NCT06899880

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2024

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

March 21, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 28, 2025

Completed
Last Updated

March 28, 2025

Status Verified

March 1, 2025

Enrollment Period

2 months

First QC Date

March 21, 2025

Last Update Submit

March 21, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • MAKE 30

    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

Study Arms (1)

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.

Other: Describe the perfusion parameters during a deresuscitation strategy and their association with the outcome.

Interventions

Arterial lactate, pCO2 gap, SvO2, capillary refill time and mottling score anomalies will be described during the first 5 days of the deresuscitation strategy.

Standardized deresuscitation strategy

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Louis Pradel Hospital

France, Bron, 69500, France

Location

MeSH Terms

Conditions

EdemaAcute Kidney Injury

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 21, 2025

First Posted

March 28, 2025

Study Start

January 1, 2024

Primary Completion

March 1, 2024

Study Completion

April 1, 2024

Last Updated

March 28, 2025

Record last verified: 2025-03

Locations