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

Critically Ill Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06425289
• Other study ID #: 69HCL23_5388
• Status: Not yet recruiting
• Start date: June 1, 2024
• Est. completion date: February 1, 2026

Study information

• Verified date: May 2024
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: February 1, 2026
• Est. primary completion date: December 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Continuous Renal Replacement Therapy
• Critical Illness
• Critically Ill
• Fluid Overload

Intervention

Other:
• Macrohemodynamic 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)

Locations

Country	Name	City	State
France	Service d'anesthésie-réanimation, Hôpital Louis Pradel, Hospices Civils de Lyon	Bron

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the curve of a low cardiac index	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.	Every 6 hours between day 0 to day 5 (intervention period)