- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05638711
Built-in Calculator Optimizes Continuous Veno-venous Hemofiltration Prescription and Improves Therapeutic Quality in Critically-ill Acute Kidney Injury Patients
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Zhonghe District
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New Taipei City, Zhonghe District, Taiwan, 23561
- Shuang-Ho Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- ICU patients received CVVH during 2019~2021 (3 years) in our hospital
Exclusion Criteria:
- under age of 20, pregnant, or with HIV infection
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Before group
|
|
|
After group
|
A calculator built in electronic CVVH prescription system to calculate Filtration fraction
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mortality
Time Frame: 30 days, 60 days, "through study completion, an average of 1.5 year" mortality in ICU and in Hospital
|
Patient death
|
30 days, 60 days, "through study completion, an average of 1.5 year" mortality in ICU and in Hospital
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Filter clotting events
Time Frame: "through the complete treatment course hours, an average of 24 hours"
|
Filter clotting events
|
"through the complete treatment course hours, an average of 24 hours"
|
|
Filter lifespan
Time Frame: "through the complete treatment course hours, an average of 24 hours"
|
average treatment time per filter
|
"through the complete treatment course hours, an average of 24 hours"
|
|
electrolytes_1
Time Frame: 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)
|
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)
|
|
|
electrolytes_2
Time Frame: 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)
|
K
|
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)
|
|
electrolytes_3
Time Frame: 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)
|
Ca
|
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)
|
|
electrolytes_4
Time Frame: 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)
|
P
|
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)
|
|
acid-base balance_1
Time Frame: 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)
|
pH
|
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)
|
|
acid-base balance_2
Time Frame: 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)
|
bicarbonate
|
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)
|
|
Filter downtime
Time Frame: "through the complete treatment course hours, an average of 24 hours"
|
downtime between filter replacement
|
"through the complete treatment course hours, an average of 24 hours"
|
|
others_1
Time Frame: 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)
|
body temperature
|
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)
|
|
others_2
Time Frame: 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)
|
platelet
|
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)
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General 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.
- 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. Review.
- 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;(3):CD003773. doi: 10.1002/14651858.CD003773.pub3.
- 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. Review.
- 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. Review.
- 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. Review.
- 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:CD012467. doi: 10.1002/14651858.CD012467.pub2. Update in: Cochrane Database Syst Rev. 2020 Dec 14;12:CD012467.
- 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:CD013330. doi: 10.1002/14651858.CD013330.pub2. Review.
- Joannidis M, Oudemans-van Straaten HM. Clinical review: Patency of the circuit in continuous renal replacement therapy. Crit Care. 2007;11(4):218. Review.
- 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.
- 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.
- 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.
- 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.
- 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. Review.
- 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.
- Rocktäschel J, Morimatsu H, Uchino S, Ronco C, Bellomo R. Impact of continuous veno-venous hemofiltration on acid-base balance. Int J Artif Organs. 2003 Jan;26(1):19-25.
- Leypoldt JK, Pietribiasi M, Echeverri J, Harenski K. Modeling acid-base balance during continuous kidney replacement therapy. J Clin Monit Comput. 2022 Feb;36(1):179-189. doi: 10.1007/s10877-020-00635-3. Epub 2021 Jan 3.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- haomingwu
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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