Centre Hospitalier Universitaire de Nîmes
Nîmes, France
NCT Number: NCT06071026
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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All sexes
Interventional
Not applicable
Nîmes, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The net ultra filtration rate is modified every 6 hours accordingly to randomisation
Time frame: 6 hours
Occurrence of Hemodynamic Instability related to Renal Replacement Therapy
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]
Time frame: 6 hours
Total volume of water depleted during 6-hour session [ml/kg/6h]
Time frame: 6 hours
The volume of all fluid intake (resuscitative fluids, transfusions of blood derivatives) during the 6-hour session [ml/kg/6h].
Time frame: 6 hours
Time in hours between start of session and onset of hemodynamic instability (h)
Time frame: 28 days
Time in hours between start of RRT and onset of hemodynamic instability (h)
Time frame: 28 days
Proportion of sessions with onset of atrial fibrillation (%)
Time frame: 6 hours
Time frame: 6 hours
Variations between h0 and h6 in central venous pressure (CVP) [mmHg].
Time frame: 6 hours
Variations between h0 and h6 in heart rate [bpm].
Time frame: 6 hours
Variations between h0 and h6 in systolic, diastolic and mean arterial pressure (MAP) [mmHg].
Time frame: 6 hours
Slope of variation in systolic, diastolic and mean arterial pressure between h0 and h6 obtained with repeated hourly measurements
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].
Time frame: 6 hours
Variations between h0 and h6 in arterial lactate levels [mmol/l].
Time frame: 6 hours
Variations between h0 and h6 in central venous oxygen saturation (SvcO2) measured in the superior vena cava [%].
Time frame: 6 hours
Variations between h0 and h6 in hematocrit [%].
Time frame: 6 hours
Variations between h0 and h6 in albuminemia [g/L].
Time frame: 6 hours
Variations in natremia [mmol/L] between h0 and h6
Time frame: 6 hours
Frequency of clinical signs/symptoms potentially associated with per-dialytic hypotension during the session: mottling. [n]
Centre Hospitalier Universitaire de Nīmes
Other
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
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