Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2023-510406-41-00 | EU Trial (CTIS) Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Current hemodialysis techniques fail to efficiently remove protein-bound uremic toxins (such as p-cresyl sulfate (p-CS) or indoxyl sulfate (IS)) due to their strong binding to serum albumin. The accumulation of these toxins in end-stage renal failure patients on hemodialysis is strongly suspected to contribute to the significant morbidity and mortality observed in this population.
Pre-clinical studies conducted previously showed that medium-chain fatty acids (such as sodium octanoate and decanoate), which are natural ligands of albumin, can effectively displace the binding of uremic toxins on serum albumin and thus promote their elimination during a hemodialysis session.
Medialipide® 20% (Braun) is an emulsion of medium chain triglycerides (MCT) (6 to 12 carbons) used in parenteral nutrition. Medialipide® constitutes a relevant clinical formulation for the administration of octanoate and decanoate because it contains 94% of sodium octanoate and decanoate.
In this study, a proof of concept intervention will be carried out to study the effect on the clearance uremic toxins clearance of the perfusion of Medialipide® emulsion (as a sodium octanoate and decanoate donor) in patients during their hemodialysis session compared to a control situation Sodium chloride (NaCl) 0,9%).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Medialipide 20% - NaCl 0,9% | Experimental | Group 1 will receive during the first interventional hemodialysis session a perfusion of Medialipide 20% perfused at a rate of 0,11 gram/kilogram/hour (g/kg/h) during 4 hours. One week late, they will receive during the second interventional hemodialysis session a perfusion of NaCl 0,9% with a volume corresponding to the one of Medialipide also during 4 hours. |
|
| NaCl 0,9% - Medialipide 20% | Experimental | Group 2 will receive during the first interventional hemodialysis session a perfusion of NaCl 0,9% with a volume corresponding to the one of Medialipide during 4 hours. One week late, they will receive during the second interventional hemodialysis session a perfusion of Medialipide 20% perfused at a rate of 0,11 gram/kilogram/hour (g/kg/h) also during 4 hours. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medialipide 20% perfusion | Drug | Each patient will receive during a 4 hours hemodialysis session a perfusion of Medialipide 20% at a rate of 0,11 g/kg/h. Medialipide will be perfused using the venous line connected to the hemodialysis machine. |
| Measure | Description | Time Frame |
|---|---|---|
| Dialytic clearance of p-CS | Dialysis clearance of p-CS (millilitre/minute) is defined as follows: Clearance = Qd X (C dialysate/C arterial) with Qd corresponding to the dialysate flow rate, C dialysate the concentration of p-CS in the dialysate, C arterial the concentration of p-CS in the blood sampled at the arterial port of the dialyser. | until 240 minutes after haemodialysis session |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction fraction (RF) of p-CS | Reduction fraction will be measured in percentage Reduction fraction will be compared between the medialipide perfusion situation and the NACL 0,9% perfusion situation. RF (%) = (Concentration of p-CS at T0 - Concentration of p-CS at T240)/Concentration of p-CS at T0 | At 240 minutes after haemodialysis session |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Residual diuresis > 100 mL per day
Pregnant or breast-feeding
Uncontrolled hypertension > 180/115 millimetre of mercury (mmHg)
Perdialytic hypotension requiring vascular filling > 100 mL during the last 3 sessions
Patients already on parenteral nutrition
Patients already on Vitamin K antagonists (VKA) (or prescribed less than one month before inclusion)
Patients with allergy to heparin or requiring haemodialysis without anticoagulant (recent haemorrhage)
Criteria relating to products/procedures: Patient with
Subject participating in another interventional study involving a drug with an exclusion period still in progress at inclusion.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fitsum GUEBRE EGZIABHER, PU,PH | Contact | 0472110260 | +33 | fitsum.guebre-egziabher@chu-lyon.fr |
| Laure-Anne RAILLON | Contact | 0633345131 | +33 | laure-anne.raillon@chu-lyon.fr |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital Edouard Herriot | Lyon | 69003 | France |
Not provided
| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D010477 | Perfusion |
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
Not provided
Not provided
Each patient will sequentially receive during two 4 hours hemodialysis session separated by one week a perfusion of Medialipide and a perfusion of NaCl 0,9%. The order of intervention will be determined by randomization.
