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

NCT ID: NCT05119361

Last Updated: 2022-03-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-07-01
• Study Completion Date: 2021-09-01

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Early Dry protocol

Intervention Type: 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

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

Early Dry protocol

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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."

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hôpital cardiologique Louis Pradel - HCL

Bron, , France

Countries

France

Other Identifiers

454

Identifier Type: -

Identifier Source: org_study_id