Sepsis and Septic ShockALBUREANCT06476860
Proteinuria During Sepsis and Septic Shock: Characterization and Association With ARDS
An observational study of Sepsis and Septic Shock, run by Centre Hospitalier Intercommunal André Grégoire at 1 site in France.
Trial summary
ARDS is a pulmonary edema injury. Among its etiologies, it can be secondary to septic shock. Managing septic shock involves hemodynamic optimization with significant fluid and sodium inputs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis and Septic Shock
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 23 May 2023to Jun 2024
- 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: All adult patients suspected of sepsis or septic shock until 100 patients are enrolled. Infection diagnosis is based on systemic clinical signs (fever) or local inflammatory signs, biological evidence, and suspicion or confirmation of an infectious agent. The diagnosis of sepsis involves infection accompanied by organ failure, which may manifest as cardiovascular, respiratory, neurological, metabolic, renal, coagulation, or hepatic impairment. These signs may precede hypotension or occur without it.
Who may be able to join
- All patients aged 18 and older admitted to the intensive care unit for suspected sepsis or septic shock.
Who cannot join
- Minors or opposition to participation.
- Chronic dialysis patients
- Organ transplant recipients
- Confirmed urinary tract infection
- Subject with macroscopic hematuria
- Pregnant woman
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Proteinuria During Sepsis and Septic Shock: Characterization and Association With Acute Respiratory Distress Syndrome
ARDS is a pulmonary edema injury. Among its etiologies, it can be secondary to septic shock. Managing septic shock involves hemodynamic optimization with significant fluid and sodium inputs. Fluid and sodium inputs in ARDS worsen respiratory failure through capillary leakage, and a restrictive input strategy is clinically beneficial (reduced mechanical ventilation duration and ICU stay). Predicting ARDS onset in septic shock allows for optimized fluid and sodium input management, adopting a restrictive rather than liberal approach to minimize deterioration in respiratory function.
Read the detailed description
Septic shock remains highly fatal, causing multi-organ failure including hemodynamic, pulmonary, neurological, renal, hematologic, and hepatic. These failures stem from generalized inflammatory aggression leading to endothelial dysfunction, especially at the capillary level. Pulmonary failure secondary to septic shock is characterized by edema, with ARDS being the most severe form. Sepsis is the second most common cause of ARDS after pneumonia. The incidence of ARDS in severe sepsis is about 6%, and its occurrence is an independent factor contributing to increased mortality.
These failures significantly impact the management of septic shock, where early and often agressive, vascular filling is standard for hemodynamic failure. Conversely, the onset of ARDS onset warrants limiting hydro-sodium inputs. Currently, there are no data predicting the occurrence of ARDS patients with septic shock.
- Conditions
- Sepsis and Septic Shock
- Keywords
- proteinuria, septic shock, sepsis, Acute Respiratory Distresse Syndrome
- Medical subject headings
- Sepsis, Shock, Septic, Proteinuria
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 |
|---|---|---|
| patients suspected of sepsis or septic shock | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of proteinuria in the first 24 hours (H0 and H24) of septic shock.
relationship between proteinuria kinetics in the first 24 hours (H0 and H24) of septic shock and presence of ARDS at H72
Measured: 24 hours
Secondary outcomes (3)
measurement of albuminuria urinary IgG at H0 and H24
Evaluation of the association between proteinuria kinetics and the onset of hemodynamic failure, renal failure, duration of mechanical ventilation, ICU stay, and hospital mortality
Measured: 24 hours
measurement of alpha-1-microglobulin at H0 and H24
Evaluation of the association between proteinuria kinetics and the onset of hemodynamic failure, renal failure, duration of mechanical ventilation, ICU stay, and hospital mortality
Measured: 24 hours
measurement of urinary IgG at H0 and H24
Evaluation of the association between proteinuria kinetics and the onset of hemodynamic failure, renal failure, duration of mechanical ventilation, ICU stay, and hospital mortality
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2024
- Study start23 May 2023
- Primary completionJun 2024 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sepsis and Septic ShockStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Intercommunal André Grégoire
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06476860
- Sponsor's protocol ID
- GHT_CHIM RNI20221130
- Acronym
- ALBUREA
- Status last verified
- May 2024
- First submitted
- 30 May 2024
- Last updated
- 27 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Iba T, Levy JH. Derangement of the endothelial glycocalyx in sepsis. J Thromb Haemost. 2019 Feb;17(2):283-294. doi: 10.1111/jth.14371. Epub 2019 Feb 3.
