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

May 21, 2024 updated by: Hospices Civils de Lyon

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

Study Type

Observational

Enrollment (Estimated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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.

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 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
Time Frame: 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.
Every 6 hours between day 0 to day 5 (intervention period)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Fluid Overload

Clinical Trials on Macrohemodynamic parameters

3
Subscribe