin B1 | Drug | Thiamine Supplementation Group |
| PlacebosAlso: 50mL 5% dextrose | Drug | Placebo Group |
Primary outcome
Time to Reversal of Shock
Time frame: 7 days
Number of hours that the patient required vasopressors
Time to Normalization of Lactic Acidosis
Time frame: 7 days
2 secondary outcomes
ICU Mortality
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
ICU Length of Stay
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2019.
- Individual participant dataSharing planned: No
Related trials for Septic Shock
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Recruiting
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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Hemodynamic Resuscitation Guided by Non-Invasive Mean Systemic Filling Pressure to Prevent Acute Kidney Injury in Septic Shock
Acute Kidney Injury Due to Sepsis
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Clinical Value of EMR3 in Sepsis Diagnosis, Monitoring, and Prognosis: A Multicenter Prospective Observational Study
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.
Jinesh Mehta, MD principal investigator
Cleveland Clinic Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Thiamine in people with Septic Shock and Shock, Septic, run by The Cleveland Clinic at 1 site in United States.
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 6 inclusion and 6 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: withdrawn, as of the sponsor's last update on 15 Mar 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 United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 withdrawn before enrolling participants, so there are no results.
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?
Time to Reversal of Shock (time frame: 7 days). The study lists 2 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 15 Mar 2019.