Septic Shock HyperdynamicPhase 3I-MICRONCT03788837
ILOPROST in Septic Shock With Persistent Microperfusion Defects (I-MICRO)
A Phase 3 study testing ILOPROST and NaCl in people with Septic Shock Hyperdynamic, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Septic shock remains a major cause of death in critically ill patients. Alterations in microcirculation have long been proposed as a key pathophysiological factor of organ dysfunction and death in septic shock patients. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Septic Shock Hyperdynamic
- What is being tested?
- ILOPROST and NaCl
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 1 siteFrance
- Study dates
- 3 Jul 2019to 18 Jan 2024
- Phase
- Phase 3
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients over 18 years of age
- Signed informed consent or inclusion under the emergency provisions of the law (Article L1122 -1-3 of the PHC / modified by Order n°2016-800 of June 16 2016 - art. 2).
- Patients with septic shock defined by the third international definition:
- suspected or proven infection,
- and organ dysfunction defined by an acute change in total SOFA score >or=2
- and persistent hypotension requiring vasopressor treatment to maintain mean arterial pressure > 65 mmHg despite standard of care hemodynamic optimization
Show all 9Show fewer
- and serum lactate level > 2 mmol/L despite standard of care hemodynamic optimization
- and persistence of peripheral hypoperfusion (skin mottling and/or finger skin recoloration time > 3sec, and/or knee skin recoloration time > 4sec) despite standard of care hemodynamic optimization
- Within 6 to 24 hours after norepinephrine onset
Who cannot join
- Refusal to participate in the study
- Pregnancy, breastfeeding
- Hypersensitivity to Ilomedin or to any of the excipients.
- Conditions where the hemorrhagic risk may be increased due to the effects of Ilomedin on platelets (i.e., evolving hemorrhage, trauma, intracranial hemorrhage, active gastric ulcer).
- Platelet count < 10000 /mm3
- unstable angina.
Show all 12Show fewer
- severe cardiac rhythm disorders since Norepinephrine onset
- severe hypoxemia (PaO2/FiO2 <100)
- myocardial infarction in the last 6 months
- lack of Social Insurance
- persons deprived of liberty
- persons of a protective measure
Trial locations and contacts
1 site in 1 country.
France1 site
Departement of Anesthesiology, Critical Care and Burn Unit; Saint-Louis hospital
Paris, 75010
About this study
Official title: " ILOPROST for Treatment of Septic Shock With Persistent Microperfusion Defects ", a Double-blind, Randomized Controlled Trial:The I-MICRO Trial
Septic shock remains a major cause of death in critically ill patients. Alterations in microcirculation have long been proposed as a key pathophysiological factor of organ dysfunction and death in septic shock patients. Persistence of mottling, prolonged skin recoloration time and cyanosis of the extremities are the easily and frequently observed manifestations of these microcirculatory disorders. Ilomedin is a prostaglandin analog with a potent vasodilatory effect together with anti-thrombotic properties (inhibition of platelet aggregation) preferentially at the microcirculatory level. An increase in cardiac output with increased arterial oxygen delivery has been observed in clinical and preclinical studies with no episodes of hypotension. Improvement in mesenteric perfusion has moreover been observed in experimental sepsis using Ilomedin. Our group has furthermore reported that administration of Ilomedin in patients with refractory septic shock (peripheral hypoperfusion) resulted in a rapid and sustained improvement in peripheral perfusion. Altogether, Ilomedin may prevent or improve recovery of organ dysfunction in septic shock patients through recruitment of the microcirculation and, thereby, ultimately improve outcome.
Read the detailed description
In the 32 participating centers: patients with septic shock and persistent peripheral hypoperfusion despite hemodynamic optimization (skin mottling and/or finger skin recoloration time > 3sec, and/or knee skin recoloration time > 4sec), after 6 to 24 hours of norepinephrine onset will be eligible for randomization.
