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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Fluid Overload; Critically Ill; Continuous Renal Replacement Therapy; Fluid Removal
• Intervention / Treatment: Other: Macrohemodynamic parameters

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

Study Locations

• France
  • Bron, France, 69500
    • Service d'anesthésie-réanimation, Hôpital Louis Pradel, Hospices Civils de Lyon
    • Contact: RUSTE MARTIN, Dr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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.	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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): February 1, 2026

Study Registration Dates

• First Submitted: May 17, 2024
• First Submitted That Met QC Criteria: May 21, 2024
• First Posted (Actual): May 22, 2024

Study Record Updates

• Last Update Posted (Actual): May 22, 2024
• Last Update Submitted That Met QC Criteria: May 21, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Hemodynamic; Continuous renal replacement therapy; Net ultrafiltration; Fluid removal
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: 69HCL23_5388

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No