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Macrohemodynamic Impact of Fluid Removal With Net Ultrafiltration in Patients With Continuous Renal Replacement Therapy

Macrohemodynamic Impact of Fluid Removal With Net Ultrafiltration in Patients With Continuous Renal Replacement Therapy: A Monocentric Ancillary Study of the EarlyDry Randomized Controlled Trial

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06425289
Enrollment
60
Registered
2024-05-22
Start date
2024-06-01
Completion date
2026-02-01
Last updated
2024-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Continuous Renal Replacement Therapy, Critically Ill, Fluid Overload, Fluid Removal

Keywords

Fluid removal, Hemodynamic, Net ultrafiltration, Continuous renal replacement therapy

Brief summary

Macrohemodynamic impact of fluid removal with net ultrafiltration in patients with continuous renal replacement therapy. A monocentric ancillary study of the EarlyDry randomized controlled trial.

Interventions

OTHERMacrohemodynamic parameters

Macrohemodynamic parameters will be estimated with transpulmonary thermodilution every 6 hours during the intervention period (5 days). * Cardiac index * Extravascular lung water index * Pulmonary vascular permeability index * Cardiac function index * Global end-diastolic volume index * Central venous pressure * Fluid responsivness status (passive leg rising test)

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion 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 vasopressors administration\>12 hours), * Cumulative UF net less than 1000ml before inclusion, * Norepinephrine \< 0,5 µg/kg/min, * Absence of hypoperfusion signs, * Fluid overload defined as follows: fluid overload \> 5% of base weight (based on cumulative fluid balance or a weight gain) and/or peripheral edema (AKIKI edema scale \> 2).

Exclusion criteria

* Chronic renal failure hemodialyzed before admission to the ICU, * Mechanical circulatory support (ECMO, LVAD), * Pregnant, child -bearing age or lactating women, * Stroke less than 30 days, * Intestinal ischemia less than 7 days documented non-operated, * Interventional study participation or exclusion period on going, * 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 * Absence of transpulmonary thermodilution monitoring

Design outcomes

Primary

MeasureTime frameDescription
Area under the curve of a low cardiac indexEvery 6 hours between day 0 to day 5 (intervention period)Area under the curve of a cardiac index \< 2.4 L/min/m2 (L/min/m2.hr), determined by transpulmonary thermodilution every 6 hours, with three boli of cold saline in the superior vena cava territory.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026