Septic ShockIPSISNCT07039227
Evaluation of the Prognostic Value of Immature Platelet Fraction
An observational study of Septic Shock, run by University Hospital, Rouen at 1 site in France.
Trial summary
Sepsis is a public health issue responsible for six million deaths worldwide each year. It is one of the leading causes of admission and morbidity and mortality in critical care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Septic Shock
- How many people
- 196 participants
- Where
- 1 siteFrance
- Study dates
- 28 Apr 2023to 1 Dec 2025
- How long will I take part?
- 28 Years
- Phase
- Observational
- 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
Study population: Patients admitted to critical care for sepsis or septic shock
Who may be able to join
- Any adult patient admitted to critical care for sepsis defined by a SOFA score > or = 2 or an increase of at least 2 points if there was organ dysfunction pre-existing to the infection.
- For the inflammatory control group, we will include adult patients who have required extracorporeal circulation for more than 1 hour for cardiac surgery.
- Patients who have read and understood the information letter and do not object to participating in the study
- Patients affiliated with a social security scheme
Who cannot join
- Patient refusal
- Pregnant, parturient, or breastfeeding woman
- Person deprived of liberty by an administrative or judicial decision or person placed under judicial protection/guardianship or curatorship
- Person who does not understand or speak French
- Moribund
- Febrile aplasia
Show all 9Show fewer
- Hematological diseases
- Decompensated cirrhosis
- Ongoing chemotherapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Prognostic Value of Immature Platelet Fraction in Septic Patients Admitted to Critical Care
Sepsis is a public health issue responsible for six million deaths worldwide each year. It is one of the leading causes of admission and morbidity and mortality in critical care. Its most severe form, septic shock, is responsible for a picture of multiple organ failure syndrome with a high mortality rate estimated at 38%. It appears important to identify routinely available and low-cost biomarkers to identify patients at risk of adverse outcomes.
Read the detailed description
In the pathophysiology of host defense against infection, coagulation plays a major role. In the most severe forms of sepsis, there is an activation of coagulation, particularly platelets, which can cause an alteration of microcirculation and contribute to organ failure. This mechanism is called thromboinflammation. The appearance of thrombocytopenia in sepsis is a risk factor for severity and intrahospital mortality. Immature (or reticulated) platelets are young platelets that have just been released by the bone marrow. They are more prothrombotic and hyperactive than more mature platelets. They are a good marker of thrombopoiesis and platelet renewal, and can be easily obtained routinely on a complete blood count. Several studies show that the immature platelet count and/or fraction (IPF) could be a useful tool for predicting the development of sepsis and its severity. It appears interesting to study these IPFs in patients with sepsis to identify them and implement more aggressive therapies to prevent adverse outcomes in these patients. To distinguish between sepsis and inflammation and validate this marker, it will be compared to an inflammatory group using patients who underwent cardiopulmonary bypass as part of cardiac surgery.
The main objective of this study is to investigate the potential impact of the immature platelet fraction on the prognosis at day 28 of patients admitted to critical care for sepsis or septic shock.
- Conditions
- Septic Shock
- Keywords
- coagulation, highlighting of biomarkers
- Medical subject headings
- Shock, Septic, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Sepsis Group | Patient admitted for sepsis in critical care | |
| Inflammatory control group | Patient admitted for an anesthesia consultation for cardiac surgery under extracorporeal circulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the impact of the immature platelet fraction of patients admitted to intensive care for sepsis or septic shock on their prognosis at day 28.
Measurement of the fraction of immature platelets at admission in patients with sepsis or septic shock defined by the composite criterion calculated on the occurrence of death at 28 days of follow-up
Measured: Days 28
Evaluation of the impact of the immature platelet fraction of patients admitted to intensive care for sepsis or septic shock on their prognosis at day 28.
Measurement of the fraction of immature platelets at admission in patients with sepsis or septic shock defined by the composite criterion calculated on the occurrence of organ failure: implementation of extrarenal purification and/or renal failure KDIGO 3 and/or moderate to severe acute respiratory distress syndrome and/or intense vasoplegic septic shock with noradrenaline > 0.25 µg/kg/min or vasopressin > 0.02 IU/h and/or myocardial dysfunction with venous oxygen saturation < 60 or a cardiac index < 2.2 l/min/m2 and/or occurrence of disseminated intravascular coagulation (DIC)
Measured: Days 28
Secondary outcomes (6)
To assess the impact of the immature platelet fraction on the occurrence of thrombocytopenia
Occurrence of thrombocytopenia defined by a fall > or = to 30% of its baseline value or a platelet count < less than 150,000 G/L
Measured: days 28
Assess the impact of the immature platelet fraction on the progression to disseminated vascular coagulopathy
Demonstration of disseminated intravascular coagulation (DIC)
Measured: Days 28
Evaluation of the impact of the immature platelet fraction on the occurrence of thromboembolic events
Evidence of the onset of thromboembolic venous disease
Measured: Days 28
Assessment of the occurrence of multiple organ failure syndrome
Evidence of a multi-organ failure syndrome defined by the occurrence of at least 2 organ failures
Measured: Days 28
Assessment of the occurrence of recourse to mechanical ventilation
Highlighting the use of mechanical ventilation
Measured: Days 28
Assessment of mortality in intensive care, in hospital and on D28
Determination of Mortality in intensive care, in hospital and on D28
Measured: At enrollment visit, day 1, days 3, days 7 and Days 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2025
- Study start28 Apr 2023
- Primary completion1 Jun 2025
- Study completion1 Dec 2025
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 University Hospital, RouenThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 196 participants (actual)
- Target duration
- 28 Years
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Perrine PL LEPRETRE, Doctor, Study director, University Rouen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07039227
- Sponsor's protocol ID
- 2022/314/OB
- Other IDs
- N° IDRCB : 2022-A02612-41
- Acronym
- IPSIS
- Status last verified
- May 2025
- First submitted
- 18 Jun 2025
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data provided will be the property of the sponsor and will be used solely for its own research activities.