Not provided
Not provided
Not provided
Not provided
| NaCl 0,9% | Drug | Each patient will receive during a 4 hours hemodialysis session a perfusion of NACL 0,9% with a volume corresponding to the one of Medialipide 20%. NaCl 0,9% will be perfused using the venous line connected to the hemodialysis machine. |
|
| Blood sample | Biological | Serial biological sampling for the measurement of different blood concentrations : electrolytes, serum protein , albumin, renal function (urea, creatinine), hemoglobin, hematocrit, liver test, lipid test, ketone bodies, 6 uremic toxins (including IS and p-CS), sodium octanoate and decanoate. |
|
| Dialytic clearance of Indoxyl sulfate | Dialysis clearance of Indoxyl sulfate (millilitre/minute) is defined as follows: Clearance = Qd X (C dialysate/C arterial) with Qd corresponding to the dialysate flow rate, C dialysate the concentration of Indoxyl sulfate in the dialysate, C arterial the concentration of Indoxyl sulfate in the blood sampled at the arterial port of the dialyser. | until 240 minutes after haemodialysis session |
| Reduction fraction (RF) of Indoxyl sulfate | Reduction fraction will be measured in percentage Reduction fraction will be compared between the medialipide perfusion situation and the NACL 0,9% perfusion situation. RF (%) = (Concentration of Indoxyl sulfate at T0 - Concentration of Indoxyl sulfate at T240)/Concentration of Indoxyl sulfate at T0 | At 240 minutes after haemodialysis session |
| Dialytic clearance of hippuric acid | Dialysis clearance of hippuric acid (millilitre/minute) is defined as follows: Clearance = Qd X (C dialysate/C arterial) with Qd corresponding to the dialysate flow rate, C dialysate the concentration of hippuric acid in the dialysate, C arterial the concentration of hippuric acid in the blood sampled at the arterial port of the dialyser. | until 240 minutes after haemodialysis session |
| Reduction fraction (RF) of hippuric acid | Reduction fraction will be measured in percentage Reduction fraction will be compared between the medialipide perfusion situation and the NACL 0,9% perfusion situation. RF (%) = (Concentration of hippuric acid at T0 - Concentration of hippuric acid at T240)/Concentration of hippuric acid at T0 | At 240 minutes after haemodialysis session |
| Dialytic clearance of p-cresyl glucuronide | Dialysis clearance of p-cresyl glucuronide (millilitre/minute) is defined as follows: Clearance = Qd X (C dialysate/C arterial) with Qd corresponding to the dialysate flow rate, C dialysate the concentration of p-cresyl glucuronide in the dialysate, C arterial the concentration of p-cresyl glucuronide in the blood sampled at the arterial port of the dialyser. | until 240 minutes after haemodialysis session |
| Reduction fraction (RF) of p-cresyl glucuronide | Reduction fraction will be measured in percentage Reduction fraction will be compared between the medialipide perfusion situation and the NACL 0,9% perfusion situation. RF (%) = (Concentration of p-cresyl glucuronide at T0 - Concentration of p-cresyl glucuronide at T240)/Concentration of p-cresyl glucuronide at T0 | At 240 minutes after haemodialysis session |
| Dialytic clearance of indol acetic acid | Dialysis clearance of indol acetic acid (millilitre/minute) is defined as follows: Clearance = Qd X (C dialysate/C arterial) with Qd corresponding to the dialysate flow rate, C dialysate the concentration of indol acetic acid in the dialysate, C arterial the concentration of indol acetic acid in the blood sampled at the arterial port of the dialyser. | until 240 minutes after haemodialysis session |
