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CVVHNCT05638711

Built-in Calculator Optimizes Continuous Veno-venous Hemofiltration Prescription and Improves Therapeutic Quality in Critically-ill Acute Kidney Injury Patients

An observational study of CVVH and Filtration Fraction, run by Taipei Medical University at 1 site in Taiwan.

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 goal of this observational study is to compare in ICU patients received CVVH treatment. The main questions it aims to answer are: Control of Filtration fraction by built-in calculator Reduced filter clotting and prolong filter lifespan Improve patient mortality Participants will divided into before group and after… Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
CVVH, Filtration Fraction, Built-in Culculator
What is being tested?
Built-in calculator to calculate Filtration fraction
Type of treatment
Medical device
How many people
1 participants
Where
1 siteTaiwan
Study dates
1 Jan 2019to 1 Aug 2022
Phase
Observational
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 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: ICU patients received CVVH during 2019~2021 (3 years) in our hospital, and excluded patients under age of 20, pregnant, or with HIV infection

Who may be able to join

  • ICU patients received CVVH during 2019~2021 (3 years) in our hospital

Who cannot join

  • under age of 20, pregnant, or with HIV infection

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • Shuang-Ho Hospital

    New Taipei City, Zhonghe District, 23561

Other trials in Taiwan

About this study

The goal of this observational study is to compare in ICU patients received CVVH treatment. The main questions it aims to answer are:

Control of Filtration fraction by built-in calculator

  • Reduced filter clotting and prolong filter lifespan
  • Improve patient mortality Participants will divided into before group and after group based on the day when built-in calculator for calculating Filtration fraction was utilized.

Researchers will compare before group to see if there were differences in clotting events, filter downtime, filter lifespan, mortality, etc.

Read the detailed description

# built-in calculator for calculating Filtration fraction

  • The calculator was built in prescription system since 2020/10/01
  • providing tempt filtration fraction for operators to adjust CVVH dose
  • the protocol of patient care didn't change between before and after group.
Being tested
Built-in calculator to calculate Filtration fraction

What participants receive

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

  • Built-in calculator to calculate Filtration fractionDevice

    A calculator built in electronic CVVH prescription system to calculate Filtration fraction

Study groups in NCT05638711
Study groupRoleWhat they receive
Before group* Patient: ICU patients received CVVH between 2019/01/01 - 2020/10/01 (before utilization of built-in calculator) * received regular protocol of ICU patient care (same in two groups)
After group* Patient: ICU patients received CVVH between 2020/10/01 - 2021/12/31 (after utilization of built-in calculator) * received regular protocol of ICU patient care (same in two groups)
Receives: Device: Built-in calculator to calculate Filtration fraction

What is being measured

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

  1. Mortality

    Patient death

    Measured: 30 days, 60 days, "through study completion, an average of 1.5 year" mortality in ICU and in Hospital

Secondary outcomes (11)

  1. Filter clotting events

    Filter clotting events

    Measured: "through the complete treatment course hours, an average of 24 hours"

  2. Filter lifespan

    average treatment time per filter

    Measured: "through the complete treatment course hours, an average of 24 hours"

  3. electrolytes_1

    Measured: the last record received before CVVH (in an average of 1 hour), the first record received CVVH after 24 hours, the first record received after CVVH (in an average of 1 hour)

  4. electrolytes_2

    K

    Measured: the last record received before CVVH (in an average of 1 hour), the first record received CVVH after 24 hours, the first record received after CVVH (in an average of 1 hour)

  5. electrolytes_3

    Ca

    Measured: the last record received before CVVH (in an average of 1 hour), the first record received CVVH after 24 hours, the first record received after CVVH (in an average of 1 hour)

  6. electrolytes_4

    P

    Measured: the last record received before CVVH (in an average of 1 hour), the first record received CVVH after 24 hours, the first record received after CVVH (in an average of 1 hour)

  7. acid-base balance_1

    pH

    Measured: the last record received before CVVH (in an average of 1 hour before CVVH treatment), the first record received CVVH after 24 hours (in an average of 1 hour after CVVH treatment), the first record received after CVVH (in an average of 1 hour after CVVH)

  8. acid-base balance_2

    bicarbonate

    Measured: the last record received before CVVH (in an average of 1 hour before CVVH treatment), the first record received CVVH after 24 hours (in an average of 1 hour after CVVH treatment), the first record received after CVVH (in an average of 1 hour after CVVH)

  9. Filter downtime

    downtime between filter replacement

    Measured: "through the complete treatment course hours, an average of 24 hours"

  10. others_1

    body temperature

    Measured: the last record received before CVVH (in an average of 1 hour before CVVH treatment), the first record received CVVH after 24 hours (in an average of 1 hour after CVVH treatment), the first record received after CVVH (in an average of 1 hour after CVVH)

  11. others_2

    platelet

    Measured: the last record received before CVVH (in an average of 1 hour before CVVH treatment), the first record received CVVH after 24 hours (in an average of 1 hour after CVVH treatment), the first record received after CVVH (in an average of 1 hour after CVVH)

Timeline

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

  1. First posted6 Dec 2022
  2. Study start1 Jan 2019
  3. Primary completion31 Dec 2021
  4. Study completion1 Aug 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
1 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05638711
Sponsor's protocol ID
haomingwu
Status last verified
Nov 2022
First submitted
15 Nov 2022
Last updated
6 Dec 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: there is currently no plan to make individual participant data (IPD) available to other researchers

Publications

  • Khwaja A. KDIGO clinical practice guidelines for acute kidney injury. Nephron Clin Pract. 2012;120(4):c179-84. doi: 10.1159/000339789. Epub 2012 Aug 7. No abstract available.

