Hemodynamic Effects of Variations in Net Ultrafiltration Rate During Continuous Renal Replacement Therapy.

NCT06071026 | Completed

• 1 other identifier: NIMAO/2022-2/SDB-01
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Fluid Overload; Hemodynamic Instability

Keywords

fluid overload; renal replacement therapy; hemodynamic instability; acute kidney injury

Outcome Measures

Primary Outcomes (1)

• Occurrence of HIRRT

  Occurrence of Hemodynamic Instability related to Renal Replacement Therapy

  6 hours

Secondary Outcomes (18)

• Number of HIRRT

  6 hours

• Water depletion

  6 hours

• Fluid intake

  6 hours

• Time before HIRRT in each session

  6 hours

• Time between start of RRT and HIRRT

  28 days

Study Arms (3)

1 ml/kg/h

EXPERIMENTAL

Net ultra filtration setting: 1 ml/kg/h

Device: Net Ultra Filtration Rate

2 ml/kg/h

EXPERIMENTAL

Net ultra filtration setting: 2 ml/kg/h

Device: Net Ultra Filtration Rate

3 ml/kg/h

EXPERIMENTAL

Net ultra filtration setting: 3 ml/kg/h

Device: Net Ultra Filtration Rate

Interventions

Net Ultra Filtration Rate DEVICE

The net ultra filtration rate is modified every 6 hours accordingly to randomisation

1 ml/kg/h; 2 ml/kg/h; 3 ml/kg/h

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patient moribund, with life expectancy too low to benefit from treatment, or with decision to discontinue treatment
• Patient participating in an another interventional study
• Patient under court protection or guardianship
• Patient/trusted person/legal representative/family member for whom it is impossible to give informed information.
• Pregnant, parturient or breast-feeding patient.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

Centre Hospitalier Universitaire de Nîmes

Nîmes, France

Location

Related Publications (4)

• Hoste EA, Bagshaw SM, Bellomo R, Cely CM, Colman R, Cruz DN, Edipidis K, Forni LG, Gomersall CD, Govil D, Honore PM, Joannes-Boyau O, Joannidis M, Korhonen AM, Lavrentieva A, Mehta RL, Palevsky P, Roessler E, Ronco C, Uchino S, Vazquez JA, Vidal Andrade E, Webb S, Kellum JA. Epidemiology of acute kidney injury in critically ill patients: the multinational AKI-EPI study. Intensive Care Med. 2015 Aug;41(8):1411-23. doi: 10.1007/s00134-015-3934-7. Epub 2015 Jul 11.

  PMID: 26162677 BACKGROUND

• Murugan R, Balakumar V, Kerti SJ, Priyanka P, Chang CH, Clermont G, Bellomo R, Palevsky PM, Kellum JA. Net ultrafiltration intensity and mortality in critically ill patients with fluid overload. Crit Care. 2018 Sep 24;22(1):223. doi: 10.1186/s13054-018-2163-1.

  PMID: 30244678 BACKGROUND

• Sharma S, Waikar SS. Intradialytic hypotension in acute kidney injury requiring renal replacement therapy. Semin Dial. 2017 Nov;30(6):553-558. doi: 10.1111/sdi.12630. Epub 2017 Jun 30.

  PMID: 28666082 BACKGROUND

• Murugan R, Kerti SJ, Chang CH, Gallagher M, Neto AS, Clermont G, Ronco C, Palevsky PM, Kellum JA, Bellomo R. Association between Net Ultrafiltration Rate and Renal Recovery among Critically Ill Adults with Acute Kidney Injury Receiving Continuous Renal Replacement Therapy: An Observational Cohort Study. Blood Purif. 2022;51(5):397-409. doi: 10.1159/000517281. Epub 2021 Jul 21.

  PMID: 34289471 BACKGROUND

MeSH Terms

Conditions

Edema; Acute Kidney Injury

Condition Hierarchy (Ancestors)

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

Study Officials

• Saber D. BARBAR, MD, PhD

  Centre Hospitalier Universitaire de Nīmes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Multiple N of one trial

Study Record Dates

• First Submitted: September 19, 2023
• First Posted: October 6, 2023
• Study Start: October 6, 2023
• Primary Completion: July 8, 2025
• Study Completion: July 8, 2025
• Last Updated: November 17, 2025

Record last verified: 2025-07

Locations

FR (1)