Septic ShockClMLsepsisNCT03700346
Muscle Lactate and Lactate to Pyruvate Ratio Clearance in Septic Shock Patients
A study testing microdialysis in people with Septic Shock, run by Military Hospital of Tunis at 2 sites in Tunisia.
Trial summary
We conducted this study aiming to assess the performance of muscle Lactate and lactate to pyruvate (L/P) ratio clearance in predicting mortality in septic shock patients by using microdialysis. 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?
- microdialysis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 2 sitesTunisia
- Study dates
- 1 Jan 2018to 31 Dec 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients fulfilled the criteria of septic shock
Who cannot join
- pregnancy, uncontrolled hemorrhage, terminal heart failure, significant valvular heart disease, documented or suspected acute coronary syndrome, and limitations on the use of inotropes: left ventricle outflow obstruction, systolic anterior motion of the mitral valve.
- incomplete data
Trial locations and contacts
2 sites in 1 country.
Tunisia2 sites
Military hospital of tunis
Tunis, Mont Fleury, 1008
Military Hopital of Tunis
Tunis, 1008
About this study
Official title: Muscle Lactate and Lactate to Pyruvate Ratio Clearance as Useful Biomarkers for the Prediction of Mortality in Septic Shock Patients
We conducted this study aiming to assess the performance of muscle Lactate and lactate to pyruvate (L/P) ratio clearance in predicting mortality in septic shock patients by using microdialysis.
Read the detailed description
Microcirculatory alterations are frequently observed in patients with sepsis. In vivo microdialysis (MD) is a bedside technique that can monitor tissue metabolic changes. We conducted this study aiming to assess the performance of muscle Lactate and lactate to pyruvate (L/P) ratio clearance in predicting mortality in septic shock patients by using microdialysis.
Interstitial tissue concentrations of lactate, pyruvate, glucose and glycerol were obtained at baseline and every 6 hours for 3 days by using muscle microdialysis. Clearances of muscle lactate, and L/P ratio were defined as the percentage change in muscle lactate level or L/P ratio compared to baseline (H0) values. A positive value of clearance means a decrease in the rate of the parameter under study.
- Conditions
- Septic Shock
- Being tested
- microdialysis
- Medical subject headings
- Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
microdialysisDevice
Interstitial tissue concentrations of lactate, pyruvate, glucose and glycerol were obtained by using muscle microdialysis
| Study group | Role | What they receive |
|---|---|---|
| survivors | Other | survivor at ICU discharge muscle microdialysis Receives: Device: microdialysis |
| Non survivors | Other | death before ICU discharge muscle microdialysis Receives: Device: microdialysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clearances of muscle lactate, and L/P ratio
Clearances of muscle lactate, and L/P ratio were defined as the percentage change in muscle lactate level or L/P ratio compared to baseline (H0) values.
Measured: 3 days
Secondary outcomes (4)
muscle lactate
Interstitial tissue concentration of lactate
Measured: 3 days
muscle pyruvate
Interstitial tissue concentration of pyruvate
Measured: 3 days
muscle glucose
Interstitial tissue concentration of glucose
Measured: 3 days
muscle glycerol
Interstitial tissue concentration of glycerol
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2018
- Study start1 Jan 2018
- Primary completion30 Oct 2018
- Study completion31 Dec 2018
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 N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Military Hospital of Tunis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- zied Hajjej, dr, Principal investigator, Military hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03700346
- Sponsor's protocol ID
- MilitaryHospTunis
- Acronym
- ClMLsepsis
- Status last verified
- Apr 2021
- First submitted
- 30 Sep 2018
- Last updated
- 20 Apr 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 20 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Muscle Lactate and Lactate to Pyruvate Ratio Clearance as Useful Biomarkers for the Prediction of Mortality in Septic Shock Patients
- ClinicalTrials.gov ID
- NCT03700346
- Acronym / sponsor ID
- ClMLsepsis / MilitaryHospTunis
- Conditions
- Septic Shock
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Military Hospital of TunisUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 30 Oct 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 9 Oct 2018 (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.
We conducted this study aiming to assess the performance of muscle Lactate and lactate to pyruvate (L/P) ratio clearance in predicting mortality in septic shock patients by using microdialysis.
Detailed description
Microcirculatory alterations are frequently observed in patients with sepsis. In vivo microdialysis (MD) is a bedside technique that can monitor tissue metabolic changes. We conducted this study aiming to assess the performance of muscle Lactate and lactate to pyruvate (L/P) ratio clearance in predicting mortality in septic shock patients by using microdialysis.
Interstitial tissue concentrations of lactate, pyruvate, glucose and glycerol were obtained at baseline and every 6 hours for 3 days by using muscle microdialysis. Clearances of muscle lactate, and L/P ratio were defined as the percentage change in muscle lactate level or L/P ratio compared to baseline (H0) values. A positive value of clearance means a decrease in the rate of the parameter under study.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| survivors | Other | Device: microdialysissurvivor at ICU discharge muscle microdialysis |
| Non survivors | Other | Device: microdialysisdeath before ICU discharge muscle microdialysis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients fulfilled the criteria of septic shock
Key exclusion criteria (2 listed)
- pregnancy, uncontrolled hemorrhage, terminal heart failure, significant valvular heart disease, documented or suspected acute coronary syndrome, and limitations on the use of inotropes: left ventricle outflow obstruction, systolic anterior motion of the mitral valve.
- incomplete data
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 |
|---|---|---|
| microdialysisInterstitial tissue concentrations of lactate, pyruvate, glucose and glycerol were obtained by using muscle microdialysis | Device | Non survivors, survivors |
Primary outcome
Clearances of muscle lactate, and L/P ratio
Time frame: 3 days
Clearances of muscle lactate, and L/P ratio were defined as the percentage change in muscle lactate level or L/P ratio compared to baseline (H0) values.
4 secondary outcomes
muscle lactate
Time frame: 3 days
muscle pyruvate
Time frame: 3 days
muscle glucose
Time frame: 3 days
muscle glycerol
Time frame: 3 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 20 Apr 2021.
- Individual participant dataSharing planned: No
Related trials for Septic Shock
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Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
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ICU-SUCCEED for Survivors of Acute Respiratory Failure and Their Caregivers
Acute Respiratory Failure, Critical Illness
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Longitudinal Trajectories of Myocardial Work in Patients With Sepsis
Sepsis, Septic Shock Hyperdynamic
RecruitingObservational study
Immunothrombosis With Septic Shock Undergoing Renal Replacement Therapy With the OXIRIS Membrane
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.
zied Hajjej, dr principal investigator
Military hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing microdialysis in people with Septic Shock, run by Military Hospital of Tunis at 2 sites in Tunisia.
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 2 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 20 Apr 2021. 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 Tunisia. 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?
Clearances of muscle lactate, and L/P ratio (time frame: 3 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 20 Apr 2021.