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: Completed
• Conditions: Cognitive Impairment; Hemodialysis Complication; Cerebral Edema; Dialysis; Complications
• Intervention / Treatment: Other: Hemofiltration

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: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Mexico
  • México City
    • Mexico City, México City, Mexico, 14080
      • Instituto Nacional de Cardiologia Dr. Ignacio Chavez

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Hemodialysis; Conventional hemodialysis
Experimental: Hemofiltration; Postdilutional hemofiltration	Other: Hemofiltration; Postdilutional Hemofiltration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Immediately after intervention

Collaborators and Investigators

• Sponsor: Instituto Nacional de Cardiologia Ignacio Chavez

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2020
• Primary Completion (Actual): March 6, 2021
• Study Completion (Actual): July 1, 2021

Study Registration Dates

• First Submitted: March 31, 2021
• First Submitted That Met QC Criteria: September 16, 2021
• First Posted (Actual): September 29, 2021

Study Record Updates

• Last Update Posted (Actual): September 29, 2021
• Last Update Submitted That Met QC Criteria: September 16, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: hemodialysis; cognitive impairment; hemofiltration; brain magnetic resonance imaging; post-dialytic syndrome
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction; Brain Edema
• Other Study ID Numbers: PT-19-121

Drug and device information, study documents

• 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