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AKINCT04762524

The Impact of CRRT Modality on Filter Life

A study testing CVVH vs CVVHD in people with AKI, run by University of Iowa at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The investigators plan to start patients who need CRRT on either CVVH or CVVHD by block randomization, and then to measure filter life. Read more about this study

Who is it for?
Ages 18 to 89 years
Conditions the study is for
AKI
What is being tested?
CVVH vs CVVHD
Could I receive a placebo?
No, everyone receives an active treatment
How many people
192 participants
Where
1 siteUnited States
Study dates
21 Mar 2020to 11 Mar 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 89 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult patients initiated on CRRT at University of Iowa Hospital

Who cannot join

  • Prisoners
  • Minors
  • ECMO use at the time of CRRT initiation

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Iowa

    Iowa City, Iowa, 52242

Other trials in United States

About this study

The investigators plan to start patients who need CRRT on either CVVH or CVVHD by block randomization, and then to measure filter life.

Read the detailed description

Continuous renal replacement therapy (CRRT) is a dialysis modality used in critically ill intensive care unit (ICU) patients because it is associated with less hemodynamic instability than traditional hemodialysis. CRRT can be conducted using one of two different modalities, which are continuous venovenous hemofiltration (CVVH) and continuous venovenous hemodialysis (CVVHD). CVVH used conductive clearance, whereas CVVHD uses diffusive clearance (CVVHD).

In CVVH, plasma water is removed across the filter using transmembrane pressure which forces fluid into the effluent space. Solutes are removed via "solvent drag", which is the process by which solutes follow fluid flow. The rate of fluid removal is high (usually around 2-3 L/hr), and so hemodynamic collapse would quickly occur in the fluid were not replaced. The patient is therefore given "replacement fluid" which can be given pre-filter or post-filter, and usually nearly matches the fluid removal rate. For instance, if 2 L are removed per hour, 2 L are given back in the form of replacement fluid, if volume neutrality is desired. If fluid removal is desired, 1.9 L (e.g) may be given back, resulting in the net loss of 0.1 L of fluid per hour. The composition of the replacement fluid determines the serum concentration. As an example, if 2 L of fluid with a potassium concentration of 6.0 mmol/L (a high amount, 4.0 is normal) is removed and replaced with 2 L of replacement fluid with a potassium concentration of 2 mmol/L, then 8 mmol of potassium will be "removed" per hour, and the potassium concentration of the serum will fall.

In CVVHD, dialysate flows in the effluent space, creating a gradient which leads to movement of solutes either into or out of the blood, depending on the gradient direction. For instance, if serum has a potassium concentration of 6 mmol/L, and the dialysate has a concentration of 2 mmol/L, potassium will move from the blood into the dialysate, until the dialysate concentration is also equal to 6 mmol/L. At that point, net potassium movement will be 0, as the concentration will be equal. As with CVVH, with a dialysate flow rate of 2 L/hr will result in the removal of 8 mmol of potassium per hour. While these technical details concern only the specialist, the important take away is that both of these modalities achieve equivalent clearance, via different mechanisms. Notably, there are no differences in clinical outcomes with use of one or the other modality, and these modalities are currently thought to have complete equipoise. The decision is generally based on provider comfort and preference. There is no clinical scenario where one modality would be preferable to the other, based on current evidence.

A major issue when using CRRT is filter clotting, which occurs on average every 30 hours. Clotting renders the circuit unusable, and requires that the machine be reset, which is a process that takes 1-2 hours on average, and potentially longer depending on the availability of the dialysis nurses who change the circuits. This results in less delivery of dialysis than what is prescribed, and clotting is often also associated with the loss of the blood that is clotted in the circuit. This could be up to 150 ccs, which is a potentially significant amount in critically ill patients. As noted within the figures, post-filter CVVH is associated with hemoconcentration, and is thought to be associated with more clotting than CVVHD, where no hemoconcentration occurs. The situation is more complicated in pre-filter CVVH, however. As in Figure 3, the fluid is initially diluted, and then the fluid is removed over the course of flow through the filter. Some Nephrologists believe that this initial dilution of the blood results in decreased risk of clotting. However, other nephrologists believe that due to differential flow rates in the blood and replacement fluid that hemoconcentration still occurs within the filter, albeit to a much lesser degree than in post-filter CVVH (this argument is difficult to explain conceptually to a lay audience, but an attempt is made within Figure 3). It is therefore unclear currently whether pre-filter CVVH and CVVHD have equal or unequal rates of clotting. Because centers tend to use exclusively one modality or the other (or a combination, which is beyond the scope of this summary), retrospective analyses are often not possible due to lack of a comparison group.

