Improved Hemodynamic Tolerance of Intermittent Hemodialysis Sessions in Intensive Care Unite Using Citrate- vs Acetate-based Dialysate

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Hospitalier de Bethune

About this trial

During intermittent hemodialysis (IHD), the occurrence of intradialytic hemodynamic instability (IHI) is frequent in ICU and impacted morbidity and mortality. Bicarbonate dialysate buffer improves hemodynamic tolerance compared to acetate dialysate buffer. However, bicarbonate dialysate buffer still contains a lower concentration of acetate, which could contribute to hemodynamic instability. Recently, citrate-based dialysate in bicarbonate hemodialysis instead of acetate have been proposed. They have the appropriate authorizations for routine use. The aim of this study is to compare acetate- vs citrate-based dialysate in terms of hemodynamic tolerance and effectiveness.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patient ≥ 18 years old

Patient hospitalized in an intensive care unit

Patient with acute renal failure defined by a KDIGO stage ≥ 1 and suspected non-obstructive

Patient at risk of per dialytic hypotension (capillary refill time ≥ 3 seconds and/or cardiovascular SOFA ≥ 1 and/or lactatemia > 2mmol/L)

Disqualifiers

Pregnant or breastfeeding woman

Known chronic renal insufficiency of any stage

Cardio-renal and hepato renal syndrome

Unstable hemodynamic state: refractory shock

Trial design

Design model

Parallel

Treatments tested in this trial

  • ACETATE based dialysate

    Device

    Intermittent hemodialysis with an acetate based dialysate.

  • CITRATE based dialysate

    Device

    Intermittent hemodialysis with an citrate based dialysate.

Treatment groups

48 Participants
are divided into 2 treatment groups
Group A: Control groupOther 1 intervention
Group B: Experimental groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

To show that the use of a citrate-based dialysate decreases the occurrence of intradialytic hypotension in the ICU compared with an acetate-based dialysate (The rate of sessions with occurence of at least one hemodynamic instability (IHI)).

The rate of sessions with occurence of at least one IHI.

Time frame
day 28

Secondary outcomes

1

Compare between the two groups (acetate- vs citrate-based dialysate) the mortality at day 28 and in ICU;

Mortality at day 28 and in ICU;

Time frame
day 28
2

Compare between the two groups (acetate- vs citrate-based dialysate) the length of stay in Intensive Care Unit.

Length of stay in Intensive Care Unit

Time frame
day 28
3

Compare between the two groups (acetate- vs citrate-based dialysate) the Length of stay in hospital.

Length of stay in hospital;

Time frame
day 28
4

Compare between the two groups (acetate- vs citrate-based dialysate) the Number of days without dialysis in Intensive Care Unit.

Number of days without dialysis in Intensive Care Unit

Time frame
day 28

Other outcomes

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