An observational study in Cardiogenic Acute Pulmonary Edema, sponsored by Centre Hospitalier Universitaire de la Réunion. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-06-22.
Sponsored by Centre Hospitalier Universitaire de la Réunion · Observational
Among 22 studies in Pulmonary Edema with a site in France — 6 open to participants now, 6 under way, none of them phase 3. Pulmonary Edema · France.
Among the 22 studies in Pulmonary Edema with a site in France, this one is one of 3 that started in 2023, is one of 8 observational ones, and was the 17th registered.
126 studies on the registry are indexed under Pulmonary Edema; 27 are open to participants now.
This study's planned enrollment of 100 is below the median of 120 across 55 observational studies indexed under Pulmonary Edema.
Browse Pulmonary Edema studies →6 of the 22 studies in Pulmonary Edema with a site in France are open now, in 1 country. Each count lists the studies.
Of the 20 Pulmonary Edema studies recruiting now, 18 (90%) set no upper age limit and 1 (5%) stop at 75 or younger; 2 take children under 18; 5 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →22 studies; the count open now beside each. This study's row is marked.
First in 2002; this study’s year is marked. 3 started in 2023.
Median enrollment 79 across the 12 interventional studies, 100 across the 8 observational. Of the 10 that completed or were terminated, 0 (0%) have results posted.
None of the 22 has an industry lead sponsor. The 10 most frequent:
Centre Hospitalier Universitaire de la Réunion is the lead sponsor of 141 studies on the registry; 37 are open to participants now.
Centre Hospitalier Universitaire de la Réunion has 1 study filed under Pulmonary Edema — fewer than ten, so there is no comparison to draw.
1 of the studies in Pulmonary Edema with a site in France that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06923267Centre Hospitalier Régional d'OrléansUltrasound Evaluation of Cardiac Function During Spontaneous Breathing Trials | 2027-04-09 |
Among the 22 studies in Pulmonary Edema with a site in France, from their registry updates:
Nothing recorded among them since 2026-09-25.
Acute respiratory distress (ARD) is a frequent reason for seeking care in emergency medicine and represents an important cause of morbidity and mortality. Among the various etiologies, Acute Cardiogenic Pulmonary Edema (C APE) currently represents one of the main causes of ARD, particularly in the elderly, with a prevalence of 43% and an estimated mortality of 21%. According to the recommendations issued in 2021 by the European Society of Cardiology (ESC), the treatment of cardiogenic APE is currently based on a triptych combining:
At present, no additional examination is recommended to determine the patient's volume status. However, it has been shown more recently that some patients who do not have absolute hypervolaemia could develop acute renal complications during treatment for C APE. In addition, systematic treatment with loop diuretics in patients without absolute hypervolaemia could be harmful by inducing post-treatment hypovolaemia.
At the present time, there are no data from the literature having been interested in the possible association existing between the state of blood volume of the patient on admission and the occurrence of renal complications in the aftermath of the treatment. initial. The prevalence of renal complications was nevertheless evaluated at 9% in this category of patients. The estimated prevalence of this complication and its particular seriousness, particularly in the case of chronic acute kidney injury, as well as its cost to society, justify carrying out a study aimed at evaluating the prevalence of venous congestion in the acute phase and of its possible association with the occurrence of renal complications in the course of this.
Among the various methods for assessing blood volume status, there is a growing literature regarding the use of clinical ultrasound in emergency medicine (ECMU). More recently, an ultrasound score called "VExUS score" (Venous Excess Ultrasound Score) has been developed. This offers the possibility of evaluating and classifying in 4 grades of increasing severity, simply and quickly, the state of venous congestion of patients. This score is based on the presence or absence of venous Doppler ultrasound abnormalities assessed at the level of the inferior vena cava, at the level of the supra-hepatic veins, of the portal and renal venous flow. This score, adapted to the practice of ECMU and making it possible to distinguish patients with or without venous congestion criteria, could provide arguments to guide diuretic treatment by offering personalized care. This evaluation would ultimately make it possible to offer diuretic treatment only in the event of signs suggestive of absolute hypervolaemia and thus avoid the occurrence of complications related to inappropriate therapy.
Patient with cardiogenic Acute Pulmonary Edema
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:
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.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
" VExUS score " (Venous Excess Ultrasound Score)
Estimate the prevalence of the different grades of venous congestion assessed by the VExUS score in ultrasound
VExUS score in ultrasound score 0 to 3 / Higher score means worse outcome
Time frame: within 12 hours of admission
Evaluate the association between the different ultrasound grades of venous congestion described by the ultrasound VExUS score and the occurrence of renal complications during hospitalization defined by the MAKE-Discharge
Major Adverse Kidney Events (MAKE), composite criterion : - Criterion 1 : De novo acute renal failure (ARI) or worsening of pre-existing chronic renal failure (CRI), defined according to the Kidney Disease: Improving Global Outcomes (KDIGO) reference classification
Time frame: 7 days, 30 days, 180 days
Evaluate the association between the different ultrasound grades of venous congestion described by the ultrasound VExUS score and the occurrence of renal complications during hospitalization defined by the MAKE-Discharge
Major Adverse Kidney Events (MAKE), composite criterion : * Criterion 2 : Need for de novo extra-renal purification (ERT) or increased frequency of use of ERT or need for emergency ERT in a patient usually on dialysis, * Occurrence of a death.
Time frame: 7 days, 30 days, 180 days
Evaluate the association between the different ultrasound grades of venous congestion described by the ultrasound VExUS score and the occurrence of renal complications during hospitalization defined by the MAKE-Discharge
Major Adverse Kidney Events (MAKE), composite criterion : * Criterion 3 : Occurence of death * Occurrence of a death.
Time frame: 7 days, 30 days, 180 days
Assess the association between the grade of the VExUS ultrasound score on admission and the total and daily dose of furosemide administered to the patient
dose of furosemide
Time frame: 7 days
Evaluate the kinetics of evolution of the VExUS ultrasound score performed at the patient's bedside in comparison with the values found on admission
VExUS score in ultrasound score 0 to 3 / Higher score means worse outcome
Time frame: within 12 hours of admission , day 3 day 7
Evaluate the association between the presence of venous congestion (VExUS score ≥ 1) or not and vital and functional status : Gerontological autonomy iso-resource groups
Gerontological autonomy iso-resource groups (score AGGIR) Value 1 to 6 / Higher score mean better outcome
Time frame: day 7, day 30, day 180
Evaluate the association between the presence of venous congestion (VExUS score ≥ 1) or not and vital and functional status : Activities of daily living
Activities of daily living (score ADL) Value 1 to 6 / Higher score mean better outcome
Time frame: day 7, day 30, day 180
Evaluate the association between the presence of venous congestion (VExUS score ≥ 1) or not and vital and functional status : Barthel Index
Barthel Index Value 0 to 100 / Higher score mean better outcome
Time frame: day 7, day 30, day 180
Started May 2023 (actual). Primary completion is estimated for May 2025, 24 months after the start.
Of 27 observational studies under Pulmonary Edema, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 57. This study's planned 24 months is below that.
How these figures are worked out, and which studies are left out of them.
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