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Conventional Hemodialysis Versus Post-Dilution Hemofiltration in Incident RRT (DA-VINCI)

Primary Purpose

Dialysis; Complications, Hemodialysis Complication, Cerebral Edema

Status
Completed
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Hemofiltration
Sponsored by
Instituto Nacional de Cardiologia Ignacio Chavez
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dialysis; Complications focused on measuring hemodialysis, hemofiltration, cognitive impairment, post-dialytic syndrome, brain magnetic resonance imaging

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Instituto Nacional de Cardiología Dr. Ignacio Chávez

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Hemodialysis

Hemofiltration

Arm Description

Conventional hemodialysis

Postdilutional hemofiltration

Outcomes

Primary Outcome Measures

Neurological status
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.

Secondary Outcome Measures

Full Information

First Posted
March 31, 2021
Last Updated
September 16, 2021
Sponsor
Instituto Nacional de Cardiologia Ignacio Chavez
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1. Study Identification

Unique Protocol Identification Number
NCT05060159
Brief Title
Conventional Hemodialysis Versus Post-Dilution Hemofiltration in Incident RRT
Acronym
DA-VINCI
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
January 6, 2020 (Actual)
Primary Completion Date
March 6, 2021 (Actual)
Study Completion Date
July 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto Nacional de Cardiologia Ignacio Chavez

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dialysis; Complications, Hemodialysis Complication, Cerebral Edema, Cognitive Impairment
Keywords
hemodialysis, hemofiltration, cognitive impairment, post-dialytic syndrome, brain magnetic resonance imaging

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hemodialysis
Arm Type
No Intervention
Arm Description
Conventional hemodialysis
Arm Title
Hemofiltration
Arm Type
Experimental
Arm Description
Postdilutional hemofiltration
Intervention Type
Other
Intervention Name(s)
Hemofiltration
Intervention Description
Postdilutional Hemofiltration
Primary Outcome Measure Information:
Title
Neurological status
Description
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.
Time Frame
Immediately after intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Instituto Nacional de Cardiología Dr. Ignacio Chávez
City
Mexico City
State/Province
México City
ZIP/Postal Code
14080
Country
Mexico

12. IPD Sharing Statement

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Conventional Hemodialysis Versus Post-Dilution Hemofiltration in Incident RRT

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