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New treatment option for Acute Kidney Injury
Official title Early Deresuscitation Strategy Driven by Tissue Perfusion in Renal Replacement Therapy in Patients With Acute Renal Failure
ClinicalTrials.gov ID: NCT05817539
What this study is testing
- What it's testing
- In Intensive Care Unit (ICU) patients with acute kidney injury (AKI) and treated with renal replacement therapy (RRT) often present a fluid overload which is associated with morbidity (mechanical ventilation duration increase, kidney recovery decrease) and mortality. Patients' prognostic could be improved by correcting the fluid overload with net ultrafiltration (UFnet) however it may lead to harmful iatrogenic hypovolemia responsible of deleterious ischemic lesions.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Acute kidney injury treated by continuous renal replacement therapy in ICU less than 7 days,
- At least 1 organ failure during ICU in addition to AKI (mechanical ventilation or oxygen therapy or vascular filling \> 1000ml or vasopressor...
- Weight loss of less than 3% since starting a net UF or Cumulative UF net less than 2000ml before inclusion,
- Norepinephrine \< 0,5 µg/kg/min,
- Absence of hypoperfusion signs defined by the presence of at least 2 out of 4 criteria:
You likely can't join if
- Chronic renal failure hemodialyzed before admission to the ICU,
- Mechanical circulatory support (ECMO, LVAD),
- Pregnant, child -bearing age or lactating women,
- Stroke based on the combination of central neurological symptoms (aphasia, hemiplegia, hemiparesis) associated with compatible brain imaging, less...
- Intestinal ischemia less than 7 days documented non-operated,
- treatment study participation or exclusion period on going,that may interfere with the present study
See the full eligibility criteria
- Acute kidney injury treated by continuous renal replacement therapy in ICU less than 7 days,
- At least 1 organ failure during ICU in addition to AKI (mechanical ventilation or oxygen therapy or vascular filling \> 1000ml or vasopressor exposure \> 12 hours),
- Weight loss of less than 3% since starting a net UF or Cumulative UF net less than 2000ml before inclusion,
- Norepinephrine \< 0,5 µg/kg/min,
- Absence of hypoperfusion signs defined by the presence of at least 2 out of 4 criteria:
- TRC \> 3s at the finger
- Marbrure score \> 2
- Lactate \> 2 mmol/L
- ScVO2\< 60%,
- Fluid overload defined as follows :
- fluid overload \> 5% of base weight (based on cumulative fluid balance or a weight gain) and/or
- Obvious oedema of the lumbar region or flanks (oedema \> 1cm bucket depth).
- Chronic renal failure hemodialyzed before admission to the ICU,
- Mechanical circulatory support (ECMO, LVAD),
- Pregnant, child -bearing age or lactating women,
- Stroke based on the combination of central neurological symptoms (aphasia, hemiplegia, hemiparesis) associated with compatible brain imaging, less than 30 days,
- Intestinal ischemia less than 7 days documented non-operated,
- treatment study participation or exclusion period on going,that may interfere with the present study
- Guardianship, curatorship or safeguard of justice,
- Absence of signature of free and informed consent by the patient and/or relative,
- Patients not affiliated to a social security scheme or beneficiaries of a similar scheme
The study team makes the final eligibility decision.
Where it's taking place
- Ajaccio, France
- Amiens, France
- Bron, France
- Caen, France
- Dijon, France
- Le Plessis-Robinson, France
- Lille, France
- Lyon, France
- Paris, France
- Vandœuvre-lès-Nancy, France
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ajaccio, France; Amiens, France; Bron, France; Caen, France; Dijon, France; Le Plessis-Robinson, France and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.