NCT05060159

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 6, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 6, 2021

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

March 31, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 29, 2021

Completed
Last Updated

September 29, 2021

Status Verified

September 1, 2021

Enrollment Period

1.2 years

First QC Date

March 31, 2021

Last Update Submit

September 16, 2021

Conditions

Dialysis; ComplicationsHemodialysis ComplicationCerebral EdemaCognitive Impairment

Keywords

hemodialysishemofiltrationcognitive impairmentpost-dialytic syndromebrain magnetic resonance imaging

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Hemodialysis

NO INTERVENTION

Conventional hemodialysis

Hemofiltration

EXPERIMENTAL

Postdilutional hemofiltration

Other: Hemofiltration

Interventions

HemofiltrationOTHER

Postdilutional Hemofiltration

Hemofiltration

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • Visual disturbances
  • Altered mental status at enrollment
  • Hypothyroidism without optimal supplementation
  • Advanced neoplasia
  • Acute kidney injury

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto Nacional de Cardiología Dr. Ignacio Chávez

Mexico City, México City, 14080, Mexico

Location

Related Publications (2)

  • Kulkarni M, Prabhu AR, Rao IR, Nagaraju SP. Interventions for preventing haemodialysis dysequilibrium syndrome. Cochrane Database Syst Rev. 2024 May 22;5(5):CD015526. doi: 10.1002/14651858.CD015526.pub2.

    PMID: 38775299DERIVED

  • Jimenez EV, Nunez GC, Lerma A, Lerma C, Gonzalez AM, Perez-Grovas H, Gil SL, Madero M. Neurocognitive Function with Conventional Hemodialysis versus Post-Dilution Hemofiltration as Initial Treatment in ESKD Patients: A Randomized Controlled Trial - The DA-VINCI Study. Blood Purif. 2024;53(2):130-137. doi: 10.1159/000534823. Epub 2023 Oct 27.

    PMID: 37899042DERIVED

MeSH Terms

Conditions

Brain EdemaCognitive Dysfunction

Interventions

Hemofiltration

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesCognition DisordersNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Renal Replacement TherapyTherapeuticsExtracorporeal CirculationSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

March 31, 2021

First Posted

September 29, 2021

Study Start

January 6, 2020

Primary Completion

March 6, 2021

Study Completion

July 1, 2021

Last Updated

September 29, 2021

Record last verified: 2021-09

Locations

ME(1)