Patients fulfilling the eligibility criteria will be included and randomized by the intensivist in two groups:
*Experimental group: The patient will receive treatment with intravenous Iloprost (blinded) therapy at a dose of 0.5 ng/kg/min with increments of 0.5 ng/kg/min every 30 minutes up to a maximum posology of 1.5ng/kg/min for 48h.
Placebo group: The patient will receive treatment with intravenous NaCl 0.9% (placebo-double blinded) therapy at a dose of 0.5ng/kg/min with increments of 0.5 ng/kg/min every 30 minutes according to body weight with a maximum posology of 1,5 ng/kg/min for 48h.
Primary outcome will be Delta Sequential Organ Failure Assessment (SOFA) score between infusion onset and day 7.
*within the 12 first hours after randomization : blood samples : 15 ml of blood will be collected at the same time as the sample routinely collected, within the 12 first hours after randomization in ICU, when the patients are perfused.
The blood will be drawn and worked as follows:
- 2 x EDTA tubes of 5 ml : After centrifugation each tube will be directly divided into 4 aliquots of 500 µL (8 aliquots per patient)
- 1 x aprotinine tube of 5 ml : After centrifugation, it will be directly divided into 4 aliquots of 500 µL
The aliquots previously will be stored locally, and will be transported to the "Centre de Ressources Biologiques" (CRB) of the Lariboisière Hospital.
- Conditions
- Septic Shock Hyperdynamic
- Being tested
- ILOPROST, NaCl
- Keywords
- Microcirculatory defects, hemodynamic macroparameters, mottling, Septic shock, SOFA score
- Medical subject headings
- Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ILOPROSTDrug
Also called 50 microgrammes /0,5 ml vials
The patient will receive treatment with intravenous ILOPROST therapy at a dose of 0.5ng/kg/min with increments of 0.5 ng/kg/min every 30 minutes up to a maximum posology of 1,5 ng/kg/min for 48h.
NaClDrug
Also called (Saline 0.9%)
The patient will receive treatment with intravenous NaCl 0.9% (placebo-double blinded) with increments of infusion rate every 30 minutes for 48h
| Study group | Role | What they receive |
|---|---|---|
| intravenous ILOPROST | Experimental | a first dose of ILOPROST of 0.5ng/kg/ min with increments every 30 minutes up to a maximum of 1,5 ng/kg/min for 48h Receives: Drug: ILOPROST |
| Intravenous Placebo | Placebo comparator | Treatment with intravenous NaCl 0.9% therapy with incremental infusion rate every 30 minutes for 48h Receives: Drug: NaCl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delta (Sequential Organ Failure Assessment (SOFA)) score between infusion onset and day 7. SOFA score assesses organ failure (respiratory, hemodynamics, liver, coagulation, neurological and kidney) in ICU patients.
SOFA and Delta SOFA calculation will be performed by the Intensivist. Patients deceased before day 7 will be attributed a maximum SOFA score.
SOFA score range from 0 (no organ failure) to a maximum of 24 (worst SOFA score).
Measured: 7 days after randomisation
Secondary outcomes (9)
Mean SOFA score during the first 7 days after randomization
SOFA and Delta SOFA calculation will be performed by the Intensivist.
Measured: 7 days after randomization
Number of survival days outside ICU in the 28 days post randomization
It will be calculated by the number of days between ICU discharge and day 28 in survivors of ICU stay.
Measured: Between ICU discharge and day 28
Number of ventilation-free survival days in the 28 days post randomization
It will be calculated as the number of survival days without mechanical ventilation
Measured: Between randomization and day 28.
Number of renal replacement therapy-free survival days in the 28 days post randomization -
It will be calculated as the number of survival days without renal replacement therapy
Measured: Between randomization and day 28.
Number of vasopressor-free survival days in the 28 days post randomization
It will be calculated as the number of survival days without vasopressor therapy
Measured: Between randomization and day 28.
Molting score at day 1 after randomization.
In order to identifying and quantifying microcirculatory dysfunction in septic shock. A picture of patient's knees will be taken.
