Perfusion Parameters and Outcome During a Standardized Deresuscitation Strategy with Net Ultrafiltration: a Retrospective Cohort Study. (DeepCART)

March 21, 2025 updated by: Hospices Civils de Lyon

Hemodynamic tolerance of fluid removal during deresuscitation is a cornerstone of the impact on outcome of such a strategy. However, how to define and to predict hemodynamic tolerance to fluid removal remains controversial. The investigators routinely use a standardized deresuscitation protocol in patients with fluid overload and continuous renal replacement therapy combined with monitoring of clinical and biological perfusion parameters.

The aim of the study was to describe perfusion during deresuscitation, and to determine whether it is associated with major adverse kidney events at day 30.

Study Overview

Study Type

Observational

Enrollment (Actual)

120

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, Bron, France, 69500
        • Louis Pradel Hospital

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

N/A

Sampling Method

Non-Probability Sample

Study Population

adults' patients with fluid overload and continuous renal replacement therapy in intensive care unit

Description

Inclusion Criteria:

  • Age ≥ 18 years old
  • Acute kidney injury requiring continuous renal replacement therapy
  • Standardized deresuscitation following a routine care protocol

Exclusion Criteria:

  • Chronic hemodialysis
  • Advanced directives to withhold or withdraw life-sustaining treatment,
  • Patient's opposition to the use of his/her personal health data

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
Standardized deresuscitation strategy
Eligible patients without hypoperfusion benefited from: 1) a restrictive approach of intakes combining hypercaloric enteral or per os feeding with hydric restriction as much as possible and no fluid of maintenance, and 2) a systematic UFnet of 2 mL/kg/h until reaching dry weight and a systematic monitoring every 6 h of: peripheral perfusion by capillary refilling time and mottling score, arterial lactate level, and central venous oxygen saturation.
Arterial lactate, pCO2 gap, SvO2, capillary refill time and mottling score anomalies will be described during the first 5 days of the deresuscitation strategy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MAKE 30
Time Frame: A day 30 after the initiation of the deresuscitation strategy

Major adverse kidney event at day 30, defined as follows:

  • Death OR
  • No weaning of renal replacement therapy OR
  • Serum creatinine > 2 times baseline serum creatinine
A day 30 after the initiation of the deresuscitation strategy

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 (Actual)

January 1, 2024

Primary Completion (Actual)

March 1, 2024

Study Completion (Actual)

April 1, 2024

Study Registration Dates

First Submitted

March 21, 2025

First Submitted That Met QC Criteria

March 21, 2025

First Posted (Actual)

March 28, 2025

Study Record Updates

Last Update Posted (Actual)

March 28, 2025

Last Update Submitted That Met QC Criteria

March 21, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Drug and device information, study documents

product manufactured in and exported from the U.S.

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.

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