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

NCT06425289 | Not Yet Recruiting

• 1 other identifier: 69HCL23_5388
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (2)

Experimental: Corrective strategy

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.

Other: Macrohemodynamic parameters

Other: Stabilizing strategy In the control group, all patients will have a UFnet 2 ml settled

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.

Other: Macrohemodynamic parameters

Interventions

Macrohemodynamic parameters OTHER

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)

Experimental: Corrective strategy; Other: Stabilizing strategy In the control group, all patients will have a UFnet 2 ml settled

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Critically ill patients with fluid overload and renal replacement therapy for fluid overload, included in EarlyDry trial (NCT05817539) and monitored with transpulmonary thermodilution.

You may qualify 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 vasopressors administration\>12 hours),
• 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).

You may not qualify if:

• 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,
• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Service d'anesthésie-réanimation, Hôpital Louis Pradel, Hospices Civils de Lyon

Bron, 69500, France

Location

MeSH Terms

Conditions

Critical Illness; Edema

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2024
• First Posted: May 22, 2024
• Study Start: June 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: February 1, 2026
• Last Updated: May 22, 2024

Record last verified: 2024-05

Locations

FR (1)