Early Dry Cohort : Impact on the Fluid Balance of a Perfusion Based Protocol to Adjust UFnet During Deresuscitation in Intensive Care Unit.

Completed

• Conditions: Acute Kidney Injury
• Interventions: Other: Early Dry protocol

• Registration Number: NCT05119361
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

Fluid overload is frequent and associated with mortality in critically ill patients, especially those with acute kidney injury. If fluid loading is a cornerstone of a resuscitation strategy, some authors promote an evacuation phase to limit the fluid overload exposure (deresuscitation strategy). In patients with continuous renal therapy, often presenting an inadequate diuresis, it includes the net ultrafiltration setting. A potential side effect of deresuscitation strategy is to induce iatrogenic hypovolemia.

We have implemented a perfusion-based protocol to induce systematic early fluid removal on patients after haemodynamic stabilization. We would like to observe the impact on the fluid balance of such a protocol and to explore the recruitment capacity of our centre and exploratory outcomes to lead a future randomized control study.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2021-07-01
• Primary Completion: 2021-08-01
• Study Completion: 2021-09-01
• Study First Submitted: 2021-11-02
• Study First Submitted QC: 2021-11-02
• Study First Posted: 2021-11-15
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-02
• Last Update Posted: 2022-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• • Age ≥ 18 ans
• Acute kidney injury with continuous renal replacement therapy
• Fluid overload > 5%
• Equivalent Norepinephrine dose < 0,5 µg/kg/min

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Exclusion Criteria

• • Chronic intermittent haemodialysis
• Active bleeding
• Stroke with coma
• Pregnancy
• advanced directives to withhold or withdraw life-sustaining treatment
• patient's opposition to the use of his/her personal health data."

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
before protocol implementation	Early Dry protocol	A control group reflecting usual practice about net ultrafiltration and deresuscitation strategy in patients with continuous renal replacement therapy in our Department. All patients meeting eligibility criteria between 01/01/2020 and 31/12/2021 will be include.
after protocol implementation	Early Dry protocol	All patients treated by our deresuscitation protocol between 15/02/2020 and 15/08/2021 will be included.

Primary Outcome Measures

Name	Time	Method
Computed cumulative fluid balance (mL) at day 5 after protocol onset.	Day 5 after protocol onset.	Cumulative between input and output, defined as follow: * Input = cumulative volume of: * Medication; * Enteral and parenteral feeding; * Fluid loading; * Transfusion products; * Output = cumulative volume of: * diuresis; * surgical drainage; * net ultrafiltration

Trial Locations

Locations (1)

Hôpital cardiologique Louis Pradel - HCL; 🇫🇷 Bron, France