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

Not yet recruiting

• Conditions: Fluid Removal; Continuous Renal Replacement Therapy; Critically Ill; Fluid Overload

• Registration Number: NCT06425289
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-05
• Study First Submitted: 2024-05-17
• Study First Submitted QC: 2024-05-21
• Last Update Submitted: 2024-05-21
• Study First Posted: 2024-05-22
• Last Update Posted: 2024-05-22
• Study Start: 2024-06-01
• Primary Completion: 2025-12-01
• Study Completion: 2026-02-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Area under the curve of a low cardiac index	Every 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.

Trial Locations

Locations (1)

Service d'anesthésie-réanimation, Hôpital Louis Pradel, Hospices Civils de Lyon; 🇫🇷 Bron, France