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

Primary Purpose

Intradialytic Hypotension

Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
ACETATE based dialysate
CITRATE based dialysate
Sponsored by
Centre Hospitalier de Bethune
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Intradialytic Hypotension focused on measuring citrate based dialysate, acetate based dialysate, hypotension, hemodynamic tolerance

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 > 2) 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

Sites / Locations

  • Centre Hospitalier Béthune
  • Centre Hospitalier Universitaire de Caen

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Control group

Experimental group

Arm Description

Using acetate-based dialysate

Using citrate-based dialysate

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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;
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
Compare between the two groups (acetate- vs citrate-based dialysate) the Length of stay in hospital.
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.
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.
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.
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.
Change in SOFA score between D0 and D7
Compare between the two groups (acetate- vs citrate-based dialysate) the number of days without catecholamine.
Number of days without catecholamine
Compare between the two groups (acetate- vs citrate-based dialysate) the number of days without mechanical ventilation.
Number of days without mechanical ventilation.
Compare between the two groups (acetate- vs citrate-based dialysate) the ratio of Kt/V (achieved/prescribed).
The ratio of Kt/V (achieved/prescribed)
Compare between the two groups (acetate- vs citrate-based dialysate) session duration ratio (duration achieved/prescribed).
Difference between session duration achieved and prescribed
Compare between the two groups (acetate- vs citrate-based dialysate) UF ratio (UF prescribed/realized)
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)
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.
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.
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.
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.
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.
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.
The rate of calcium supplemented between two IHD sessions.
Evaluate the hemodynamic tolerance
according to the randomization groups : the response to the passive leg raising, respiratory variation of the inferior vena cava etc...

Full Information

First Posted
May 19, 2023
Last Updated
June 29, 2023
Sponsor
Centre Hospitalier de Bethune
Collaborators
CHU de Lille
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1. Study Identification

Unique Protocol Identification Number
NCT05936710
Brief Title
Improved Hemodynamic Tolerance of Intermittent Hemodialysis Sessions in Intensive Care Unite Using Citrate- vs Acetate-based Dialysate
Acronym
HEMODIACIDE
Official Title
Improved Hemodynamic Tolerance of Intermittent Hemodialysis Sessions in Intensive Care Unite (ICU) Using Citrate- vs Acetate-based Dialysate
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 1, 2023 (Anticipated)
Primary Completion Date
July 29, 2024 (Anticipated)
Study Completion Date
September 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier de Bethune
Collaborators
CHU de Lille

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intradialytic Hypotension
Keywords
citrate based dialysate, acetate based dialysate, hypotension, hemodynamic tolerance

