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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital cardiologique Louis Pradel - HCL

Bron, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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."

Treatment and study plan

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.

Primary outcomes

Computed cumulative fluid balance (mL) at day 5 after protocol onset.

Time frame: 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

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Acronym: Early Dry

Important dates

Study start: 2021
Primary completion: 2021
Study completion: 2021
First posted: Nov 15, 2021
Registry last updated: Mar 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed