Not yet recruiting NCT07039487
EVALUATION OF NEUTROPHIL FLUORESCENCE IN PATIENTS WITH DISSEMINATED INTRAVASCULAR COAGULATION ASSOCIATED WITH SEPTIC SHOCK
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Blood sampling collection.
- Who it may be relevant to
- Registry conditions: DISSEMINATED INTRAVASCULAR COAGULATION ASSOCIATED WITH SEPTIC SHOCK. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
Neutrophil fluorescence could be a reliable and early diagnostic marker of disseminated intravascular coagulation septic DIC, which can be used routinely. The objective of the investigators is to define the optimal threshold of neutrophil fluorescence associated with a sensitivity of at least 90% for the diagnosis of DIC.
Interventions
- Other Blood sampling collection
CBC performed on the background of an EDTA tube, collected routinely allowing neutrophil fluorescence measurements. This tube will then be passed over on the automaton for a CBC measurement with leukocyte differentiation.
Primary outcome measures
- Define the optimal threshold for neutrophil fluorescence (measured at admission of the patient to intensive care on a new automaton) associated with a sensitivity of at least 90% for the diagnosis of disseminated intravascular coagulation DIC. [Time frame: 1 month]
Secondary outcome measures (6)
- To estimate the performance indicators of neutrophil fluorescence measured a new automaton.at admission of the patient to the ICU for all relevant thresholds. [Time frame: 1 month]
- To estimate the performance indicators of neutrophil fluorescence measured a new automaton.at admission of the patient to the ICU for all relevant thresholds. [Time frame: 1 month]
- To estimate the performance indicators of neutrophil fluorescence measured a new automaton.at admission of the patient to the ICU for all relevant thresholds. [Time frame: 1 month]
- To estimate the performance indicators of neutrophil fluorescence measured a new automaton.at admission of the patient to the ICU for all relevant thresholds. [Time frame: 1 month]
- To estimate the performance indicators of neutrophil fluorescence measured a new automaton.at admission of the patient to the ICU for all relevant thresholds. [Time frame: 1 month]
- To compare the areas under the partial ROC (receiver operating characteristic) curve (for a sensitivity greater than or equal to 90%) illustrating the performance of neutrophil fluorescence measured at the patient's admission to the ICU in the diagnosis [Time frame: 1 month]
Eligibility criteria
Inclusion criteria
- Male or female ≥ 18 years of age
- Patient admitted to intensive care for septic shock
- Patient affiliated to a social security scheme or entitled to it
- Non-opposition by the patient or a relative in the event that the patient is not in a state to express his or her consent or inclusion in an emergency procedure in the event that the patient is not in a state to express his or her opinion and no relative of the patient can be reached.
Exclusion criteria
- Dying patient on the day of inclusion
- Cirrhosis Child Pugh C
- Neutropenia (<500 mm3)
- Patient under judicial protection
- Patient under guardianship or curatorship
- Pregnancy
- Breastfeeding
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- Service de Médecine Intensive - Réanimation Nouvel Hôpital Civil — Strasbourg
Identifiers
NCT: NCT07039487 · 9556 · 2024-A02853-44