Renal Replacement TherapiesNCT07426575
Evaluating the Usability of New Dialysis Bags
An observational study of Renal Replacement Therapies, run by Erasmus Medical Center at 1 site in Netherlands.
Trial summary
Objective: To compare the usability, efficiency, and ergonomics of new dialysis bags with current bags from the nursing perspective in ICU settings. Study Type: Prospective, single-center observational study. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Renal Replacement Therapies
- How many people
- 126 participants
- Where
- 1 siteNetherlands
- Study dates
- 15 Feb 2026to 30 Aug 2026
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: ICU nurses
Who may be able to join
- Nurse working in an adult intensive care unit (ICU)
- Competent in performing continuous renal replacement therapy (CRRT)
Who cannot join
- Nurses with less than 6 months of experience in administering CRRT, to ensure sufficient experience for a valid head-to-head comparison with the older dialysis bags.
- Nurses who are not directly involved in the handling or replacement of dialysis bags during CRRT procedures.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating the Usability of New Dialysis Bags for Continuous Renal Replacement Therapy: A Survey Among ICU Nurses
Objective: To compare the usability, efficiency, and ergonomics of new dialysis bags with current bags from the nursing perspective in ICU settings.
Study Type: Prospective, single-center observational study.
Methods: ICU nurses (126 total) will complete two surveys (pre- and post-implementation) evaluating both dialysis bags.
Read the detailed description
Rationale Continuous renal replacement therapy (CRRT) is commonly performed in adult ICUs, using large and heavy dialysate bags that require manual mixing, which can be cumbersome and time-consuming for ICU nurses. These bags are integral to the CRRT procedure but may introduce inefficiencies and safety concerns. With the introduction of newer dialysate bags designed for a lower environmental impact, it is important to evaluate how these new bags compare to the current products in terms of usability. The central question of this study is whether the new dialysis bags offer improved usability, efficiency, and ergonomic benefits for ICU nurses.
Objective(s) assess and compare the usability of the new dialysis bags with the currently used dialysis bags from the nursing perspective. The study will focus on evaluating ease of use, identifying problems encountered during use, and measuring efficiency during CRRT in an ICU setting.
Study type The study is a prospective, single-center research design. The study will be conducted in an ICU setting where nurses will be asked to evaluate the current and new dialysis bags at two time points: pre-implementation (evaluation of current bags) and post-implementation (evaluation of new bags).
Study population The study will include adult ICU nurses with at least 6 months of experience in administering CRRT. A total of 126 nurses (63 evaluating the current bags, 63 evaluating the new bags) will be invited to complete the usability questionnaire.
Methods The study will employ a two-time-point survey design. Nurses will first complete a survey evaluating the current dialysis bags. After approximately two months of using the new bags, a second survey will be conducted to assess the new bags. Both surveys will include Likert-scale questions and open-ended responses, focusing on the usability, safety, and efficiency of the dialysis bags. In the post-implementation survey, a head-to-head comparison will be included to directly compare the old and new bags across key usability domains such as ease of mixing, connection, leakage/contamination risks, changeover time, and ergonomic burden.
Burden and risks The burden on participants will be minimal, as the study involves completing two digital questionnaires (pre- and post-implementation). Participation will not interfere with clinical duties or patient care. There are no physical procedures or medical interventions involved, and the study poses no significant risks to participants.
Recruitment and consent Nurses will be recruited directly from the ICU and informed directly by a member of the research team. Participants will receive an information letter (PIF) describing the study's purpose, procedures, and voluntary nature. Informed consent will be obtained before participation. Participation is voluntary, and nurses may withdraw at any time without consequences for their employment or professional activities.
- Conditions
- Renal Replacement Therapies
- Keywords
- acute kidney disease, Renal replacement therapy, Evalatuion study, ICU nurses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ICU nurses | ICU nurses with at least 6 months of experience in administering CRRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
usability
To assess the usability of the new dialysis bags compared to the current bags. This will be measured using Likert-scale responses from the usability survey, focusing on ease of use, safety, and efficiency during CRRT procedures. A head-to-head comparison will be performed
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2026
- Study start15 Feb 2026
- Primary completion1 Aug 2026
- Study completion30 Aug 2026
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 Renal Replacement TherapiesStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Cornelis van Herwerden, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07426575
- Sponsor's protocol ID
- MEC-2025-0747
- Status last verified
- Sep 2026
- First submitted
- 15 Feb 2026
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: On reasable request data will be shared
Publications
Colligan L, Potts HW, Finn CT, Sinkin RA. Cognitive workload changes for nurses transitioning from a legacy system with paper documentation to a commercial electronic health record. Int J Med Inform. 2015 Jul;84(7):469-76. doi: 10.1016/j.ijmedinf.2015.03.003. Epub 2015 Mar 22.
PubMed 25868807Hyzy M, Bond R, Mulvenna M, Bai L, Dix A, Leigh S, Hunt S. System Usability Scale Benchmarking for Digital Health Apps: Meta-analysis. JMIR Mhealth Uhealth. 2022 Aug 18;10(8):e37290. doi: 10.2196/37290.
PubMed 35980732
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Usability of New Dialysis Bags for Continuous Renal Replacement Therapy: A Survey Among ICU Nurses
- ClinicalTrials.gov ID
- NCT07426575
- Acronym / sponsor ID
- MEC-2025-0747
- Conditions
- Renal Replacement Therapies
- Keywords
- acute kidney disease, Renal replacement therapy, Evalatuion study, ICU nurses
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Study start
- 15 Feb 2026 (actual)
- Primary completion
- 1 Aug 2026 (actual)
- Study completion
- 30 Aug 2026 (actual)
- First posted
- 23 Feb 2026 (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.
