Optimizing fluid management to improve recovery time in patients treated with Hemodialysis: A stepped-wedge cluster randomized trial using the Recova® decision aid
| ISRCTN | ISRCTN86689208 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN86689208 |
| Secondary identifying numbers | FOU2022-00112 |
- Submission date
- 22/10/2025
- Registration date
- 28/10/2025
- Last edited
- 27/10/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Plain English summary of protocol
Background and study aims
Haemodialysis (HD) is a life-saving treatment for people with severe kidney disease. It can be used while waiting for a kidney transplant, but for many people it becomes a lifelong treatment. Most patients need dialysis three times a week, for about four to five hours each time.
An important part of dialysis care is managing the amount of fluid in the body. If too much fluid is removed, patients can feel weak, dizzy or tired. If too little is removed, it can cause swelling or heart problems. Finding the right balance is therefore very important for both short- and long-term health.
Many patients also feel tired after dialysis. The time it takes to feel fully recovered after a session is called recovery time (RT), and this has a big impact on quality of life.
This study looks at a decision-support tool called Recova®, which helps healthcare staff manage patients’ fluid balance. Recova® combines clinical assessments with a method called bioimpedance spectroscopy (BIS) to better understand how much fluid is in the body. The aim of the study is to find out whether using Recova® can improve fluid management and shorten recovery time after dialysis. The study followed patients for 12 weeks.
Who can participate?
Adults with chronic kidney disease who receive regular haemodialysis and need fluid removal as part of their treatment.
What does the study involve?
The Recova® tool was introduced in 10 dialysis clinics across Sweden. Healthcare professionals were trained to use it and to regularly check patients’ symptoms and signs of fluid imbalance. Each patient was assessed every two weeks, for a total of six times over the 12-week study period.
The main things measured were: 1) Fluid balance, using bioimpedance spectroscopy (BIS) and 2) Recovery time, using the question: “How long does it take you to feel recovered after dialysis?”
A secondary measure was a volume status score, based on the Recova® assessment.
Before and after the 12-week period, results were compared to see if there were any changes.
What are the possible benefits and risks of participating?
There are no direct or immediate benefits for patients who take part in this study. However, in the long term, the results may help improve dialysis care and lead to more personalised treatments for future patients.
Completing the questionnaires may also give participants a chance to reflect on their own health and care needs. Many people find it meaningful to take part in research that can increase knowledge and help improve care for others in the future.
Previous studies have shown that healthcare staff appreciate having tools like Recova® to help them regularly and systematically assess dialysis patients’ symptoms.
The study is based on safe and established treatment methods and does not involve any medical risks. The main potential risk relates to privacy, since some health information will be collected from medical records and from the Swedish Renal Registry (SNR). However, all patients included in the SNR have already given consent for their information to be used in research.
Patients who take part in the study will: Complete questionnaires about their health and quality of life (this takes about 20 minutes); Take part in a few simple physical tests during their regular dialysis sessions; Have two extra fluid measurement (bioimpedance test), which takes about 10 extra minutes.
Any discomfort from these activities is expected to be very small.
Where is the study run from?
The study is coordinated from Uppsala, Sweden, and involves 10 dialysis clinics across five Swedish regions.
When is the study starting and how long is it expected to run for?
The study started in August 2022, and data collection was completed in June 2024.
Who is funding the study?
• Uppsala University Hospital ALF grants and establishment funding
• CUWX Foundation
• The Swedish Kidney Foundation
• The Regional Research Council Mid-Sweden (RFR-981084)
Who is the main contact?