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Other
Arm Description
Using acetate-based dialysate
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Using citrate-based dialysate
Intervention Type
Device
Intervention Name(s)
ACETATE based dialysate
Intervention Description
Intermittent hemodialysis with an acetate based dialysate.
Intervention Type
Device
Intervention Name(s)
CITRATE based dialysate
Intervention Description
Intermittent hemodialysis with an citrate based dialysate.
Primary Outcome Measure Information:
Title
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)).
Description
The rate of sessions with occurence of at least one IHI.
Time Frame
day 28
Secondary Outcome Measure Information:
Title
Compare between the two groups (acetate- vs citrate-based dialysate) the mortality at day 28 and in ICU;
Description
Mortality at day 28 and in ICU;
Time Frame
day 28
Title
Compare between the two groups (acetate- vs citrate-based dialysate) the length of stay in Intensive Care Unit.
Description
Length of stay in Intensive Care Unit
Time Frame
day 28
Title
Compare between the two groups (acetate- vs citrate-based dialysate) the Length of stay in hospital.
Description
Length of stay in hospital;
Time Frame
day 28
Title
Compare between the two groups (acetate- vs citrate-based dialysate) the Number of days without dialysis in Intensive Care Unit.
Description
Number of days without dialysis in Intensive Care Unit
Time Frame
day 28
Title
Compare between the two groups (acetate- vs citrate-based dialysate) the dialysis dependency at discharge from ICU and hospital.
Description
Dialysis dependency at discharge from ICU and hospital.
Time Frame
day 28
Title
Compare between the two groups (acetate- vs citrate-based dialysate) the time to recovery of diuresis > 0.5ml/kg/h.
Description
Time to recovery of diuresis > 0.5ml/kg/h
Time Frame
day 28
Title
Compare between the two groups (acetate- vs citrate-based dialysate) the change in SOFA score between D0 and D7.
Description
Change in SOFA score between D0 and D7
Time Frame
day 28
Title
Compare between the two groups (acetate- vs citrate-based dialysate) the number of days without catecholamine.
Description
Number of days without catecholamine
Time Frame
day 28
Title
Compare between the two groups (acetate- vs citrate-based dialysate) the number of days without mechanical ventilation.
Description
Number of days without mechanical ventilation.
Time Frame
day 28
Title
Compare between the two groups (acetate- vs citrate-based dialysate) the ratio of Kt/V (achieved/prescribed).
Description
The ratio of Kt/V (achieved/prescribed)
Time Frame
day 28
Title
Compare between the two groups (acetate- vs citrate-based dialysate) session duration ratio (duration achieved/prescribed).
Description
Difference between session duration achieved and prescribed
Time Frame
day 28
Title
Compare between the two groups (acetate- vs citrate-based dialysate) UF ratio (UF prescribed/realized)
Description
UF ratio (UF prescribed/realized)
Time Frame
day 28
Title
Compare between the two groups (acetate- vs citrate-based dialysate) urea reduction rate (pre-dialysis urea - post-dialysis urea/pre-dialysis urea)
Description
Urea reduction rate (pre-dialysis urea - post-dialysis urea/pre-dialysis urea)
Time Frame
day 28
Title
Compare between the two groups (acetate- vs citrate-based dialysate) average, maximum and end-of-session blood and dialysate flow rates.
Description
Average, maximum and end-of-session blood and dialysate flow rates.
Time Frame
day 28
Title
Compare between the two groups (acetate- vs citrate-based dialysate) the pre-post dialysis variation in creatinine levels.
Description
The pre-post dialysis variation in creatinine levels
Time Frame
day 28
Title
Compare between the two groups (acetate- vs citrate-based dialysate) the pre-post dialysis variation of pH and bicarbonate level.
Description
The pre-post dialysis variation of pH and bicarbonate level
Time Frame
day 28
Title
Compare between the two groups (acetate- vs citrate-based dialysate) the pre-post dialysis variation in kalemia.
Description
The pre-post dialysis variation in kalemia
Time Frame
day 28
Title
Compare between the two groups (acetate- vs citrate-based dialysate) the pre-post dialysis the rate variation of sodium, magnesium and calcium.
Description
The pre-post dialysis rate variation of sodium, magnesium and calcium
Time Frame
day 28
Title
Compare between the two groups (acetate- vs citrate-based dialysate) the rate of calcium supplemented between two IHD sessions.
Description
The rate of calcium supplemented between two IHD sessions.
Time Frame
day 28
Title
Evaluate the hemodynamic tolerance
Description
according to the randomization groups : the response to the passive leg raising, respiratory variation of the inferior vena cava etc...
Time Frame
Each dialysis until day 28

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 > 2) 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Martin GÉRARD
Phone
03.21.64.44.44
Email
mgerard@ch-bethune.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Christophe VINSONNEAU
Phone
03.21.64.44.44
Email
cvinsonneau@ch-bethune.fr
Facility Information:
Facility Name
Centre Hospitalier Béthune
City
Béthune
ZIP/Postal Code
62408
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
MELANIE VERLAY
Phone
0321691028
Email
mverlay@ch-lens.fr
First Name & Middle Initial & Last Name & Degree
Martin GÉRARD
First Name & Middle Initial & Last Name & Degree
Christophe VINSONNEAU
Facility Name
Centre Hospitalier Universitaire de Caen
City
Caen
ZIP/Postal Code
14000
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Damien DU CHEYRON

12. IPD Sharing Statement

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

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