Intradialytic Hypotension
Conditions
Keywords
citrate based dialysate, acetate based dialysate, hypotension, hemodynamic tolerance
Brief summary
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.
Interventions
DEVICEACETATE based dialysate
Intermittent hemodialysis with an acetate based dialysate.
DEVICECITRATE based dialysate
Intermittent hemodialysis with an citrate based dialysate.
Sponsors
Centre Hospitalier de Bethune
CHU de Lille
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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) * Indication for Extra Renal Replacement Therapy with IHD.
Exclusion criteria
* Pregnant or breastfeeding woman * Known chronic renal insufficiency of any stage * Cardio-renal and hepato renal syndrome * Unstable hemodynamic state: refractory shock * Patient included in another interventional study likely to modify the hemodynamic state * Patient deprived of liberty * Patient under guardianship or curatorship * Patient not affiliated to a social security system
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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)). | day 28 | The rate of sessions with occurence of at least one IHI. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Compare between the two groups (acetate- vs citrate-based dialysate) the mortality at day 28 and in ICU; | day 28 | Mortality at day 28 and in ICU; |
| Compare between the two groups (acetate- vs citrate-based dialysate) the length of stay in Intensive Care Unit. | day 28 | Length of stay in Intensive Care Unit |
| Compare between the two groups (acetate- vs citrate-based dialysate) the Length of stay in hospital. | day 28 | Length of stay in hospital; |
| Compare between the two groups (acetate- vs citrate-based dialysate) the Number of days without dialysis in Intensive Care Unit. | day 28 | Number of days without dialysis in Intensive Care Unit |
| Compare between the two groups (acetate- vs citrate-based dialysate) the dialysis dependency at discharge from ICU and hospital. | day 28 | Dialysis dependency at discharge from ICU and hospital. |
| Compare between the two groups (acetate- vs citrate-based dialysate) the time to recovery of diuresis > 0.5ml/kg/h. | day 28 | Time to recovery of diuresis \> 0.5ml/kg/h |
| Compare between the two groups (acetate- vs citrate-based dialysate) the change in SOFA score between D0 and D7. | day 28 | Change in SOFA score between D0 and D7 |
| Compare between the two groups (acetate- vs citrate-based dialysate) the number of days without catecholamine. | day 28 | Number of days without catecholamine |
| Compare between the two groups (acetate- vs citrate-based dialysate) the number of days without mechanical ventilation. | day 28 | Number of days without mechanical ventilation. |
| Compare between the two groups (acetate- vs citrate-based dialysate) the ratio of Kt/V (achieved/prescribed). | day 28 | The ratio of Kt/V (achieved/prescribed) |
| Compare between the two groups (acetate- vs citrate-based dialysate) session duration ratio (duration achieved/prescribed). | day 28 | Difference between session duration achieved and prescribed |
| Compare between the two groups (acetate- vs citrate-based dialysate) UF ratio (UF prescribed/realized) | day 28 | UF ratio (UF prescribed/realized) |
| Compare between the two groups (acetate- vs citrate-based dialysate) urea reduction rate (pre-dialysis urea - post-dialysis urea/pre-dialysis urea) | day 28 | Urea reduction rate (pre-dialysis urea - post-dialysis urea/pre-dialysis urea) |
| Compare between the two groups (acetate- vs citrate-based dialysate) average, maximum and end-of-session blood and dialysate flow rates. | day 28 | Average, maximum and end-of-session blood and dialysate flow rates. |
| Compare between the two groups (acetate- vs citrate-based dialysate) the pre-post dialysis variation in creatinine levels. | day 28 | The pre-post dialysis variation in creatinine levels |
| Compare between the two groups (acetate- vs citrate-based dialysate) the pre-post dialysis variation of pH and bicarbonate level. | day 28 | The pre-post dialysis variation of pH and bicarbonate level |
| Compare between the two groups (acetate- vs citrate-based dialysate) the pre-post dialysis variation in kalemia. | day 28 | The pre-post dialysis variation in kalemia |
| Compare between the two groups (acetate- vs citrate-based dialysate) the pre-post dialysis the rate variation of sodium, magnesium and calcium. | day 28 | The pre-post dialysis rate variation of sodium, magnesium and calcium |
| Compare between the two groups (acetate- vs citrate-based dialysate) the rate of calcium supplemented between two IHD sessions. | day 28 | The rate of calcium supplemented between two IHD sessions. |
| Evaluate the hemodynamic tolerance | Each dialysis until day 28 | according to the randomization groups : the response to the passive leg raising, respiratory variation of the inferior vena cava etc... |
Countries
France
Contacts
CONTACTMartin GÉRARD
CONTACTChristophe VINSONNEAU
Outcome results
None listed