Septic ShockPhase 1NCT01193777
L-Carnitine Administration in Early Sepsis
A Phase 1 study testing L-Carnitine and Normal Saline in people with Septic Shock, run by Wake Forest University Health Sciences at 2 sites in United States.
Trial summary
Sepsis is a severe and overwhelming response to an infection in the body. Over 750,000 patients in the United States develop sepsis every year. As sepsis becomes progressively more severe, a patient's blood pressure drops to dangerous levels and the body cannot pump oxygen to the rest of the body, which is necessary… 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?
- L-Carnitine and Normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2010to Feb 2012
- 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
- Suspected or confirmed infection
- Any two of four criteria of systemic inflammatory response
- Requirement for vasopressors to treat shock
- Enrollment within 12 hours of vasopressor initiation
- SOFA score of greater than or equal to 5 at the time of enrollment
Who cannot join
- Age <18 years
- Pregnancy or breastfeeding
- Any primary diagnosis other than sepsis
- Established Do Not Resuscitate status or advanced directives restricting aggressive care or treating physician deems aggressive care unsuitable
- Any history of seizures or a known seizure disorder
- Any known inborn error of metabolism
Show all 11Show fewer
- Anticipated requirement for surgery that would interfere with the 12 hour infusion time
- Active participation in another interventional study
- Inability to obtain informed consent
- Cardiopulmonary resuscitation (chest compression or defibrillation) prior to enrollment
- Known systemic allergy to carnitine
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Carolinas Medical Center
Charlotte, North Carolina, 28203
University of Mississippi Medical Center
Jackson, Mississippi, 39216
About this study
Sepsis is a severe and overwhelming response to an infection in the body. Over 750,000 patients in the United States develop sepsis every year. As sepsis becomes progressively more severe, a patient's blood pressure drops to dangerous levels and the body cannot pump oxygen to the rest of the body, which is necessary for normal cell function. This is called septic shock. When someone develops septic shock, it is very common for the smallest blood vessels in the body called the microcirculation to clog, like a highway during rush hour. Even with the best medical care, more than one in three patients with septic shock will die.
The major goal of this study is to test if intravenous replacement of a naturally occurring nutrient that is lost by the body during sepsis called L-carnitine can reduce how sick a patient with sepsis becomes. In our study, some patients will receive L-carnitine and others will receive saline. We will measure markers determining severity of illness in both groups and compare them to see if L-carnitine helps patients get better faster. Based on research already conducted, we believe L-carnitine will improve blood flow in the microcirculation, delivering more oxygen to cells, and help the body get better. To test if this is true, we will directly look at the microcirculation under the tongue with a special magnifying camera that looks at red blood cells, and compare both groups.
- Conditions
- Septic Shock
- Being tested
- L-Carnitine, Normal Saline
- Keywords
- Carnitine, Shock, Sepsis
- Medical subject headings
- Shock, Septic, Shock, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-CarnitineDrug
4 gram bolus followed by 8 gram in 1 L NS infused over 12 hours.
Normal SalineDrug
Bolus followed by 1 L NS infusion over 12 hours.
| Study group | Role | What they receive |
|---|---|---|
| Saline | Placebo comparator | Not described Receives: Drug: Normal Saline |
| L-Carnitine | Experimental | Not described Receives: Drug: L-Carnitine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in organ failure
SOFA score will be measured at 0 and 24 hours
Measured: 24 hours
Secondary outcomes (9)
Microcirculation
Test if carnitine improves blood flow in the sublingual microvasculature during septic shock by performing sidestream dark-field (SDF) video-microscopy of the sublingual microcirculation, prior to and after 12 hours of carnitine infusion.
Measured: 12 hours
ICU and hospital length of stay
Measured: Duration of stay
All-cause mortality
Measured: 28 day
All-cause mortality
Measured: 3 months
All-cause mortality
Measured: 6 months
All-cause mortality
Measured: 12 months
Change in inflammatory markers
Assess change in various inflammatory markers over predefined time points.
Measured: 12 hours
Change in inflammatory markers
Assess change in various inflammatory markers over predefined time points.
Measured: 24 hours
Change in inflammatory markers
Assess change in various inflammatory markers over predefined time points.
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2010 (estimated)
- Study startSep 2010
- Primary completionFeb 2012
- Study completionFeb 2012
Why it stopped: Study stopped to open expanded phase II study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe 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
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association
- Responsible party
- Sponsor
- Investigators
- Alan E Jones, MD, Principal investigator, University of Mississippi and Carolinas Medical Center, Department of Emergency Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01193777
- Sponsor's protocol ID
- 04-10-06A
- Other IDs
- 10POST3560001
- Status last verified
- Mar 2012
- First submitted
- 30 Aug 2010
- Last updated
- 22 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Puskarich MA, Shapiro NI, Massey MJ, Kline JA, Jones AE. Lactate Clearance in Septic Shock Is Not a Surrogate for Improved Microcirculatory Flow. Acad Emerg Med. 2016 Jun;23(6):690-3. doi: 10.1111/acem.12928. Epub 2016 May 11.