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Prognostic Value of Immature Platelet Fraction in Septic Patients Admitted to Critical Care
- ClinicalTrials.gov ID
- NCT07039227
- Acronym / sponsor ID
- IPSIS / 2022/314/OB
- Conditions
- Septic Shock
- Keywords
- coagulation, highlighting of biomarkers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 196 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 28 Apr 2023 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 26 Jun 2025 (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.
Sepsis is a public health issue responsible for six million deaths worldwide each year. It is one of the leading causes of admission and morbidity and mortality in critical care. Its most severe form, septic shock, is responsible for a picture of multiple organ failure syndrome with a high mortality rate estimated at 38%. It appears important to identify routinely available and low-cost biomarkers to identify patients at risk of adverse outcomes.
Detailed description
In the pathophysiology of host defense against infection, coagulation plays a major role. In the most severe forms of sepsis, there is an activation of coagulation, particularly platelets, which can cause an alteration of microcirculation and contribute to organ failure. This mechanism is called thromboinflammation. The appearance of thrombocytopenia in sepsis is a risk factor for severity and intrahospital mortality. Immature (or reticulated) platelets are young platelets that have just been released by the bone marrow. They are more prothrombotic and hyperactive than more mature platelets. They are a good marker of thrombopoiesis and platelet renewal, and can be easily obtained routinely on a complete blood count. Several studies show that the immature platelet count and/or fraction (IPF) could be a useful tool for predicting the development of sepsis and its severity. It appears interesting to study these IPFs in patients with sepsis to identify them and implement more aggressive therapies to prevent adverse outcomes in these patients. To distinguish between sepsis and inflammation and validate this marker, it will be compared to an inflammatory group using patients who underwent cardiopulmonary bypass as part of cardiac surgery.
The main objective of this study is to investigate the potential impact of the immature platelet fraction on the prognosis at day 28 of patients admitted to critical care for sepsis or septic shock.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 28 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sepsis Group | – | –Patient admitted for sepsis in critical care |
| Inflammatory control group | – | –Patient admitted for an anesthesia consultation for cardiac surgery under extracorporeal circulation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to critical care for sepsis or septic shock
Key inclusion criteria (4 listed)
- Any adult patient admitted to critical care for sepsis defined by a SOFA score > or = 2 or an increase of at least 2 points if there was organ dysfunction pre-existing to the infection.
- For the inflammatory control group, we will include adult patients who have required extracorporeal circulation for more than 1 hour for cardiac surgery.
- Patients who have read and understood the information letter and do not object to participating in the study
- Patients affiliated with a social security scheme
Key exclusion criteria (9 listed)
- Patient refusal
- Pregnant, parturient, or breastfeeding woman
- Person deprived of liberty by an administrative or judicial decision or person placed under judicial protection/guardianship or curatorship
- Person who does not understand or speak French
- Moribund
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluation of the impact of the immature platelet fraction of patients admitted to intensive care for sepsis or septic shock on their prognosis at day 28.
Time frame: Days 28
Measurement of the fraction of immature platelets at admission in patients with sepsis or septic shock defined by the composite criterion calculated on the occurrence of death at 28 days of follow-up
Evaluation of the impact of the immature platelet fraction of patients admitted to intensive care for sepsis or septic shock on their prognosis at day 28.
Time frame: Days 28
Measurement of the fraction of immature platelets at admission in patients with sepsis or septic shock defined by the composite criterion calculated on the occurrence of organ failure: implementation of extrarenal purification and/or renal failure KDIGO 3 and/or moderate to severe acute respiratory distress syndrome and/or intense vasoplegic septic shock with noradrenaline > 0.25 µg/kg/min or vasopressin > 0.02 IU/h and/or myocardial dysfunction with venous oxygen saturation < 60 or a cardiac index < 2.2 l/min/m2 and/or occurrence of disseminated intravascular coagulation (DIC)
6 secondary outcomes
To assess the impact of the immature platelet fraction on the occurrence of thrombocytopenia
Time frame: days 28
Assess the impact of the immature platelet fraction on the progression to disseminated vascular coagulopathy
Time frame: Days 28
Evaluation of the impact of the immature platelet fraction on the occurrence of thromboembolic events
Time frame: Days 28
Assessment of the occurrence of multiple organ failure syndrome
Time frame: Days 28
Assessment of the occurrence of recourse to mechanical ventilation
Time frame: Days 28
Assessment of mortality in intensive care, in hospital and on D28
Time frame: At enrollment visit, day 1, days 3, days 7 and Days 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 13 Feb 2026.
- Individual participant dataSharing planned: No. The data provided will be the property of the sponsor and will be used solely for its own research activities.
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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.
Perrine PL LEPRETRE, Doctor study director
University Rouen Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Septic Shock, run by University Hospital, Rouen 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 4 inclusion and 9 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 13 Feb 2026. 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. 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?
Evaluation of the impact of the immature platelet fraction of patients admitted to intensive care for sepsis or septic shock on their prognosis at day 28. (time frame: Days 28). 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 13 Feb 2026.