- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06899880
Perfusion Parameters and Outcome During a Standardized Deresuscitation Strategy with Net Ultrafiltration: a Retrospective Cohort Study. (DeepCART)
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
Status
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
Bron
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France, Bron, France, 69500
- Louis Pradel Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
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
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.
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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:
|
A day 30 after the initiation of the deresuscitation strategy
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 24-5563
Drug and device information, study documents
product manufactured in and exported from the U.S.
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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