PubMed 26825368
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- L-Carnitine Administration in Early Sepsis
- ClinicalTrials.gov ID
- NCT01193777
- Acronym / sponsor ID
- 04-10-06A
- Conditions
- Septic Shock
- Keywords
- Carnitine, Shock, Sepsis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study stopped to open expanded phase II study
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- American Heart Association
- Study start
- Sep 2010
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 2 Sep 2010 (estimated)
- 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.
Sepsis is a severe and overwhelming response to an infection in the body. Over 750,000 patients in the United States develop sepsis every year. As sepsis becomes progressively more severe, a patient's blood pressure drops to dangerous levels and the body cannot pump oxygen to the rest of the body, which is necessary for normal cell function. This is called septic shock. When someone develops septic shock, it is very common for the smallest blood vessels in the body called the microcirculation to clog, like a highway during rush hour. Even with the best medical care, more than one in three patients with septic shock will die.
The major goal of this study is to test if intravenous replacement of a naturally occurring nutrient that is lost by the body during sepsis called L-carnitine can reduce how sick a patient with sepsis becomes. In our study, some patients will receive L-carnitine and others will receive saline. We will measure markers determining severity of illness in both groups and compare them to see if L-carnitine helps patients get better faster. Based on research already conducted, we believe L-carnitine will improve blood flow in the microcirculation, delivering more oxygen to cells, and help the body get better. To test if this is true, we will directly look at the microcirculation under the tongue with a special magnifying camera that looks at red blood cells, and compare both groups.
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 |
|---|---|---|
| Saline | Placebo comparator | Drug: Normal Saline |
| L-Carnitine | Experimental | Drug: L-Carnitine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Suspected or confirmed infection
- Any two of four criteria of systemic inflammatory response
- Requirement for vasopressors to treat shock
- Enrollment within 12 hours of vasopressor initiation
- SOFA score of greater than or equal to 5 at the time of enrollment
Key exclusion criteria (11 listed)
- Age <18 years
- Pregnancy or breastfeeding
- Any primary diagnosis other than sepsis
- Established Do Not Resuscitate status or advanced directives restricting aggressive care or treating physician deems aggressive care unsuitable
- Any history of seizures or a known seizure disorder
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 |
|---|---|---|
| L-Carnitine4 gram bolus followed by 8 gram in 1 L NS infused over 12 hours. | Drug | L-Carnitine |
| Normal SalineBolus followed by 1 L NS infusion over 12 hours. | Drug | Saline |
Primary outcome
Reduction in organ failure
Time frame: 24 hours
SOFA score will be measured at 0 and 24 hours
9 secondary outcomes
Microcirculation
Time frame: 12 hours
ICU and hospital length of stay
Time frame: Duration of stay
All-cause mortality
Time frame: 28 day
All-cause mortality
Time frame: 3 months
All-cause mortality
Time frame: 6 months
All-cause mortality
Time frame: 12 months
Change in inflammatory markers
Time frame: 12 hours
Change in inflammatory markers
Time frame: 24 hours
Change in inflammatory markers
Time frame: 48 hours
Results and safety
The study was stopped early (reason given: Study stopped to open expanded phase II study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2022.
- Derived from this study: PubMed 26825368Puskarich MA, Shapiro NI, Massey MJ, Kline JA, Jones AE. Lactate Clearance in Septic Shock Is Not a Surrogate for Improved Microcirculatory Flow. Acad Emerg Med. 2016 Jun;23(6):690-3. doi: 10.1111/acem.12928. Epub 2016 May 11.
Related trials for Septic Shock
RecruitingObservational study
Immunothrombosis With Septic Shock Undergoing Renal Replacement Therapy With the OXIRIS Membrane
Sepsis
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
Not yet recruitingObservational study
Serum GDF-15 and LGALS3BP as Prognostic Biomarkers in Sepsis
Sepsis, Septic Shock
Not yet recruiting
Hemodynamic Resuscitation Guided by Non-Invasive Mean Systemic Filling Pressure to Prevent Acute Kidney Injury in Septic Shock
Acute Kidney Injury Due to Sepsis
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
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.
Alan E Jones, MD principal investigator
University of Mississippi and Carolinas Medical Center, Department of Emergency Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing L-Carnitine and Normal Saline in people with Septic Shock, run by Wake Forest University Health Sciences at 2 sites 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 5 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 22 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 stopped early (reason given: Study stopped to open expanded phase II study). 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?
Reduction in organ failure (time frame: 24 hours). 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 NCT01193777, which also lists 1 linked publication.
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 Apr 2022.