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Completed

NCT Number: NCT06071026

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Universitaire de Nîmes

Nîmes, France

About this study

Renal renal replacement therapy (RRT) for severe acute kidney injury is one of the most widely used life-support techniques in intensive care. One of its main functions is to maintain the water balance in oligo-anuric patients by means of net ultrafiltration (NUF), defined as the volume of water removed from the patient by the RRT per unit time and indexed to the patient's weight.

Surprisingly, the setting of this parameter, which is one of the most important, there are no guidelines. If net ultrafiltration is too low, it may prolong RRT dependency and length of stay in the ICU, with all the associated care-related complications, and increase mortality. If net ultrafiltration is too high, it may transiently induce hypovolemia, leading to hemodynamic instability related to renal replacement therapy (HIRRT).

A recent survey of French practices shows that the average NUF flow rate used in intensive care units in France is 119 ± 77 ml/h, and the median flow rate is 100 ml/h [min-max 20-300]; in this study, NUF was not indexed by weight, but for a patient with an average weight of 75 kg, corresponding to an average NUF of 1.6 ± 1 ml/kg/h.

In the NEPTUNE study, the investigators aim to compare the hemodynamic effect of three net ultrafiltration rates during RRT: 1 ml/kg/h, 2 ml/kg/h and 3 ml/kg/h. These three flow rates are within the range of those usually used in clinical practice.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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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 in exclusion period determined by another 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.

Treatment and study plan

Net Ultra Filtration Rate

Device

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

Primary outcomes

  1. Occurrence of HIRRT

    Time frame: 6 hours

    Occurrence of Hemodynamic Instability related to Renal Replacement Therapy

Secondary outcomes

  1. Number of HIRRT

    Time frame: 6 hours

    Number of HIRRT episodes in 6-hour sessions, i.e. number of hypotensive episodes during the 6-hour UFN cycle with mean arterial pressure < 65 mmHg [n]

  2. Water depletion

    Time frame: 6 hours

    Total volume of water depleted during 6-hour session [ml/kg/6h]

  3. Fluid intake

    Time frame: 6 hours

    The volume of all fluid intake (resuscitative fluids, transfusions of blood derivatives) during the 6-hour session [ml/kg/6h].

  4. Time before HIRRT in each session

    Time frame: 6 hours

    Time in hours between start of session and onset of hemodynamic instability (h)

  5. Time between start of RRT and HIRRT

    Time frame: 28 days

    Time in hours between start of RRT and onset of hemodynamic instability (h)

  6. Atrial fibrillation

    Time frame: 28 days

    Proportion of sessions with onset of atrial fibrillation (%)

  7. Variation in norepinephrine

    Time frame: 6 hours

    • variation between h0 and h6 in norepinephrine dosage [µg/kg/min].
  8. Variations in central venous pressure

    Time frame: 6 hours

    Variations between h0 and h6 in central venous pressure (CVP) [mmHg].

  9. Variations in heart rate

    Time frame: 6 hours

    Variations between h0 and h6 in heart rate [bpm].

  10. Variations in arterial pressure

    Time frame: 6 hours

    Variations between h0 and h6 in systolic, diastolic and mean arterial pressure (MAP) [mmHg].

  11. Slope of arterial pressure

    Time frame: 6 hours

    Slope of variation in systolic, diastolic and mean arterial pressure between h0 and h6 obtained with repeated hourly measurements

  12. Frequency of episodes of arterial hypertension

    Time frame: 6 hours

    Frequency of episodes between h0 and h6 of arterial hypertension defined by a systolic blood pressure greater than 180 mmHg [n].

  13. Variations in arterial lactate levels

    Time frame: 6 hours

    Variations between h0 and h6 in arterial lactate levels [mmol/l].

  14. Variations in central venous oxygen saturation (SvcO2)

    Time frame: 6 hours

    Variations between h0 and h6 in central venous oxygen saturation (SvcO2) measured in the superior vena cava [%].

  15. Variations in hematocrit

    Time frame: 6 hours

    Variations between h0 and h6 in hematocrit [%].

  16. Variations in albuminemia

    Time frame: 6 hours

    Variations between h0 and h6 in albuminemia [g/L].

  17. Variations in natremia

    Time frame: 6 hours

    Variations in natremia [mmol/L] between h0 and h6

  18. Frequency of mottling

    Time frame: 6 hours

    Frequency of clinical signs/symptoms potentially associated with per-dialytic hypotension during the session: mottling. [n]

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Official study title

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.

Acronym: NEPTUNE

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Oct 6, 2023
Registry last updated
Nov 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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