Jenny Stenberg, RN, MSc, PhD, jenny.stenberg@medsci.uu.se
Contact information
Public, Scientific, Principal investigator
Oscar II-dialysmottagningen
Dag Hammarskjölds väg 10 A
Uppsala
75185
Sweden
 ORCID ID |
0000-0003-2408-0087 |
|---|---|
| Phone | +46708880799 |
| jenny.stenberg@medsci.uu.se |
Scientific
Akademiska sjukhuset, ingång 40, 5 tr
Uppsala
751 85
Sweden
| ORCID ID |
0000-0001-7545-5585 |
|---|---|
| Phone | +46-18-471 00 00 |
| maria.k.svensson@ucr.uu.se |
Study information
| Study design | Stepped-wedge cluster randomized study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | Hospital |
| Study type | Quality of life, Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | Optimizing fluid management to improve recovery time in patients treated with Hemodialysis: A stepped-wedge cluster randomized trial using the Recova® decision aid |
| Study acronym | Recova-Recovery |
| Study objectives | To evaluate if use of Recova® contributed improved fluid management assessed as changes in fluid status and self-reported time to recovery after dialysis. |
| Ethics approval(s) |
Approved 08/04/2022, Swedish Ethical Review Authority (Etikprövningsmyndigheten Box 2110, Uppsala, 750 02, Sweden; +46-10-475 08 00; registrator@etikprovning.se), ref: 2021-06796-01 |
| Health condition(s) or problem(s) studied | Chronic kidney disease treated with hemodialysis |
| Intervention | A stepped-wedge cluster randomized trial was conducted across 10 hemodialysis (HD) clinics in five Swedish regions; each clinic was considered a cluster. Recognition and Correction of Volume Alterations (Recova®), a fluid management decision aid combining clinical assessments with bioimpedance spectroscopy (BIS), was implemented at each clinic. A protocol for symptom assessment was provided for each study participant, and the healthcare professionals were trained to assess and respond to the patients' signs and symptoms every 14 days, on six occasions. The intervention period was 12 weeks, and the effect was assessed with pre- and post-intervention measurements in each study participant. The clinics were included and assigned to the intervention consecutively, based on their availability. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Fluid status and recovery time were measured using bioimpedance spectroscopy and patients answering, "How long does it take you to recover from dialysis?" at baseline and after 12 weeks exposure to the intervention. |
| Secondary outcome measures | Volume status scores were measured using Recova® every second week during the 12 weeks intervention period i.e. at six occasions. |
| Overall study start date | 01/10/2021 |
| Completion date | 02/01/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target number of participants | 10 clusters with 8 - 21 patients per cluster |
| Total final enrolment | 129 |
| Key inclusion criteria | Patients over 18 years of age who had been treated with hemodialysis for more than three months |
| Key exclusion criteria | 1. Patients with critical illness 2. Expected survival less than 6 months 3. Inability to provide informed consent - due to language or cognitive insufficiency 4. Home-HD treatment 5. Pacemaker 6. Did not have a documented need for ultrafiltration |
| Date of first enrolment | 24/08/2022 |
| Date of final enrolment | 02/01/2024 |
Locations
Countries of recruitment
- Sweden
Study participating centres
Karlskoga
691 81
Sweden
Mora
792 85
Sweden
Örebro
701 85
Sweden
Gävle
801 87
Sweden
Bollnäs
821 81
Sweden
STOCKHOLM
118 83
Sweden
Falun
791 82
Sweden
Linköping
581 85
Sweden
Motala
591 85
Sweden
Sponsor information
University/education
Akademiska sjukhuset, ingång 40, 5 tr
Uppsala
751 85
Sweden
| Phone | +46-18-471 00 00 |
|---|---|
| registrator@uu.se | |
| Website | https://www.uu.se/en/ |
"ROR" |
https://ror.org/048a87296 |
Funders
Funder type
University/education
Private sector organisation / Universities (academic only)
- Alternative name(s)
- Uppsala University Hospital
- Location
- Sweden
No information available
Private sector organisation / Trusts, charities, foundations (both public and private)
- Location
- Sweden
No information available
Results and Publications
| Intention to publish date | 31/12/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a peer reviewed journal |
| IPD sharing plan | The datasets generated and/or analysed during the current study will not be publicly available due to their containing information that could compromise the privacy of research participants - but are available from the corresponding author on reasonable request. The study data will be stored in a separate database requiring authentication for access. All data will be stored for 10 years after the study is completed and then archived at Uppsala University Hospital in accordance with current archive legislation. |
Editorial Notes
23/10/2025: Study's existence confirmed by the Swedish Ethical Review Authority, Sweden.