Figure 3. In pre-filter CVVH, replacement fluid is administered prior to the blood passing through the filter. Nephrologists argue about the effect this has on the rates of hemoconcentration. Some would argue that after the initial dilution, the blood only returns to its initial concentration by the end of the filter, and thus over the course of the filter, there is actually hemodilution that decreases likelihood of clotting. Other nephrologists argue like so: With a blood flow rate of 12 L/hr (standard), and a fluid flow rate of 2 L/hr, then 14 L/hr enter the fluid, and 2 L/hr are removed, which is 14% (2/14) of the fluid that entered. If the fluid flow rate is increased to 4 L/hr, then 16 L /hr enter the filter, and 4L/hr are removed, which is 25% (4/16). This would therefore theoretically result in higher degrees of clotting. The question of pre-filter CVVH and its impact on clotting relative to CVVHD is therefore unanswered, and is the reason for the proposed study."

In short, the investigators plan to start patients who need CRRT on either CVVH or CVVHD by block randomization, and then to measure how often the filters on the machine need to be replaced.

The investigators plan to exclude minors, prisoners, and patients undergoing a certain procedure called "extracorporeal membrane oxygenation" (ECMO). ECMO is designed to pump blood and provide oxygen to the patient when the heart and lungs are not working correctly (ECMO attempts to do the work of the heart and lungs in instances where the patient's organs have failed). CRRT can be added to an ECMO circuit if renal failure is also present, but this is a specialized instance with unique risk factors for clotting, and is not representative of the general CRRT population.

Conditions
AKI
Being tested
CVVH vs CVVHD

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CVVH vs CVVHDOther

    Patients are initiated on CRRT in either the CVVH or CVVHD modality

Study groups in NCT04762524
Study groupRoleWhat they receive
Initiation on CVVHExperimentalPatients in this arm were initiated on CVVH, rather than CVVHD
Receives: Other: CVVH vs CVVHD
Initiation on CVVHDActive comparatorPatients in this arm were initiated on CVVHD, rather than CVVHDH
Receives: Other: CVVH vs CVVHD

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Filter Life

    Number of hours on average until filter clots

    Measured: Until CRRT discontinuation, on average 4-5 days

Secondary outcomes (1)
  1. Mortality

    in-hospital mortality

    Measured: Through hospital discharge, on average 2-4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Feb 2021
  2. Study start21 Mar 2020
  3. Primary completion1 Mar 2021
  4. Study completion11 Mar 2021

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
192 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04762524
Sponsor's protocol ID
201909716
Status last verified
Mar 2021
First submitted
1 Feb 2021
Last updated
16 Mar 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Mann L, Ten Eyck P, Wu C, Story M, Jenigiri S, Patel J, Honkanen I, O'Connor K, Tener J, Sambharia M, Fraer M, Nourredine L, Somers D, Nizar J, Antes L, Kuppachi S, Swee M, Kuo E, Huang CL, Jalal DI, Griffin BR. CVVHD results in longer filter life than pre-filter CVVH: Results of a quasi-randomized clinical trial. PLoS One. 2023 Jan 11;18(1):e0278550. doi: 10.1371/journal.pone.0278550. eCollection 2023.

    PubMed 36630406

Questions about this trial

What is this clinical trial studying?

A study testing CVVH vs CVVHD in people with AKI, run by University of Iowa at 1 site in United States.

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 1 inclusion and 3 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 16 Mar 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 United States. 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?

Filter Life (time frame: Until CRRT discontinuation, on average 4-5 days). 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 NCT04762524, which also lists 1 linked publication.

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 16 Mar 2021.

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