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| Name | Class |
|---|---|
| CHU de Lille | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Other | Using acetate-based dialysate |
|
| Experimental group | Experimental | Using citrate-based dialysate |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACETATE based dialysate | Device | Intermittent hemodialysis with an acetate based dialysate. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| 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; | day 28 |
| Compare between the two groups (acetate- vs citrate-based dialysate) the length of stay in Intensive Care Unit. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Martin GÉRARD | Contact | 03.21.64.44.44 | mgerard@ch-bethune.fr | |
| Christophe VINSONNEAU | Contact | 03.21.64.44.44 | cvinsonneau@ch-bethune.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Béthune | Recruiting | Béthune | 62408 | France |
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| CITRATE based dialysate | Device | Intermittent hemodialysis with an citrate based dialysate. |
|
Length of stay in Intensive Care Unit |
| day 28 |
| Compare between the two groups (acetate- vs citrate-based dialysate) the Length of stay in hospital. | Length of stay in hospital; | day 28 |
| 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 | day 28 |
| Compare between the two groups (acetate- vs citrate-based dialysate) the dialysis dependency at discharge from ICU and hospital. | Dialysis dependency at discharge from ICU and hospital. | day 28 |
| Compare between the two groups (acetate- vs citrate-based dialysate) the time to recovery of diuresis > 0.5ml/kg/h. | Time to recovery of diuresis > 0.5ml/kg/h | day 28 |
| Compare between the two groups (acetate- vs citrate-based dialysate) the change in SOFA score between D0 and D7. | Change in SOFA score between D0 and D7 | day 28 |
| Compare between the two groups (acetate- vs citrate-based dialysate) the number of days without catecholamine. | Number of days without catecholamine | day 28 |
| Compare between the two groups (acetate- vs citrate-based dialysate) the number of days without mechanical ventilation. | Number of days without mechanical ventilation. | day 28 |
| Compare between the two groups (acetate- vs citrate-based dialysate) the ratio of Kt/V (achieved/prescribed). | The ratio of Kt/V (achieved/prescribed) | day 28 |
| Compare between the two groups (acetate- vs citrate-based dialysate) session duration ratio (duration achieved/prescribed). | Difference between session duration achieved and prescribed | day 28 |
| Compare between the two groups (acetate- vs citrate-based dialysate) UF ratio (UF prescribed/realized) | UF ratio (UF prescribed/realized) | day 28 |
| Compare between the two groups (acetate- vs citrate-based dialysate) urea reduction rate (pre-dialysis urea - post-dialysis urea/pre-dialysis urea) | Urea reduction rate (pre-dialysis urea - post-dialysis urea/pre-dialysis urea) | day 28 |
| Compare between the two groups (acetate- vs citrate-based dialysate) average, maximum and end-of-session blood and dialysate flow rates. | Average, maximum and end-of-session blood and dialysate flow rates. | day 28 |
| Compare between the two groups (acetate- vs citrate-based dialysate) the pre-post dialysis variation in creatinine levels. | The pre-post dialysis variation in creatinine levels | day 28 |
| Compare between the two groups (acetate- vs citrate-based dialysate) the pre-post dialysis variation of pH and bicarbonate level. | The pre-post dialysis variation of pH and bicarbonate level | day 28 |
| Compare between the two groups (acetate- vs citrate-based dialysate) the pre-post dialysis variation in kalemia. | The pre-post dialysis variation in kalemia | day 28 |
| Compare between the two groups (acetate- vs citrate-based dialysate) the pre-post dialysis the rate variation of sodium, magnesium and calcium. | The pre-post dialysis rate variation of sodium, magnesium and calcium | day 28 |
| Compare between the two groups (acetate- vs citrate-based dialysate) the rate of calcium supplemented between two IHD sessions. | The rate of calcium supplemented between two IHD sessions. | day 28 |
| Evaluate the hemodynamic tolerance | according to the randomization groups : the response to the passive leg raising, respiratory variation of the inferior vena cava etc... | Each dialysis until day 28 |
| CHU | Recruiting | Caen | France |
|
| Centre Hospitalier Universitaire de Dijon | Recruiting | Dijon | France |
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| CHRU Nancy | Recruiting | Nancy | France |
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| CHU de ROUEN | Not yet recruiting | Rouen | 59507 | France |
|
| ID | Term |
|---|---|
| D007022 | Hypotension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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