Dialysis; ComplicationsDA-VINCINCT05060159
Conventional Hemodialysis Versus Post-Dilution Hemofiltration in Incident RRT
A study testing Hemofiltration in people with Dialysis; Complications and Hemodialysis Complication, run by Instituto Nacional de Cardiologia Ignacio Chavez at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Dialysis; Complications, Hemodialysis Complication, Cerebral Edema
- What is being tested?
- Hemofiltration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteMexico
- Study dates
- 6 Jan 2020to 1 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Visual disturbances
- Altered mental status at enrollment
- Hypothyroidism without optimal supplementation
- Advanced neoplasia
- Acute kidney injury
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Instituto Nacional de Cardiología Dr. Ignacio Chávez
Mexico City, México City, 14080
About this study
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
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.
Read the 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.
- Being tested
- Hemofiltration
- Keywords
- hemodialysis, hemofiltration, cognitive impairment, post-dialytic syndrome, brain magnetic resonance imaging
- Medical subject headings
- Brain Edema, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HemofiltrationOther
Postdilutional Hemofiltration
| Study group | Role | What they receive |
|---|---|---|
| Hemodialysis | No intervention | Conventional hemodialysis |
| Hemofiltration | Experimental | Postdilutional hemofiltration Receives: Other: Hemofiltration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediately after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2021
- Study start6 Jan 2020
- Primary completion6 Mar 2021
- Study completion1 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Dialysis; ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Cardiologia Ignacio Chavez
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Magdalena Madero, Instituto Nacional de Cardiologia Ignacio Chavez
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05060159
- Sponsor's protocol ID
- PT-19-121
- Acronym
- DA-VINCI
- Status last verified
- Sep 2021
- First submitted
- 31 Mar 2021
- Last updated
- 29 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38775299Jimenez 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.
PubMed 37899042
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05060159
- Acronym / sponsor ID
- DA-VINCI / PT-19-121
- Keywords
- hemodialysis, hemofiltration, cognitive impairment, post-dialytic syndrome, brain magnetic resonance imaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Instituto Nacional de Cardiologia Ignacio ChavezUniversity, hospital or other
- Study start
- 6 Jan 2020 (actual)
- Primary completion
- 6 Mar 2021 (actual)
- Study completion
- 1 Jul 2021 (actual)
- First posted
- 29 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hemodialysis | No intervention | –Conventional hemodialysis |
| Hemofiltration | Experimental | Other: HemofiltrationPostdilutional hemofiltration |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- Visual disturbances
- Altered mental status at enrollment
- Hypothyroidism without optimal supplementation
- Advanced neoplasia
- Acute kidney injury
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HemofiltrationPostdilutional Hemofiltration | Other | Hemofiltration |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2021.
- Derived from this study: PubMed 38775299Kulkarni 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.
- Derived from this study: PubMed 37899042Jimenez 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hemofiltration in people with Dialysis; Complications and Hemodialysis Complication, run by Instituto Nacional de Cardiologia Ignacio Chavez at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neurological status (time frame: Immediately after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05060159, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2021.