| Reduction fraction (RF) of indol acetic acid | Reduction fraction will be measured in percentage Reduction fraction will be compared between the medialipide perfusion situation and the NACL 0,9% perfusion situation. RF (%) = (Concentration of indol acetic acid at T0 - Concentration of indol acetic acid at T240)/Concentration of indol acetic acid at T0 | At 240 minutes after haemodialysis session |
| Dialytic clearance of uric acid | Dialysis clearance of indol acetic acid (millilitre/minute) is defined as follows: Clearance = Qd X (C dialysate/C arterial) with Qd corresponding to the dialysate flow rate, C dialysate the concentration of uric acid in the dialysate, C arterial the concentration of uric acid in the blood sampled at the arterial port of the dialyser. | until 240 minutes after haemodialysis session |
| Reduction fraction (RF) of uric acid | Reduction fraction will be measured in percentage Reduction fraction will be compared between the medialipide perfusion situation and the NACL 0,9% perfusion situation. RF (%) = (Concentration of uric acid at T0 - Concentration of uric acid at T240)/Concentration of uric acid at T0 | At 240 minutes after haemodialysis session |
| Dialytic clearance of 3-Carboxy-4-methyl-5-propyl-2-furanpropionic acid | Dialysis clearance of indol acetic acid (millilitre/minute) is defined as follows: Clearance = Qd X (C dialysate/C arterial) with Qd corresponding to the dialysate flow rate, C dialysate the concentration of 3-Carboxy-4-methyl-5-propyl-2-furanpropionic acid in the dialysate, C arterial the concentration of 3-Carboxy-4-methyl-5-propyl-2-furanpropionic acid in the blood sampled at the arterial port of the dialyser. | until 240 minutes after haemodialysis session |
| Reduction fraction (RF) of 3-Carboxy-4-methyl-5-propyl-2-furanpropionic acid | Reduction fraction will be measured in percentage Reduction fraction will be compared between the medialipide perfusion situation and the NACL 0,9% perfusion situation. RF (%) = (Concentration of 3-Carboxy-4-methyl-5-propyl-2-furanpropionic acid at T0 - Concentration of 3-Carboxy-4-methyl-5-propyl-2-furanpropionic acid at T240)/Concentration of 3-Carboxy-4-methyl-5-propyl-2-furanpropionic acid at T0 | At 240 minutes after haemodialysis session |
| Tolerance of medialipide perfusion (%) | Percentage of patients with the occurrence of at least one symptom including: nausea, emesis, headaches during the hemodialysis session | until 240 minutes after haemodialysis session |
| Safety of medialipide perfusion | % of patients who presented one of the following event : hypertriglyceridemia > 4 gram/liter, alteration of liver test (cytolysis > 2 times the normal value, cholestasis > 2 times the normal value), or hemolysis. | until 7 days after the last haemodialysis session |
| octanoate blood concentration | until 240 minutes after haemodialysis session |
| decanoate blood concentration | until 240 minutes after haemodialysis session |
| clearance of octanoate | Dialysis clearance of Indoxyl sulfate (millilitre/minute) is defined as follows: Clearance = Qd X (C dialysate/C arterial) with Qd corresponding to the dialysate flow rate, C dialysate the concentration of octanoate in the dialysate, C arterial the concentration of octanoate in the blood sampled at the arterial port of the dialyser. | until 240 minutes after haemodialysis session |
| clearance of decanoate | Dialysis clearance of Indoxyl sulfate (millilitre/minute) is defined as follows: Clearance = Qd X (C dialysate/C arterial) with Qd corresponding to the dialysate flow rate, C dialysate the concentration of decanoate in the dialysate, C arterial the concentration of decanoate in the blood sampled at the arterial port of the dialyser. | until 240 minutes after haemodialysis session |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |