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

Sponsor
Hospices Civils de Lyon (Other)
Overall Status
Completed
CT.gov ID
NCT05119361
Collaborator
(none)
100
1
2
49.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Early Dry protocol

Study Design

Study Type:
Observational
Actual Enrollment :
100 participants
Observational Model:
Cohort
Time Perspective:
Prospective
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.
Actual Study Start Date :
Jul 1, 2021
Actual Primary Completion Date :
Aug 1, 2021
Actual Study Completion Date :
Sep 1, 2021

Arms and Interventions

Arm Intervention/Treatment
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 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

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

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.

Outcome Measures

Primary Outcome Measures

  1. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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."

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hôpital cardiologique Louis Pradel - HCL Bron France

Sponsors and Collaborators

  • Hospices Civils de Lyon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT05119361
Other Study ID Numbers:
  • 454
First Posted:
Nov 15, 2021
Last Update Posted:
Mar 3, 2022
Last Verified:
Mar 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Hospices Civils de Lyon
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 3, 2022