Conventional Hemodialysis Versus Post-Dilution Hemofiltration in Incident RRT (DA-VINCI)
A Pilot Randomized Control Trial of Conventional Hemodialysis Versus Post-Dilution Hemofiltration as First Treatment of Renal Replacement Therapy in Chronic Kidney Disease: The DA-VINCI Study
Patients with chronic kidney disease (CKD) with criteria for renal replacement therapy (RRT) including uremic syndrome, have a stable state of hyperosmolarity due to urea despite not being an osmotically inactive ion. Also, these patients have alterations in urea transporters in the central nervous system (CNS) conferring a risk of neurological involvement due to an abrupt decrease in serum urea causing manifestations of the post-dialytic syndrome.
Hemodialysis results in rapid removal of urea from the blood, much faster than the equilibrium rate between the brain and the bloodstream through the blood-brain barrier, resulting in an osmotic gradient that favors movement from water to the brain, causing cerebral edema, intracranial hypertension and dialysis-associated imbalance syndrome. Conventional hemodialysis (HD) uses diffusion and primarily decreases small solutes, while hemofiltration (HF) is based on convection that provides clearance mainly of medium-size molecules and small solutes with a slower rate of reduction.
Study Overview
Status
Intervention / Treatment
Detailed Description
Currently, there is little information about which is the safest modality in the first session of intermittent hemodialysis. Other than dialysis-associated imbalance syndrome, there is no evidence exploring the neurocognitive effects of the first hemodialysis session. Cognitive impairment is defined as a new deficit in two or more areas of cognitive function and its progression is associated with impaired kidney function. Most of the dysfunctions reported are in the domains of orientation, attention and executive functions. Therefore, the recognition of cognitive impairment can be done with tools such as the Minimental State Examination (MMSE) and the Montreal Cognitive Assessment (MOCA) test. Brain magnetic resonance imaging (MRI) can identify brain lesions such as 'silent' infarcts, microbleeds and white matter abnormalities in patients with CKD with and without RRT. Diffusion-weighted MRI before and after HD has shown brain edema in rats with dialysis-associated imbalance syndrome. In fact, there is evidence from brain MRI that before first HD session patients have interstitial cerebral edema, which worsens after the first HD treatment.
Because there is no clear evidence to support the choice of the modality in the first session and the prescription is still based on personal experiences and shared views. Therefore, we conducted a pilot study to determine the safest hemodialysis modality with the lowest risks and neurocognitive effects for patients with CKD and first HD treatment.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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México City
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Mexico City, México City, Mexico, 14080
- Instituto Nacional de Cardiologia Dr. Ignacio Chavez
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age > 17 years
- Both gender
- CKD stage 5 with clinical or biochemical criteria to kidney replacement therapy initiation that includes:
- Urea nitrogen > 80 mg/dl
- Hyperkalemia
- Fluid overload
- Metabolic acidosis (ph < 7.2 and/or bicarbonate <12)
Exclusion Criteria:
- Visual disturbances
- Altered mental status at enrollment
- Hypothyroidism without optimal supplementation
- Advanced neoplasia
- Acute kidney injury
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Hemodialysis
Conventional hemodialysis
|
|
|
Experimental: Hemofiltration
Postdilutional hemofiltration
|
Postdilutional Hemofiltration
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Neurological status
Time Frame: Immediately after intervention
|
Before and after the intervention, the Minimental State Examination (MMSE) and Montreal Cognitive Assessment (MOCA) test were applied in all patients as well as brain magnetic resonance imaging (MRI) was performed in 7 patients from conventional HD group and 8 patients from post-dilution HF group before and after the intervention. We used both neurocognitive test and MRI to determine the safest HD modality (conventional hemodialysis versus hemofiltration) with the lowest neurological risks and neurocognitive effects for patients with CKD and incident RRT. |
Immediately after intervention
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PT-19-121
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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