PubMed 30582882
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proteinuria During Sepsis and Septic Shock: Characterization and Association With Acute Respiratory Distress Syndrome
- ClinicalTrials.gov ID
- NCT06476860
- Acronym / sponsor ID
- ALBUREA / GHT_CHIM RNI20221130
- Conditions
- Sepsis and Septic Shock
- Keywords
- proteinuria, septic shock, sepsis, Acute Respiratory Distresse Syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Centre Hospitalier Intercommunal André GrégoireUniversity, hospital or other
- Study start
- 23 May 2023 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 27 Jun 2024 (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.
ARDS is a pulmonary edema injury. Among its etiologies, it can be secondary to septic shock. Managing septic shock involves hemodynamic optimization with significant fluid and sodium inputs. Fluid and sodium inputs in ARDS worsen respiratory failure through capillary leakage, and a restrictive input strategy is clinically beneficial (reduced mechanical ventilation duration and ICU stay). Predicting ARDS onset in septic shock allows for optimized fluid and sodium input management, adopting a restrictive rather than liberal approach to minimize deterioration in respiratory function.
Detailed description
Septic shock remains highly fatal, causing multi-organ failure including hemodynamic, pulmonary, neurological, renal, hematologic, and hepatic. These failures stem from generalized inflammatory aggression leading to endothelial dysfunction, especially at the capillary level. Pulmonary failure secondary to septic shock is characterized by edema, with ARDS being the most severe form. Sepsis is the second most common cause of ARDS after pneumonia. The incidence of ARDS in severe sepsis is about 6%, and its occurrence is an independent factor contributing to increased mortality.
These failures significantly impact the management of septic shock, where early and often agressive, vascular filling is standard for hemodynamic failure. Conversely, the onset of ARDS onset warrants limiting hydro-sodium inputs. Currently, there are no data predicting the occurrence of ARDS patients with septic shock.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients suspected of sepsis or septic shock | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult patients suspected of sepsis or septic shock until 100 patients are enrolled. Infection diagnosis is based on systemic clinical signs (fever) or local inflammatory signs, biological evidence, and suspicion or confirmation of an infectious agent. The diagnosis of sepsis involves infection accompanied by organ failure, which may manifest as cardiovascular, respiratory, neurological, metabolic, renal, coagulation, or hepatic impairment. These signs may precede hypotension or occur without it.
Key inclusion criteria (1 listed)
- All patients aged 18 and older admitted to the intensive care unit for suspected sepsis or septic shock.
Key exclusion criteria (6 listed)
- Minors or opposition to participation.
- Chronic dialysis patients
- Organ transplant recipients
- Confirmed urinary tract infection
- Subject with macroscopic hematuria
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
Measurement of proteinuria in the first 24 hours (H0 and H24) of septic shock.
Time frame: 24 hours
relationship between proteinuria kinetics in the first 24 hours (H0 and H24) of septic shock and presence of ARDS at H72
3 secondary outcomes
measurement of albuminuria urinary IgG at H0 and H24
Time frame: 24 hours
measurement of alpha-1-microglobulin at H0 and H24
Time frame: 24 hours
measurement of urinary IgG at H0 and H24
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2024.
- Results publication: PubMed 30582882Iba T, Levy JH. Derangement of the endothelial glycocalyx in sepsis. J Thromb Haemost. 2019 Feb;17(2):283-294. doi: 10.1111/jth.14371. Epub 2019 Feb 3.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Sepsis and Septic Shock, run by Centre Hospitalier Intercommunal André Grégoire 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 1 inclusion and 6 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 27 Jun 2024. 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?
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?
Measurement of proteinuria in the first 24 hours (H0 and H24) of septic shock. (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06476860, which also lists 1 linked publication.
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 27 Jun 2024.