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

Impact on the Fluid Balance of a Perfusion Based Protocol to Adjust UFnet During Deresuscitation in Intensive Care Unit. A Before-after Study.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05119361
Acronym
Early Dry
Enrollment
100
Registered
2021-11-15
Start date
2021-07-01
Completion date
2021-09-01
Last updated
2022-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Kidney Injury

Keywords

ultrafiltration, deresuscitation, fluid overload, fluid balance.

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.

Interventions

OTHEREarly Dry protocol

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.

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frameDescription
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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026