Septic ShockNCT02963454
Effects of Levosimendan on Cellular Metabolic Alterations in Patients With Septic Shock
A study testing Microdialysis Probe (Muscle microdialysis), Dobutamine and Levosimendan in people with Septic Shock, run by Military Hospital of Tunis at 1 site in Tunisia.
Trial summary
To investigate changes in the concentration of glucose, lactate, pyruvate and glycerol in the extracellular fluid of the skeletal muscle following levosimendan administration in patients with septic shock. Read more about this study
- Who is it for?
- Ages 16 to 90 years
- Conditions the study is for
- Septic Shock
- What is being tested?
- Microdialysis Probe (Muscle microdialysis), Dobutamine and Levosimendan
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTunisia
- Study dates
- Jan 2011to Feb 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 16 to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients who fulfilled the criteria of septic shock that required norepinephrine (NE) to maintain a mean arterial pressure (MAP) of at least 65 mm Hg despite appropriate volume resuscitation (pulmonary arterial occlusion pressure [PAOP] = 12 to 18 mm Hg and central venous pressure [CVP] = 8 to 12 mm Hg)
Who cannot join
- pregnancy, uncontrolled hemorrhage, terminal heart failure, significant valvular heart disease, documented or suspected acute coronary syndrome, and a limitation on the use of inotropes: left ventricle outflow obstruction, systolic anterior motion of the mitral valve.
Trial locations and contacts
1 site in 1 country.
Tunisia1 site, 1 recruiting
- Recruiting
Military Hopital of Tunis
Tunis, 1008
zied hajjej, 20358907 ext. 00216, hajjej_zied@hotmail.com
mustapha ferjani, 98329256 ext. 00216, mustapha.ferjani@planet.tn
About this study
Official title: Effects of Levosimendan on Cellular Metabolic Alterations in Patients With Septic Shock: A Randomised Controlled Study
To investigate changes in the concentration of glucose, lactate, pyruvate and glycerol in the extracellular fluid of the skeletal muscle following levosimendan administration in patients with septic shock.
Read the detailed description
The study was designed as a prospective, double-blind, controlled, clinical trial and performed in a multidisciplinary intensive care unit. After achieving normovolemia and a mean arterial pressure of at least 65 mmHg, 20 septic shock patients were randomized to receive either levosimendan 0.2 μg/kg/min, or dobutamine 5 μg/kg/min. Interstitial tissue concentrations of lactate, pyruvate, glucose and glycerol were obtained by using muscle microdialysis. All measurements, including data from right heart catheterization were obtained at baseline and every 6 hours for the following 72 hours after randomization.
- Conditions
- Septic Shock
- Being tested
- Microdialysis Probe (Muscle microdialysis), Dobutamine, Levosimendan
- Medical subject headings
- Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microdialysis Probe (Muscle microdialysis)Device
Interstitial tissue concentrations of lactate, pyruvate, glucose and glycerol were determined at baseline and then every six hours for the following 72 hours after randomization.
During the study period, conventional treatment was continued as per usual practice. Fluid challenges were performed, and repeated as necessary, to maintain central venous pressure (CVP) ≥8 and pulmonary arterial occlusion pressure (PAOP) ≥12 mmHg. Norepinephrine was titrated to maintain mean arterial pressure (MAP) ≥65 mmHg. Packed red blood cells were transfused when Hemoglobin (Hb) concentrations decreased below 7 g/dL, or if the patient exhibited clinical signs of inadequate systemic oxygen supply.
DobutamineDrug
Also called DOBUTREX
Dobutamine (5 μg/kg/min) will be used as indicated
LevosimendanDrug
Also called SIMDAX
Levosimendan (0.2 μg/kg/min) will be used as indicated
| Study group | Role | What they receive |
|---|---|---|
| levosimendan 0.2 μg/kg/min | Experimental | Treatment with levosimendan 0.2 μg/kg/min 24h (without bolus).
