Effects of drinking water quantity and quality on rehabilitation outcomes in critically ill patients
| ISRCTN | ISRCTN55840708 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN55840708 |
| Secondary identifying numbers | 27125 |
- Submission date
- 24/01/2025
- Registration date
- 29/01/2025
- Last edited
- 29/01/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Other
Plain English summary of protocol
Background and study aims
Critical illness often leaves patients with long-term physical, emotional, and cognitive challenges even after they leave intensive care. Early rehabilitation during recovery can significantly improve their quality of life. While hydration is a critical component of recovery, current research mostly focuses on how much water is consumed, with limited attention to its quality. This study, called the WAVES Protocol, aims to explore how both individualized hydration strategies and the quality of water affect recovery in critically ill patients during their first month of inpatient rehabilitation. The results could provide new insights into improving hydration practices and rehabilitation outcomes.
Who can participate?
Participants must be aged 18 to 85 and have recently been discharged from an ICU after spending at least five days there due to a critical illness. They should be able to drink fluids either on their own or with minimal support.
What does the study involve?
The pilot trial will include 50 participants (the main study involves 400 participants) randomly assigned to one of four groups: two groups will follow personalized hydration plans, and two will drink water freely without specific guidance. Within each pair, one group will consume artesian spring water, and the other will drink natural mineral water. Personalized hydration plans are designed using advanced tools that calculate water needs based on age, weight, activity level, and other factors. Over four weeks, participants will undergo tests to measure their recovery, including assessments of their ability to perform daily activities, cognitive function, emotional health, and physical strength. Biomarkers in their blood will also be analyzed to understand the role of hydration in reducing inflammation and improving metabolic function.
What are the possible benefits and risks of participating?
Participants may benefit from improved recovery through personalized hydration plans tailored to their individual needs. Additionally, they will contribute to valuable research that could benefit future patients undergoing rehabilitation. Risks include mild discomfort from blood sample collection and possible side effects from changes in fluid balance, though these will be closely monitored by healthcare professionals.
Where is the study run from?
The study is managed by GREEC (independent research group), based in Germany, with clinical activities taking place at Schön Klinik Bad Aibling in Germany.
When is the study starting and how long is it expected to run for?
January 2024 to January 2029. The study will start recruiting in February 2025 and is expected to last for approximately 24 months, including a pilot phase to ensure feasibility.
Who is funding the study?
The study is funded by Schoen Klinik Bad Aibling and Alpine Water GmbH (i.e., providing the investigational water products).
Who is the main contact?
Marion Egger, PhD, megger@schoen-klinik.de
Contact information
Principal Investigator
Schön Klinik Bad Aibling
Kolbermoorer Str. 72
Bad Aibling
83043
Germany
| Phone | +49 8061 9030 |
|---|---|
| kljahn@schoen-klinik.de |
Scientific
Schön Klinik Bad Aibling
Kolbermoorer Str. 72
Bad Aibling
83043
Germany
| Phone | +49 8061 9030 |
|---|---|
| megger@schoen-klinik.de |
Public
Schön Klinik Bad Aibling
Kolbermoorer Str. 72
Bad Aibling
83043
Germany
| Phone | +49 8061 9030 |
|---|---|
| simon@greec.org |
Study information
| Study design | Interventional single-center triple-blind randomized controlled trial and pilot study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Quality of life, Treatment, Efficacy |
| Participant information sheet | Not available in web Format, please use contact details to request a participant information sheet |
| Scientific title | Drinking water variability effect study in early rehabilitation |
| Study acronym | WAVES |
| Study objectives | While the study is exploratory in nature, the primary hypothesis constitutes that a quantitatively individualized hydration regimen improves clinical outcomes in individuals recovering from critical illness. The secondary hypothesis states that drinking water characteristics significantly modify clinical outcomes in individuals recovering from critical illness. |
| Ethics approval(s) |
Approved 15/10/2024, Ethics Committee of The Faculty of Medicine at Ludwig Maximilians University Munich (Geschwister-Scholl-Platz 1, Munich, 80539, Germany; +498921800; ethikkommission@med.uni-muenchen.de), ref: 24-0729 |