Molting score range from 0 to a maximum of 5 :
- - No mottling
- - Coin sized mottling area on the knee.
- - To the superior area of the knee cap.
- - Mottling up to the middle thigh
- - Mottling up to the fold of the groin
- - Severe mottling that extends beyond the the groin.
Measured: At day 1 after randomization
Conservation of plasma for future biological measurements
15 ml of blood will be collected at the same time as the sample routinely collected, within the 12 first hours after randomization, when the patients are perfused.
Measured: within 10 years after the end of the study.
Microcirculation
Monitoring of microcirculation using non-invasive monitoring devices including: photoplethysmography,cutaneous Doppler coupled with iontophoresis, near-infrared spectroscopy, videomicroscopy, tissular PCO2, urethral photoplethysmography, perfusion index using phtoplethysmography
Measured: At the baseline, and between day 2 and day 7
mortality
Measured: At day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2018
- Study start3 Jul 2019
- Primary completion5 Jan 2024
- Study completion18 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Septic Shock HyperdynamicStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- François DEPRET, MD, Principal investigator, APHP-Hôpital saint LouisMatthieu LEGRAND, MD,PhD, Study director, APHP-Hôpital saint Louis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03788837
- Sponsor's protocol ID
- P170924J
- Acronym
- I-MICRO
- Status last verified
- Jul 2024
- First submitted
- 20 Nov 2018
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
De Backer D, Donadello K. Assessment of microperfusion in sepsis. Minerva Anestesiol. 2015 May;81(5):533-40. Epub 2014 Jun 19.
PubMed 24941897Ait-Oufella H, Lemoinne S, Boelle PY, Galbois A, Baudel JL, Lemant J, Joffre J, Margetis D, Guidet B, Maury E, Offenstadt G. Mottling score predicts survival in septic shock. Intensive Care Med. 2011 May;37(5):801-7. doi: 10.1007/s00134-011-2163-y. Epub 2011 Mar 4.
PubMed 21373821Muller B, Schmidtke M. Microvascular effects of iloprost in the hamster cheek pouch. Adv Prostaglandin Thromboxane Leukot Res. 1987;17A:455-8.
PubMed 2444080Johannes T, Ince C, Klingel K, Unertl KE, Mik EG. Iloprost preserves renal oxygenation and restores kidney function in endotoxemia-related acute renal failure in the rat. Crit Care Med. 2009 Apr;37(4):1423-32. doi: 10.1097/CCM.0b013e31819b5f4e.
PubMed 19318827Hoeper MM, Gall H, Seyfarth HJ, Halank M, Ghofrani HA, Winkler J, Golpon H, Olsson KM, Nickel N, Opitz C, Ewert R. Long-term outcome with intravenous iloprost in pulmonary arterial hypertension. Eur Respir J. 2009 Jul;34(1):132-7. doi: 10.1183/09031936.00130408. Epub 2009 Feb 27.
PubMed 19251782Lara B, Enberg L, Ortega M, Leon P, Kripper C, Aguilera P, Kattan E, Castro R, Bakker J, Hernandez G. Capillary refill time during fluid resuscitation in patients with sepsis-related hyperlactatemia at the emergency department is related to mortality. PLoS One. 2017 Nov 27;12(11):e0188548. doi: 10.1371/journal.pone.0188548. eCollection 2017.
PubMed 29176794Depret F, Sitbon A, Soussi S, De Tymowski C, Blet A, Fratani A, Legrand M. Intravenous iloprost to recruit the microcirculation in septic shock patients? Intensive Care Med. 2018 Jan;44(1):121-122. doi: 10.1007/s00134-017-4935-5. Epub 2017 Sep 18. No abstract available.