Muscle microdialysis was performed using a microdialysis probe inserted into the quadriceps femoris muscle. Receives: Device: Microdialysis Probe (Muscle microdialysis); Drug: Levosimendan |
| dobutamine 5 μg/kg/min | Active comparator | Treatment with dobutamine 5 μg/kg/min. Dobutamine were administered during all the 72 hours study period.
Muscle microdialysis was performed using a microdialysis probe inserted into the quadriceps femoris muscle. Receives: Device: Microdialysis Probe (Muscle microdialysis); Drug: Dobutamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in the concentration of glucose(mmol/l) in the extracellular fluid of the skeletal muscle
Measured: At baseline and then every six hours for the following 72 hours after randomization.
changes in the concentration of lactate(mmol/l) in the extracellular fluid of the skeletal muscle
Measured: At baseline and then every six hours for the following 72 hours after randomization.
changes in the concentration of pyruvate (µmol/l) in the extracellular fluid of the skeletal muscle
Measured: At baseline and then every six hours for the following 72 hours after randomization.
changes in the concentration of glycerol (µmol/l) in the extracellular fluid of the skeletal muscle
Measured: At baseline and then every six hours for the following 72 hours after randomization.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2016 (estimated)
- Study startJan 2011
- Primary completionFeb 2018 (estimated)
- Study completionFeb 2018 (estimated)
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.
- 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Military Hospital of Tunis
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hajjej Zied, Military Hospital of Tunis
- Investigators
- mustapha ferhjani, Study director, Department of C ritical C are Medicine and Anesthesiology, Military Hospital of Tunis, Tunisia, Tunis, Tunisia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02963454
- Sponsor's protocol ID
- LEVO02
- Status last verified
- Feb 2018
- First submitted
- 4 Nov 2016
- Last updated
- 12 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: via emails
Publications
Hajjej Z, Meddeb B, Sellami W, Labbene I, Morelli A, Ferjani M. Effects of Levosimendan on Cellular Metabolic Alterations in Patients With Septic Shock: A Randomized Controlled Pilot Study. Shock. 2017 Sep;48(3):307-312. doi: 10.1097/SHK.0000000000000851.
PubMed 28234790
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Levosimendan on Cellular Metabolic Alterations in Patients With Septic Shock: A Randomised Controlled Study
- ClinicalTrials.gov ID
- NCT02963454
- Acronym / sponsor ID
- LEVO02
- Conditions
- Septic Shock
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Military Hospital of TunisUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Feb 2018 (estimated)
- Study completion
- Feb 2018 (estimated)
- First posted
- 15 Nov 2016 (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.
To investigate changes in the concentration of glucose, lactate, pyruvate and glycerol in the extracellular fluid of the skeletal muscle following levosimendan administration in patients with septic shock.
Detailed description
The study was designed as a prospective, double-blind, controlled, clinical trial and performed in a multidisciplinary intensive care unit. After achieving normovolemia and a mean arterial pressure of at least 65 mmHg, 20 septic shock patients were randomized to receive either levosimendan 0.2 μg/kg/min, or dobutamine 5 μg/kg/min. Interstitial tissue concentrations of lactate, pyruvate, glucose and glycerol were obtained by using muscle microdialysis. All measurements, including data from right heart catheterization were obtained at baseline and every 6 hours for the following 72 hours after randomization.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| levosimendan 0.2 μg/kg/min | Experimental | Device: Microdialysis Probe (Muscle microdialysis), Drug: LevosimendanTreatment with levosimendan 0.2 μg/kg/min 24h (without bolus). Muscle microdialysis was performed using a microdialysis probe inserted into the quadriceps femoris muscle. |
| dobutamine 5 μg/kg/min | Active comparator | Device: Microdialysis Probe (Muscle microdialysis), Drug: DobutamineTreatment with dobutamine 5 μg/kg/min. Dobutamine were administered during all the 72 hours study period. Muscle microdialysis was performed using a microdialysis probe inserted into the quadriceps femoris muscle. |
Who may qualify
- Ages
- 16 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- patients who fulfilled the criteria of septic shock that required norepinephrine (NE) to maintain a mean arterial pressure (MAP) of at least 65 mm Hg despite appropriate volume resuscitation (pulmonary arterial occlusion pressure [PAOP] = 12 to 18 mm Hg and central venous pressure [CVP] = 8 to 12 mm Hg)
Key exclusion criteria (1 listed)
- pregnancy, uncontrolled hemorrhage, terminal heart failure, significant valvular heart disease, documented or suspected acute coronary syndrome, and a limitation on the use of inotropes: left ventricle outflow obstruction, systolic anterior motion of the mitral valve.
