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

NCT ID: NCT06425289

Last Updated: 2024-05-22

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-06-01
• Study Completion Date: 2026-02-01

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

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Macrohemodynamic parameters

Intervention Type: 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)

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.

Macrohemodynamic parameters

Intervention Type: 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)

Interventions

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)

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Bron, , France

Countries

France

Facility Contacts

RUSTE MARTIN, Dr

Role: primary

Other Identifiers

69HCL23_5388

Identifier Type: -

Identifier Source: org_study_id