PubMed 28921126Legrand M, Jullien E, Kimmoun A, Geri G, Ait-Oufella H, Abrard S, Gaugain S, Bounes F, Guerci P, Pottecher J, Jamme M, Poncelin de Raucourt Y, Barraud D, Constantin JM, Juguet W, Lasocki S, Sonneville R, Audibert J, Plantefeve G, Ellrodt O, Fedou AL, Leone M, Lefebvre L, Auvet A, Chen D, Vicaut E, Depret F; I-MICRO Trial Investigators. Iloprost for the Treatment of Severe Septic Shock with Persistent Hypoperfusion: A Double-Blind, Randomized Controlled Trial. Am J Respir Crit Care Med. 2025 Jul;211(7):1211-1219. doi: 10.1164/rccm.202410-1924OC.
PubMed 40387381Legrand M, Oufella HA, De Backer D, Duranteau J, Leone M, Levy B, Rossignol P, Vicaut E, Depret F; I-MICRO trial investigators. The I-MICRO trial, Ilomedin for treatment of septic shock with persistent microperfusion defects: a double-blind, randomized controlled trial-study protocol for a randomized controlled trial. Trials. 2020 Jul 1;21(1):601. doi: 10.1186/s13063-020-04549-y.
PubMed 32611377
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- " ILOPROST for Treatment of Septic Shock With Persistent Microperfusion Defects ", a Double-blind, Randomized Controlled Trial:The I-MICRO Trial
- ClinicalTrials.gov ID
- NCT03788837
- Acronym / sponsor ID
- I-MICRO / P170924J
- Conditions
- Septic Shock Hyperdynamic
- Keywords
- Microcirculatory defects, hemodynamic macroparameters, mottling, Septic shock, SOFA score
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 3 Jul 2019 (actual)
- Primary completion
- 5 Jan 2024 (actual)
- Study completion
- 18 Jan 2024 (actual)
- First posted
- 28 Dec 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.
Septic shock remains a major cause of death in critically ill patients. Alterations in microcirculation have long been proposed as a key pathophysiological factor of organ dysfunction and death in septic shock patients. Persistence of mottling, prolonged skin recoloration time and cyanosis of the extremities are the easily and frequently observed manifestations of these microcirculatory disorders. Ilomedin is a prostaglandin analog with a potent vasodilatory effect together with anti-thrombotic properties (inhibition of platelet aggregation) preferentially at the microcirculatory level. An increase in cardiac output with increased arterial oxygen delivery has been observed in clinical and preclinical studies with no episodes of hypotension. Improvement in mesenteric perfusion has moreover been observed in experimental sepsis using Ilomedin. Our group has furthermore reported that administration of Ilomedin in patients with refractory septic shock (peripheral hypoperfusion) resulted in a rapid and sustained improvement in peripheral perfusion. Altogether, Ilomedin may prevent or improve recovery of organ dysfunction in septic shock patients through recruitment of the microcirculation and, thereby, ultimately improve outcome.
Detailed description
In the 32 participating centers: patients with septic shock and persistent peripheral hypoperfusion despite hemodynamic optimization (skin mottling and/or finger skin recoloration time > 3sec, and/or knee skin recoloration time > 4sec), after 6 to 24 hours of norepinephrine onset will be eligible for randomization.
Patients fulfilling the eligibility criteria will be included and randomized by the intensivist in two groups:
*Experimental group: The patient will receive treatment with intravenous Iloprost (blinded) therapy at a dose of 0.5 ng/kg/min with increments of 0.5 ng/kg/min every 30 minutes up to a maximum posology of 1.5ng/kg/min for 48h.
Placebo group: The patient will receive treatment with intravenous NaCl 0.9% (placebo-double blinded) therapy at a dose of 0.5ng/kg/min with increments of 0.5 ng/kg/min every 30 minutes according to body weight with a maximum posology of 1,5 ng/kg/min for 48h.
Primary outcome will be Delta Sequential Organ Failure Assessment (SOFA) score between infusion onset and day 7.
*within the 12 first hours after randomization : blood samples : 15 ml of blood will be collected at the same time as the sample routinely collected, within the 12 first hours after randomization in ICU, when the patients are perfused.