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 |
|---|---|---|
| Microdialysis Probe (Muscle microdialysis)Interstitial tissue concentrations of lactate, pyruvate, glucose and glycerol were determined at baseline and then every six hours for the following 72 hours after randomization. During the study period, conventional treatment was continued as per usual practice. Fluid challenges were performed, and repeated as necessary, to maintain central venous pressure (CVP) ≥8 and pulmonary arterial occlusion pressure (PAOP) ≥12 mmHg. Norepinephrine was titrated to maintain mean arterial pressure (MAP) ≥65 mmHg. Packed red blood cells were transfused when Hemoglobin (Hb) concentrations decreased below 7 g/dL, or if the patient exhibited clinical signs of inadequate systemic oxygen supply. | Device | dobutamine 5 μg/kg/min, levosimendan 0.2 μg/kg/min |
| DobutamineAlso: DOBUTREXDobutamine (5 μg/kg/min) will be used as indicated | Drug | dobutamine 5 μg/kg/min |
| LevosimendanAlso: SIMDAXLevosimendan (0.2 μg/kg/min) will be used as indicated | Drug | levosimendan 0.2 μg/kg/min |
Primary outcome
changes in the concentration of glucose(mmol/l) in the extracellular fluid of the skeletal muscle
Time frame: At baseline and then every six hours for the following 72 hours after randomization.
changes in the concentration of lactate(mmol/l) in the extracellular fluid of the skeletal muscle
Time frame: At baseline and then every six hours for the following 72 hours after randomization.
changes in the concentration of pyruvate (µmol/l) in the extracellular fluid of the skeletal muscle
Time frame: At baseline and then every six hours for the following 72 hours after randomization.
changes in the concentration of glycerol (µmol/l) in the extracellular fluid of the skeletal muscle
Time frame: At baseline and then every six hours for the following 72 hours after randomization.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2018.
- Derived from this study: PubMed 28234790Hajjej Z, Meddeb B, Sellami W, Labbene I, Morelli A, Ferjani M. Effects of Levosimendan on Cellular Metabolic Alterations in Patients With Septic Shock: A Randomized Controlled Pilot Study. Shock. 2017 Sep;48(3):307-312. doi: 10.1097/SHK.0000000000000851.
- Individual participant dataSharing planned: No. via emails
Related trials for Septic Shock
Not yet recruiting
Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
Active, not recruitingPhase 4
Thymosin Alpha 1 and IgM Levels in Sepsis
Sepsis, Septic Shock
Not yet recruiting
ICU-SUCCEED for Survivors of Acute Respiratory Failure and Their Caregivers
Acute Respiratory Failure, Critical Illness
Not yet recruitingObservational study
Longitudinal Trajectories of Myocardial Work in Patients With Sepsis
Sepsis, Septic Shock Hyperdynamic
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
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.
mustapha ferhjani study director
Department of C ritical C are Medicine and Anesthesiology, Military Hospital of Tunis, Tunisia, Tunis, Tunisia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Microdialysis Probe (Muscle microdialysis), Dobutamine and Levosimendan in people with Septic Shock, run by Military Hospital of Tunis at 1 site 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 1 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: status not confirmed, as of the sponsor's last update on 12 Feb 2018. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact zied hajjej (20358907, hajjej_zied@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes in the concentration of glucose(mmol/l) in the extracellular fluid of the skeletal muscle (time frame: At baseline and then every six hours for the following 72 hours after randomization.). 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?
On the ClinicalTrials.gov record for NCT02963454, 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 12 Feb 2018; AzTrials last refreshed its copy on 8 Nov 2026.