Cardiogenic Acute Pulmonary EdemaGRIEVOUSNCT05881603
Prevalence of Venous conGestion and Its Association With Renal Injuries Evaluated by the VExUS Score On Admission With UltraSound in Patients With Cardiogenic Pulmonary Edema
An observational study of Cardiogenic Acute Pulmonary Edema, run by Centre Hospitalier Universitaire de la Réunion at 1 site in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiogenic Acute Pulmonary Edema
- What is being tested?
- " VExUS score " (Venous Excess Ultrasound Score)
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 20 May 2023to Aug 2025
- 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: Patient with cardiogenic Acute Pulmonary Edema
Who may be able to join
- Age ≥ 18 years old
- Diagnosis of cardiogenic Acute Pulmonary Edema defined by the association of clinical acute respiratory distress (current breath rate > 25/min, indrawing, flapping of the wings of the nose, thoraco-abdominal rocking, signs of hypoxemia, signs of hypercapnia) AND signs of pulmonary overload (clinical, biological and radiological arguments).
- Having given their non-objection to participation in the study (or non-objection of a loved one in an emergency context)
Who cannot join
- Breastfeeding in progress
- Known hypersensitivity to furosemide
- History of kidney transplantation
- Known water and electrolyte disorder
- Hepatic encephalopathy
- Suspicion of obstruction in the urinary tract
- Person deprived of liberty by judicial or administrative decision, minor, person subject to a measure of legal protection
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU de la Réunion
Saint-Denis, 97400
Lucie AUZANNEAU, 0262359949 ext. +262, lucie.auzanneau@chu-reunion.fr
Matthieu DANIEL
About this study
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:
- Oxygen therapy with an Saturation of Hemoglobin with Oxygen (SpO2) target > 94% and the use of non-invasive ventilation (NIV),
- A vasodilator administered intravenously (IV),
- A loop diuretic by IV route. Although most C APE are today considered to occur in a context of hypervolaemia and are uniformly treated by the administration of diuretics according to the recommendations in force, several works underline the fact that a non-negligible part of these clinical pictures would occur in patients with no water and sodium overload but with "relative" hypervolaemia masking euvolaemia or even hypovolaemia.
Read more
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.
- Conditions
- Cardiogenic Acute Pulmonary Edema
- Being tested
- " VExUS score " (Venous Excess Ultrasound Score)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
" VExUS score " (Venous Excess Ultrasound Score)Other
" VExUS score " (Venous Excess Ultrasound Score)
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: within 12 hours of admission
Secondary outcomes (8)
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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: day 7, day 30, day 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2023
- Study start20 May 2023
- Primary completionMay 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiogenic Acute Pulmonary EdemaStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de la Réunion
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05881603
- Sponsor's protocol ID
- 2022/CHU/22
- Other IDs
- 2022-A02815-38
- Acronym
- GRIEVOUS
- Status last verified
- Jun 2023
- First submitted
- 5 May 2023
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Venous conGestion and Its Association With Renal Injuries Evaluated by the VExUS Score On Admission With UltraSound in Patients With Cardiogenic Pulmonary Edema
- ClinicalTrials.gov ID
- NCT05881603
- Acronym / sponsor ID
- GRIEVOUS / 2022/CHU/22
- Conditions
- Cardiogenic Acute Pulmonary Edema
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de la RéunionUniversity, hospital or other
- Study start
- 20 May 2023 (actual)
- Primary completion
- May 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 31 May 2023 (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.
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:
- Oxygen therapy with an Saturation of Hemoglobin with Oxygen (SpO2) target > 94% and the use of non-invasive ventilation (NIV),
- A vasodilator administered intravenously (IV),
- A loop diuretic by IV route. Although most C APE are today considered to occur in a context of hypervolaemia and are uniformly treated by the administration of diuretics according to the recommendations in force, several works underline the fact that a non-negligible part of these clinical pictures would occur in patients with no water and sodium overload but with "relative" hypervolaemia masking euvolaemia or even hypovolaemia.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with cardiogenic Acute Pulmonary Edema
Key inclusion criteria (3 listed)
- Age ≥ 18 years old
- Diagnosis of cardiogenic Acute Pulmonary Edema defined by the association of clinical acute respiratory distress (current breath rate > 25/min, indrawing, flapping of the wings of the nose, thoraco-abdominal rocking, signs of hypoxemia, signs of hypercapnia) AND signs of pulmonary overload (clinical, biological and radiological arguments).
- Having given their non-objection to participation in the study (or non-objection of a loved one in an emergency context)
Key exclusion criteria (7 listed)
- Breastfeeding in progress
- Known hypersensitivity to furosemide
- History of kidney transplantation
- Known water and electrolyte disorder
- Hepatic encephalopathy
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 |
|---|---|---|
| " VExUS score " (Venous Excess Ultrasound Score)" VExUS score " (Venous Excess Ultrasound Score) | Other | – |
Primary outcome
Estimate the prevalence of the different grades of venous congestion assessed by the VExUS score in ultrasound
Time frame: within 12 hours of admission
VExUS score in ultrasound score 0 to 3 / Higher score means worse outcome
8 secondary outcomes
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
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
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
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
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
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
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
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
Time frame: day 7, day 30, day 180
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
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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.
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 Cardiogenic Acute Pulmonary Edema, run by Centre Hospitalier Universitaire de la Réunion 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 3 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 22 Jun 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lucie AUZANNEAU (0262359949 ext. +262, lucie.auzanneau@chu-reunion.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Estimate the prevalence of the different grades of venous congestion assessed by the VExUS score in ultrasound (time frame: within 12 hours of admission). 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 22 Jun 2023.