The blood will be drawn and worked as follows:
- 2 x EDTA tubes of 5 ml : After centrifugation each tube will be directly divided into 4 aliquots of 500 µL (8 aliquots per patient)
- 1 x aprotinine tube of 5 ml : After centrifugation, it will be directly divided into 4 aliquots of 500 µL
The aliquots previously will be stored locally, and will be transported to the "Centre de Ressources Biologiques" (CRB) of the Lariboisière Hospital.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intravenous ILOPROST | Experimental | Drug: ILOPROSTa first dose of ILOPROST of 0.5ng/kg/ min with increments every 30 minutes up to a maximum of 1,5 ng/kg/min for 48h |
| Intravenous Placebo | Placebo comparator | Drug: NaClTreatment with intravenous NaCl 0.9% therapy with incremental infusion rate every 30 minutes for 48h |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients over 18 years of age
- Signed informed consent or inclusion under the emergency provisions of the law (Article L1122 -1-3 of the PHC / modified by Order n°2016-800 of June 16 2016 - art. 2).
- Patients with septic shock defined by the third international definition:
Key exclusion criteria (12 listed)
- Refusal to participate in the study
- Pregnancy, breastfeeding
- Hypersensitivity to Ilomedin or to any of the excipients.
- Conditions where the hemorrhagic risk may be increased due to the effects of Ilomedin on platelets (i.e., evolving hemorrhage, trauma, intracranial hemorrhage, active gastric ulcer).
- Platelet count < 10000 /mm3
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 |
|---|---|---|
| ILOPROSTAlso: 50 microgrammes /0,5 ml vialsThe patient will receive treatment with intravenous ILOPROST therapy at a dose of 0.5ng/kg/min with increments of 0.5 ng/kg/min every 30 minutes up to a maximum posology of 1,5 ng/kg/min for 48h. | Drug | intravenous ILOPROST |
| NaClAlso: (Saline 0.9%)The patient will receive treatment with intravenous NaCl 0.9% (placebo-double blinded) with increments of infusion rate every 30 minutes for 48h | Drug | Intravenous Placebo |
Primary outcome
Delta (Sequential Organ Failure Assessment (SOFA)) score between infusion onset and day 7. SOFA score assesses organ failure (respiratory, hemodynamics, liver, coagulation, neurological and kidney) in ICU patients.
Time frame: 7 days after randomisation
SOFA and Delta SOFA calculation will be performed by the Intensivist. Patients deceased before day 7 will be attributed a maximum SOFA score. SOFA score range from 0 (no organ failure) to a maximum of 24 (worst SOFA score).
9 secondary outcomes
Mean SOFA score during the first 7 days after randomization
Time frame: 7 days after randomization
Number of survival days outside ICU in the 28 days post randomization
Time frame: Between ICU discharge and day 28
Number of ventilation-free survival days in the 28 days post randomization
Time frame: Between randomization and day 28.
Number of renal replacement therapy-free survival days in the 28 days post randomization -
Time frame: Between randomization and day 28.
Number of vasopressor-free survival days in the 28 days post randomization
Time frame: Between randomization and day 28.
Molting score at day 1 after randomization.
Time frame: At day 1 after randomization
Conservation of plasma for future biological measurements
Time frame: within 10 years after the end of the study.
Microcirculation
Time frame: At the baseline, and between day 2 and day 7
mortality
Time frame: At day 28
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 3 Jul 2024.
- Background: PubMed 24941897De Backer D, Donadello K. Assessment of microperfusion in sepsis. Minerva Anestesiol. 2015 May;81(5):533-40. Epub 2014 Jun 19.
- Background: PubMed 21373821Ait-Oufella H, Lemoinne S, Boelle PY, Galbois A, Baudel JL, Lemant J, Joffre J, Margetis D, Guidet B, Maury E, Offenstadt G. Mottling score predicts survival in septic shock. Intensive Care Med. 2011 May;37(5):801-7. doi: 10.1007/s00134-011-2163-y. Epub 2011 Mar 4.
