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

Acute Kidney Injury Clinical Trial

— Early Dry  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05119361
• Other study ID #: 454
• Status: Completed
• Start date: July 1, 2021
• Est. completion date: September 1, 2021

Study information

• Verified date: March 2022
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: September 1, 2021
• Est. primary completion date: August 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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."

Related Conditions & MeSH terms

• Acute Kidney Injury

Intervention

Other:
• Early 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.

Locations

Country	Name	City	State
France	Hôpital cardiologique Louis Pradel - HCL	Bron

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.