Effects of Variation of Sodium Dialysate in ICU

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversity Hospital, Montpellier

About this trial

Intermittent hemodialysis/diafiltration is a current renal replacement therapy (RRT) institued for ICU patients with AKI. For a better clinical tolerance, iinternational guidelines advise to use cold dialysate, increase duration session, decrease blood and dialysate flows, and increase level of sodium dialysate concentration (≥ 145mmol/l). Indeed, the use of a Na concentration dialysate \> 145 mmol/l improves intradialytic hemodynamic tolerance but it may also induce fluid overload by the transfert of sodium from the dialysate compartment to the blood. Yet, fluid overload has been strongly associated with mortality in critically ills. The investigators hypothesized that the use of a level in sodium dialysate at 140 mmol/l with slow low efficiency daily dialysis-filtration (SLEDD-f) will permit a fair intradialytic hemodynamic tolerance without the adverse effect of intradiaclytic Na loading from the dialysate. Two randomized groups of ICU AKI patients treated by SLEDD-f will be compared in terms of intradialytic hemodynamic tolerance and overload accordong to 140 or 145 mmol/l of Na in the dialysate

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age > 18 years old

Acute kidney injury requiring renal replacement therapy

Dialysis type: on line sustained low efficiency dialy dialysis -filtration

SOFA score > 5

Disqualifiers

Chronic kidney disease stade IV ou V

Obstrutive acute kidney injury

Renal tansplantation in the year before ICU admission

Moribund with risk of death in the 48 hours

Trial design

Design model

Parallel

Treatments tested in this trial

  • Lowering sodium concentration dialysate

    Drug

    Concentration of sodium in dialysate at 140 mmol/l

  • Highing sodium concentration dialysate

    Drug

    Concentration of sodium in dialysate at 145 mmol/l

Treatment groups

158 Participants
are divided into 2 treatment groups
Group A: Low sodium concentrationActive comparator 1 intervention
Group B: High Sodium ConcentrationSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Fluid overload

Daily weight measure from the initiation to the weaning of RRT. Daily monitoring of inpout and output.

Time frame
7 days after the initiation of renal replacement therapy
2

Fluid overload

Daily weight measure from the initiation to the weaning of RRT.

Time frame
day 28

Secondary outcomes

1

Intradialytic hemodynamic tolerance

Intradialytic hemodynamic tolerance

Time frame
during the requiring renal replacement therapy (RRT)
2

Mean ultrafiltration rate by patient/ session

Appreciation of ultrafiltration rate for each patient and for each RRT session for all the renal replacement therapy. Calcultate the mean ultrafiltration rate by patient. Daily Weight measurement before and after each RRT session and daily

Time frame
1 day
3

Fluid overload

Fluid overload after RRT weaning and ICU stay.

Time frame
1 day
4

Total duration of RRT

Total duration of RRT at end of hospitalization

Time frame
1 day

Other outcomes

Sponsors and contacts

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