    PubMed 22890468

  • Davenport A. Continuous renal replacement therapies in patients with acute neurological injury. Semin Dial. 2009 Mar-Apr;22(2):165-8. doi: 10.1111/j.1525-139X.2008.00548.x.

    PubMed 19426422

  • Rabindranath K, Adams J, Macleod AM, Muirhead N. Intermittent versus continuous renal replacement therapy for acute renal failure in adults. Cochrane Database Syst Rev. 2007 Jul 18;2007(3):CD003773. doi: 10.1002/14651858.CD003773.pub3.

    PubMed 17636735

  • Wang AY, Bellomo R. Renal replacement therapy in the ICU: intermittent hemodialysis, sustained low-efficiency dialysis or continuous renal replacement therapy? Curr Opin Crit Care. 2018 Dec;24(6):437-442. doi: 10.1097/MCC.0000000000000541.

    PubMed 30247213

  • Karkar A, Ronco C. Prescription of CRRT: a pathway to optimize therapy. Ann Intensive Care. 2020 Mar 6;10(1):32. doi: 10.1186/s13613-020-0648-y.

    PubMed 32144519

  • Tsujimoto Y, Fujii T. How to Prolong Filter Life During Continuous Renal Replacement Therapy? Crit Care. 2022 Mar 22;26(1):62. doi: 10.1186/s13054-022-03910-8.

    PubMed 35337352

  • Tsujimoto H, Tsujimoto Y, Nakata Y, Fujii T, Takahashi S, Akazawa M, Kataoka Y. Pharmacological interventions for preventing clotting of extracorporeal circuits during continuous renal replacement therapy. Cochrane Database Syst Rev. 2020 Mar 13;3(3):CD012467. doi: 10.1002/14651858.CD012467.pub2.

    PubMed 32164041

  • Tsujimoto Y, Miki S, Shimada H, Tsujimoto H, Yasuda H, Kataoka Y, Fujii T. Non-pharmacological interventions for preventing clotting of extracorporeal circuits during continuous renal replacement therapy. Cochrane Database Syst Rev. 2021 Sep 14;9(9):CD013330. doi: 10.1002/14651858.CD013330.pub2.

    PubMed 34519356

  • Joannidis M, Oudemans-van Straaten HM. Clinical review: Patency of the circuit in continuous renal replacement therapy. Crit Care. 2007;11(4):218. doi: 10.1186/cc5937.

    PubMed 17634148

  • Cottle D, Mousdale S, Waqar-Uddin H, Tully R, Taylor B. Calculating evidence-based renal replacement therapy - Introducing an excel-based calculator to improve prescribing and delivery in renal replacement therapy - A before and after study. J Intensive Care Soc. 2016 Feb;17(1):44-50. doi: 10.1177/1751143715603383. Epub 2015 Sep 21.

    PubMed 28979457

  • Griffin BR, Thomson A, Yoder M, Francis I, Ambruso S, Bregman A, Feller M, Johnson-Bortolotto S, King C, Bonnes D, Dufficy L, Wu C, Bansal A, Tad-Y D, Faubel S, Jalal D. Continuous Renal Replacement Therapy Dosing in Critically Ill Patients: A Quality Improvement Initiative. Am J Kidney Dis. 2019 Dec;74(6):727-735. doi: 10.1053/j.ajkd.2019.06.013. Epub 2019 Sep 17.

    PubMed 31540789

  • Ruiz EF, Ortiz-Soriano VM, Talbott M, Klein BA, Thompson Bastin ML, Mayer KP, Price EB, Dorfman R, Adams BN, Fryman L, Neyra JA; University of Kentucky CRRT Quality Assurance Group. Development, implementation and outcomes of a quality assurance system for the provision of continuous renal replacement therapy in the intensive care unit. Sci Rep. 2020 Nov 26;10(1):20616. doi: 10.1038/s41598-020-76785-w.

    PubMed 33244053

  • Honore PM, Spapen HD. What a Clinician Should Know About a Renal Replacement Membrane? J Transl Int Med. 2018 Jun 26;6(2):62-65. doi: 10.2478/jtim-2018-0016. eCollection 2018 Jun. No abstract available.

    PubMed 29984198

  • Yessayan L, Yee J, Frinak S, Szamosfalvi B. Continuous Renal Replacement Therapy for the Management of Acid-Base and Electrolyte Imbalances in Acute Kidney Injury. Adv Chronic Kidney Dis. 2016 May;23(3):203-10. doi: 10.1053/j.ackd.2016.02.005.

    PubMed 27113697

  • Kraut JA, Madias NE. Metabolic acidosis: pathophysiology, diagnosis and management. Nat Rev Nephrol. 2010 May;6(5):274-85. doi: 10.1038/nrneph.2010.33. Epub 2010 Mar 23.

    PubMed 20308999

Questions about this trial

What is this clinical trial studying?

An observational study of CVVH and Filtration Fraction, run by Taipei Medical University at 1 site in Taiwan.

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 1 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 6 Dec 2022. 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 Taiwan. 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?

Mortality (time frame: 30 days, 60 days, "through study completion, an average of 1.5 year" mortality in ICU and in Hospital). 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 NCT05638711, which also lists 17 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 6 Dec 2022.

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