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
• Interventions: Other: Macrohemodynamic parameters

• 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

Arm && Interventions

Group	Intervention	Description
Other: Stabilizing strategy In the control group, all patients will have a UFnet 2 ml settled	Macrohemodynamic parameters	Procedure: Body weight Stabilization During the RRT, UFnet will be settled between 0 et 1 ml/kg/h and adapted in case of weight stabilization failure or hemodynamic intolerance. In case of weight stabilisation failure (variation \>5%), the UF net can be increased to 1,5 ml/kg/h. In case of hemodynamic intolerance (NADN \> 0,5 µg/kg/min), UF net will be stopped during 6 hours and restarted if NADN \< 0,5 µg/kg/min.
Experimental: Corrective strategy	Macrohemodynamic parameters	Procedure: Fluid balance negativation During the RRT, UFnet will be settled on 2ml/kg/h and adapted to hemodynamic tolerance and tissue perfusion . When the patient's baseline body weight is reached the UF net will be settled to maintain it. In case of failure of the fluid balance negativation after 24h, UFnet will be settled on 3ml/kg/h. Then when the baseline body weight is reached UFnet will be settled on 0.5 et 1ml/kg/h or if necessary adapted to 1,5ml/kg/h to maintain it In case of hemodynamic intolerance (NADN \> 0,5 µg/kg/min) or tissue hypoperfusion, UF net will be stopped during 6 hours and restarted if NADN \< 0,5 µg/kg/min and without tissue hypoperfusion.

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