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

NCT05119361 | Completed

• 1 other identifier: 454
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Kidney Injury

Keywords

ultrafiltration; deresuscitation; fluid overload; fluid balance.

Outcome Measures

Primary Outcomes (1)

• Computed cumulative fluid balance (mL) at 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

  Day 5 after protocol onset.

Study Arms (2)

before protocol implementation

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.

Other: Early Dry protocol

after protocol implementation

All patients treated by our deresuscitation protocol between 15/02/2020 and 15/08/2021 will be included.

Other: Early Dry protocol

Interventions

Early Dry protocol OTHER

After meeting eligibility criteria, patients have a net ultrafiltration of 2mL/kg/h with systematic perfusion monitoring (lactate concentration, central venous saturation, mottling score and capillary refill time) and restrictive input. If the patient presents hypoperfusion (at least to sign), net ultrafiltration is stopped and haemodynamic optimized. If the patient presents pulmonary oedema or right ventricular failure, with venous congestion, ultrafiltration is set at 3mL/kg/h. Ultrafiltration is set between 0.5 and 1mL/kg/h when the following criteria are fulfilled: weight inferior to the admission weight; central venous pressure inferior to 5mmHg; absence of clinical oedema. The haemodynamic status is reevaluated all six hours.

after protocol implementation; before protocol implementation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult Patients in intensive care unit with acute kidney injury with continuous renal replacement therapy and fluid overload, with hemodynamic instability

You may qualify if:

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

You may not qualify if:

• \- 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."

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hôpital cardiologique Louis Pradel - HCL

Bron, France

Location

MeSH Terms

Conditions

Acute Kidney Injury; Edema

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2021
• First Posted: November 15, 2021
• Study Start: July 1, 2021
• Primary Completion: August 1, 2021
• Study Completion: September 1, 2021
• Last Updated: March 3, 2022

Record last verified: 2022-03

Locations

FR (1)