An observational study in Necrotizing Fascitis, Cellulitis and Septic Shock, sponsored by University Hospital, Lille. Not yet recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-14.
Sponsored by University Hospital, Lille · Observational
The central venous-arterial carbon dioxide tension difference is used daily in intensive care to establish peripheral tissue hypoperfusion, mainly mediated by a low cardiac index.
The partial pressures of gases (oxygen, carbon dioxide) increase in the blood of patients breathing 100% oxygen in hyperbaric conditions.
Thus, the validity of this biomarker in situations of acute circulatory failure during a hyperbaric oxygen therapy session has not been established.
The objective of the study is therefore to establish the diagnostic performance of the central venous-arterial carbon dioxide tension difference in the diagnosis of a low cardiac index in patients with septic shock undergoing hyperbaric oxygen therapy for necrotizing fasciitis.
Adult patients diagnosed with necrotizing fasciitis and receiving OHB treatment for the first time will be offered participation in the study if they meet the following inclusion criteria:
28 studies on the registry are indexed under Fasciitis, Necrotizing; 8 are open to participants now.
This study's planned enrollment of 74 is below the median of 152 across 16 observational studies indexed under Fasciitis, Necrotizing.
Browse Fasciitis, Necrotizing studies →University Hospital, Lille is the lead sponsor of 631 studies on the registry; 142 are open to participants now.
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Adult patients diagnosed with necrotizing dermo-hypodermitis who are receiving OHB treatment for the first time at the Regional Hyperbaric Oxygen Therapy Center at Lille University Hospital, a tertiary referral center where complementary hyperbaric oxygen therapy treatment for necrotizing dermo-hypodermitis in the Hauts-de-France region is centralized.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Relative contraindication to hyperbaric oxygen therapy
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adult patients diagnosed with necrotizing fasciitis and receiving OHB treatment for the first time will be offered participation in the study if they meet the following inclusion criteria: * Diagnosis of necrotizing fasciitis complicated by septic shock as defined by the Surviving Sepsis Campaign * Indication for HBOT according to the criteria of the 2016 European Consensus Conference * Patient intubated and ventilated prior to the HBOT session, receiving intravenous sedation at doses sufficient to be in a passive ventilation state * Patient equipped with a central venous line in the superior vena cava allowing central venous blood gas analysis * Patient with an arterial catheter allowing arterial blood gas analysis
Other: Echography
Cardiac output is estimated by taking three measurements of the time-velocity integral using pulsed Doppler at the level of the left ventricular outflow tract, known as the subaortic time-velocity integral (TVI). The systolic ejection volume is calculated by multiplying the subaortic TVI by the area of the aortic outflow tract diameter. Cardiac output is calculated by multiplying this systolic ejection volume by the patient's heart rate. The cardiac index is calculated by dividing cardiac output by the patient's calculated body surface area. Blood gas sampled from central arterial and venous catheters at the four stages of the experimental plan Cardiac output and blood gases will be measured: * After 15 minutes of ventilation on a hyperbaric ventilator at ambient pressure in the chamber with FIO2 equivalent to that of the intensive care unit (T0). * After 15 minutes at maximum treatment pressure, i.e., 2.5 ATA under FIO2 at 1 (T1) * After 75 minutes at the plateau following the star
Area under the receiver operating characteristic (ROC) curve constructed from central venous-arterial carbon dioxide tension difference measurements
used to define low cardiac output measured as a cardiac index \< 2.2 L/min/m² by cardiac echocardiography under hyperbaric oxygenation conditions after 15 min at the maximum treatment pressure of 2.5 ATA under FIO2 at 1 (T1) Maximum treatment pressure i.e., 2.5 ATA under FIO2 at 1
Time frame: After 15 minutes at maximum treatment pressure (T1)
Evaluate the concordance at different time points (T0, T1, T2, and T3) between the definition of low cardiac output by cardiac index <2.2 L/min/m² (gold standard) and the Pvc-aCO2 value according to the threshold of 6 mmHg.
The concordance between the two variables will be measured using Cohen's Kappa coefficient for each of the four time points.
Time frame: After 15 minutes at ambiant pressure in the hyperbaric chamber (T0), after 15 minutes at 2.5 ATA under FIO2 at 1 (T1), after 75 minutes following the start of the session (T2), and 15 minutes after the end of HBOT session (T3)
Compare cardiac index values measured at T0, T1, T2, and T3 according to three pre-specified groups classified according to Pvc-aCO2 values established by Ospina-Tasco´n et al.: < 6 mmHg; (2) 6.0-9.9 mmHg; (3) ≥ 10 mmHg.
The cardiac index will be measured by cardiac echocardiography under hyperbaric oxygenation conditions. The three groups will be determined according to Pvc-aCO2 values established by Ospina-Tasco´n et al.: (1) \< 6 mmHg; (2) 6.0-9.9 mmHg; (3) ≥ 10 mmHg.
Time frame: After 15 minutes at ambiant pressure in the hyperbaric chamber (T0), after 15 minutes at 2.5 ATA under FIO2 at 1 (T1), after 75 minutes following the start of the session (T2), and 15 minutes after the end of HBOT session (T3)
Evaluate the performance of transcutaneous oximetry variations from the subclavian reference electrode after passive leg raising, a non-invasive procedure, as a diagnostic tool for preload dependence.
Area under the receiver operating characteristic (ROC) curve contructed from measurements of transcutaneous oximetry variationsbefore and after passive leg raising (ΔPTcO2). A patient will be considered "preload dependent" if the subaortic ITV measured by echocardiography varies by sup \> 10 % under hyperbaric oxygenation conditions after 15 minutes at the maximumtreatment pressure of 2.5 ATA under FIO2 at 1 (T1). The correlation between ΔPTcO2 and the variation in subaortic ITV measured by echocardiography after passive legraising will so also measured.
Time frame: After 15 minutes at maximum treatment pressure (T1)
Describe clinical parameters related to blood pressures, echocardiographic data and respiratory mechanics changes induced in patients admitted for necrotizing fasciitis complicated by septic shock under hyperbaric oxygen therapy.
at each time point (T0, T1, T2, and T3), will be measured : * Systolic/diastolic/mean arterial pressures * Heart rate * Systolic/diastolic/mean pulmonary arterial pressures estimated by transthoracic echocardiography * End-expiratory central venous pressure by transthoracic echocardiography through analysis of the inferior vena cava. * Cardiac index estimated by echocardiography * TAPSE and S' wave, * Mitral flow analysis * Indexed systemic vascular resistance estimated using Ohm's law. (PAM-PVC)/IC * Indexed pulmonary vascular resistance estimated using the formula : RPT = 10 (Vmax IT/VTI p) + 0.16 * Right ventriculo-arterial coupling measured by the TAPSE/PAPs ratio * Tidal volume relative to theoretical ideal weight * Adjusted external PEEP and total PEEP * Driving pressure measured as plateau pressure minus total PEEP * Respiratory system compliance measured as Vt/(Pplat - total PEEP) * R/I ratio: recruitment-to-inflation ratio * Airway opening pressure
Time frame: After 15 minutes at ambiant pressure in the hyperbaric chamber (T0), after 15 minutes at 2.5 ATA under FIO2 at 1 (T1), after 75 minutes following the start of the session (T2), and 15 minutes after the end of HBOT session (T3)
Plan to share: No
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