Objective: To compare the usability, efficiency, and ergonomics of new dialysis bags with current bags from the nursing perspective in ICU settings.
Study Type: Prospective, single-center observational study.
Methods: ICU nurses (126 total) will complete two surveys (pre- and post-implementation) evaluating both dialysis bags.
Detailed description
Rationale Continuous renal replacement therapy (CRRT) is commonly performed in adult ICUs, using large and heavy dialysate bags that require manual mixing, which can be cumbersome and time-consuming for ICU nurses. These bags are integral to the CRRT procedure but may introduce inefficiencies and safety concerns. With the introduction of newer dialysate bags designed for a lower environmental impact, it is important to evaluate how these new bags compare to the current products in terms of usability. The central question of this study is whether the new dialysis bags offer improved usability, efficiency, and ergonomic benefits for ICU nurses.
Objective(s) assess and compare the usability of the new dialysis bags with the currently used dialysis bags from the nursing perspective. The study will focus on evaluating ease of use, identifying problems encountered during use, and measuring efficiency during CRRT in an ICU setting.
Study type The study is a prospective, single-center research design. The study will be conducted in an ICU setting where nurses will be asked to evaluate the current and new dialysis bags at two time points: pre-implementation (evaluation of current bags) and post-implementation (evaluation of new bags).
Study population The study will include adult ICU nurses with at least 6 months of experience in administering CRRT. A total of 126 nurses (63 evaluating the current bags, 63 evaluating the new bags) will be invited to complete the usability questionnaire.
Methods The study will employ a two-time-point survey design. Nurses will first complete a survey evaluating the current dialysis bags. After approximately two months of using the new bags, a second survey will be conducted to assess the new bags. Both surveys will include Likert-scale questions and open-ended responses, focusing on the usability, safety, and efficiency of the dialysis bags. In the post-implementation survey, a head-to-head comparison will be included to directly compare the old and new bags across key usability domains such as ease of mixing, connection, leakage/contamination risks, changeover time, and ergonomic burden.
Burden and risks The burden on participants will be minimal, as the study involves completing two digital questionnaires (pre- and post-implementation). Participation will not interfere with clinical duties or patient care. There are no physical procedures or medical interventions involved, and the study poses no significant risks to participants.
Recruitment and consent Nurses will be recruited directly from the ICU and informed directly by a member of the research team. Participants will receive an information letter (PIF) describing the study's purpose, procedures, and voluntary nature. Informed consent will be obtained before participation. Participation is voluntary, and nurses may withdraw at any time without consequences for their employment or professional activities.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ICU nurses | – | –ICU nurses with at least 6 months of experience in administering CRRT |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- ICU nurses
Key inclusion criteria (2 listed)
- Nurse working in an adult intensive care unit (ICU)
- Competent in performing continuous renal replacement therapy (CRRT)
Key exclusion criteria (2 listed)
- Nurses with less than 6 months of experience in administering CRRT, to ensure sufficient experience for a valid head-to-head comparison with the older dialysis bags.
- Nurses who are not directly involved in the handling or replacement of dialysis bags during CRRT procedures.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
usability
Time frame: 4 months
To assess the usability of the new dialysis bags compared to the current bags. This will be measured using Likert-scale responses from the usability survey, focusing on ease of use, safety, and efficiency during CRRT procedures. A head-to-head comparison will be performed
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 11 Sep 2026.
- Background: PubMed 25868807Colligan L, Potts HW, Finn CT, Sinkin RA. Cognitive workload changes for nurses transitioning from a legacy system with paper documentation to a commercial electronic health record. Int J Med Inform. 2015 Jul;84(7):469-76. doi: 10.1016/j.ijmedinf.2015.03.003. Epub 2015 Mar 22.
- Background: PubMed 35980732Hyzy M, Bond R, Mulvenna M, Bai L, Dix A, Leigh S, Hunt S. System Usability Scale Benchmarking for Digital Health Apps: Meta-analysis. JMIR Mhealth Uhealth. 2022 Aug 18;10(8):e37290. doi: 10.2196/37290.
- Individual participant dataSharing planned: Undecided. On reasable request data will be shared
Related trials for Renal Replacement Therapies
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
Not yet recruitingObservational study
Diastolic Shock Index for Predicting Hemodynamic Instability During Continuous Renal Replacement Therapy
Acute Kidney Injury, Hypotension (MeSH: D007022)
Not yet recruitingObservational study
Pharmacokinetics and Optimal Dosing of Levetiracetam in Critically Ill Patients Undergoing Continuous Renal Replacement Therapy
Continuous Renal Replacement Therapy (CRRT), Pharmacokinetics
Not yet recruiting
Negative Pressure Wound Therapy Devices in Total Knee Arthroplasty
Wound Surgical, Diabetes
Recruiting
Early Deresuscitation Strategy Driven by Tissue Perfusion in Renal Replacement Therapy in Patients With Acute Renal Failure
Acute Kidney Injury, Fluid Overload
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?
An observational study of Renal Replacement Therapies, run by Erasmus Medical Center at 1 site in Netherlands.
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 2 inclusion and 2 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 11 Sep 2026. 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 Netherlands. 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?
usability (time frame: 4 months). 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 NCT07426575, 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 11 Sep 2026.