- Background: PubMed 2444080Muller B, Schmidtke M. Microvascular effects of iloprost in the hamster cheek pouch. Adv Prostaglandin Thromboxane Leukot Res. 1987;17A:455-8.
- Background: PubMed 19318827Johannes T, Ince C, Klingel K, Unertl KE, Mik EG. Iloprost preserves renal oxygenation and restores kidney function in endotoxemia-related acute renal failure in the rat. Crit Care Med. 2009 Apr;37(4):1423-32. doi: 10.1097/CCM.0b013e31819b5f4e.
- Background: PubMed 19251782Hoeper MM, Gall H, Seyfarth HJ, Halank M, Ghofrani HA, Winkler J, Golpon H, Olsson KM, Nickel N, Opitz C, Ewert R. Long-term outcome with intravenous iloprost in pulmonary arterial hypertension. Eur Respir J. 2009 Jul;34(1):132-7. doi: 10.1183/09031936.00130408. Epub 2009 Feb 27.
- Background: PubMed 29176794Lara B, Enberg L, Ortega M, Leon P, Kripper C, Aguilera P, Kattan E, Castro R, Bakker J, Hernandez G. Capillary refill time during fluid resuscitation in patients with sepsis-related hyperlactatemia at the emergency department is related to mortality. PLoS One. 2017 Nov 27;12(11):e0188548. doi: 10.1371/journal.pone.0188548. eCollection 2017.
- Background: PubMed 28921126Depret F, Sitbon A, Soussi S, De Tymowski C, Blet A, Fratani A, Legrand M. Intravenous iloprost to recruit the microcirculation in septic shock patients? Intensive Care Med. 2018 Jan;44(1):121-122. doi: 10.1007/s00134-017-4935-5. Epub 2017 Sep 18. No abstract available.
- Derived from this study: PubMed 40387381Legrand M, Jullien E, Kimmoun A, Geri G, Ait-Oufella H, Abrard S, Gaugain S, Bounes F, Guerci P, Pottecher J, Jamme M, Poncelin de Raucourt Y, Barraud D, Constantin JM, Juguet W, Lasocki S, Sonneville R, Audibert J, Plantefeve G, Ellrodt O, Fedou AL, Leone M, Lefebvre L, Auvet A, Chen D, Vicaut E, Depret F; I-MICRO Trial Investigators. Iloprost for the Treatment of Severe Septic Shock with Persistent Hypoperfusion: A Double-Blind, Randomized Controlled Trial. Am J Respir Crit Care Med. 2025 Jul;211(7):1211-1219. doi: 10.1164/rccm.202410-1924OC.
- Derived from this study: PubMed 32611377Legrand M, Oufella HA, De Backer D, Duranteau J, Leone M, Levy B, Rossignol P, Vicaut E, Depret F; I-MICRO trial investigators. The I-MICRO trial, Ilomedin for treatment of septic shock with persistent microperfusion defects: a double-blind, randomized controlled trial-study protocol for a randomized controlled trial. Trials. 2020 Jul 1;21(1):601. doi: 10.1186/s13063-020-04549-y.
- Individual participant dataSharing planned: No
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.
François DEPRET, MD principal investigator
APHP-Hôpital saint Louis
Matthieu LEGRAND, MD,PhD study director
APHP-Hôpital saint Louis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ILOPROST and NaCl in people with Septic Shock Hyperdynamic, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 9 inclusion and 12 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 3 Jul 2024. 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 France. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 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?
Delta (Sequential Organ Failure Assessment (SOFA)) score between infusion onset and day 7. SOFA score assesses organ failure (respiratory, hemodynamics, liver, coagulation, neurological and kidney) in ICU patients. (time frame: 7 days after randomisation). 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 NCT03788837, which also lists 9 linked publications.
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 3 Jul 2024.