Evaluation of the Hemodynamic Effect of Variations in Net Ultrafiltration Rate During Continuous Renal Replacement Therapy Sessions for Acute Renal Failure in Intensive Care Patients. Multiple N-of-1 Randomised Bi-centric Controlled Trial.

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Net ultra filtration (NUF) is one of the most important parameters during renal replacement therapy (RRT) whose role is to control fluid balance by water removal. To our knowledge, there are no prospective studies or guidelines about the setting of this parameter. In the NEPTUNE study, we aim to compare the hemodynamic effect of three NUF rates during RRT: 1 ml/kg/h, 2 ml/kg/h and 3 ml/kg/h. The research hypothesis is that one of the three flow rates evaluated induces the fewest hemodynamic instabilities related to RRT, while guaranteeing the best possible fluid balance.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patients hospitalised in the intensive care unit of one of the two participating centres

• Patients with Kidney Disease: Improving Global Outcomes 3 (KDIGO3) acute kidney injury (AKI) requiring a continuous RRT during their stay in the intensive care unit, regardless of the aetiology of the AKI

• Need to prescribe water loss by net ultrafiltration (NUF), defined by at least one of the following sub-criteria:

‣ weight gain ≥ 1 kg relative to entry weight

⁃ oligo-anuria ≥ 24 hours

⁃ clinical impact of fluid overload as judged by the clinician: acute lung oedema clinical or at CT-scan, difficulty of weaning from mechanical ventilation.

• Hemodynamic stability in the 2 hours preceding the start of NUF, defined by all of the following sub-criteria:

‣ absence of vasopressors (noradrenaline) or stability or reduction in their dosage

⁃ no need for resuscitative fluids as judged by the clinician

• Patient or his/her trusted support person/legal representative/family member having given free and informed consent, and having signed the consent form or patient included in an emergency situation.

• Patient affiliated to or benefiting from a health insurance scheme.

Locations
Other Locations
France
Centre Hospitalier Universitaire de Nîmes
RECRUITING
Nîmes
Contact Information
Primary
Saber D. BARBAR, MD, PhD
saber.barbar@chu-nimes.fr
0033 4 66 68 33 20
Backup
Jean-Yves LEFRANT, MD, PhD
jean-yves.lefrant@chu-nimes.fr
0033 4 66 68 33 20
Time Frame
Start Date: 2023-10-06
Estimated Completion Date: 2025-12-21
Participants
Target number of participants: 39
Treatments
Experimental: 1 ml/kg/h
Net ultra filtration setting: 1 ml/kg/h
Experimental: 2 ml/kg/h
Net ultra filtration setting: 2 ml/kg/h
Experimental: 3 ml/kg/h
Net ultra filtration setting: 3 ml/kg/h
Related Therapeutic Areas
Sponsors
Leads: Centre Hospitalier Universitaire de Nīmes

This content was sourced from clinicaltrials.gov