| Health condition(s) or problem(s) studied | Critical illness |
| Intervention | 1. Individualized hydration regimens: Patients will receive either individualized drinking water volumes (i.e., bioimpedance, HidrateSmart, bio markers, thirst sensation) or consume drinking water ad libitum. 2. Drinking water characteristics: Participants will either receive either artesian spring water or natural mineral water. Duration: 4 weeks. Administration: Per os. Standard treatment as applicable to both groups: All participants will undergo an inpatient early neurorehabilitation program at a specialized hospital in Germany. General: 2:2 design; permuted block randomization for pilot, cluster randomization for main study |
| Intervention type | Behavioural |
| Primary outcome measure | Clinical rehabilitation outcomes measured using Barthel Index Scores on days 1 and 28 |
| Secondary outcome measures | 1. Cognitive performance measured using the Montreal Cognitive Assessment (MoCA) at baseline, after 2 weeks, and after 4 weeks 2. Depression and anxiety measured using the Hospital Anxiety and Depression Scale (HADS) at baseline, after 2 weeks, and after 4 weeks 3. Sleep Quality measured using the PROMIS Sleep Disturbance Short Form (PROMIS SDSF) at baseline, after 2 weeks, and after 4 weeks 4. Thirst Sensation measured using a 10-point Likert Scale at baseline, after 1 week, after 2 weeks, after 3 weeks, and after 4 weeks 5. Fatigue measured using the Fatigue Severity Scale (FSS) at baseline, after 2 weeks, and after 4 weeks 6. Quality of Life measured using the European Quality of Life 5 Dimensions 5 Level Version (5Q5D5L) at baseline, after 2 weeks, and after 4 weeks 7. Physical Strength measured using the dynamometer test at baseline, after 1 week, after 2 weeks, after 3 weeks, and after 4 weeks 8. Hydration status measured using bioimpedance at baseline, after 1 week, after 2 weeks, after 3 weeks, and after 4 weeks 9. Cardiovascular performance measured using a 2-minute walk test (2MWT) at baseline, after 2 weeks, and after 4 weeks 10. Inflammation measured by quantifying the serum levels of high-sensitivity C-reactive protein (hs-CRP), Interleukin 6 (IL-6), IL-8, tumor necrosis factor (TNF)-alpha, and interferon (IF)-gamma using enzyme-linked immunosorbent assay (ELISA) or multiplex immunoassay at baseline and 4 weeks. 11. Renal function measured by quantifying the serum levels of urea, eGFR (CKD-EPI), electrolytes, albumin, and creatinine using autoanalyzer-based biochemical methods or spectrophotometric assays at baseline and 4 weeks 12. Metabolic function measured by quantifying serum pH, lactate and creatine kinase (CK) using arterial blood gas analysis (for pH and lactate) and spectrophotometric enzymatic assay (for CK) at baseline and 4 weeks 13. Oxidative stress measured by quantifying total antioxidative capacity and glutathione using spectrophotometric assays (e.g., ferric-reducing antioxidant power [FRAP] for total antioxidative capacity) and glutathione-specific fluorometric or colorimetric assays at baseline and 4 weeks 14. Hydration parameters measured by quantifying plasma osmolality using freezing point depression osmometry at baseline and 4 weeks |
| Overall study start date | 10/01/2024 |
| Completion date | 27/01/2029 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 85 Years |
| Sex | Both |
| Target number of participants | 50 for pilot (400 for main trial) |
| Key inclusion criteria | Subjects must meet all study inclusion criteria as outlined below: 1. Critical illness survivor: Status post ≥ 5 days ICU treatment 2. Ability to ingest adequate amounts of fluid without / with minimal support 3. Age 18 to 85 years 4. All genders 5. Full-term (at least 4 weeks) participation in an inpatient neurorehabilitation program (Schön Clinics rehabilitation program) 6. Cognitive and physiological (i.e., eyesight) ability to perceive and react to visual alarm |
| Key exclusion criteria | Subjects meeting any of the following exclusion criteria will not be eligible to participate in the study: 1. Current use of PEG or nasogastral tube for TPN 2. Insufficient (German) communication skills to complete the questionnaires 3. Pregnancy/lactation 4. Current malignancy 5. Advanced heart disease ≥ NYHA 3 6. Advanced kidney disease and/or dialysis 7. Hyponatremia 8. Participation in other study 9. Palliative care 10. Unwillingness/inability to provide informed consent 11. Unwillingness to follow study protocol (i.e., predominantly consume drinking water for hydration) |
| Date of first enrolment | 27/01/2025 |
| Date of final enrolment | 27/01/2027 |
Locations
Countries of recruitment
- Germany
Study participating centre
Bad Aibling
83043
Germany
Sponsor information
Hospital/treatment centre
Kolbermoorer Str. 72
Bad Aibling
83043
Germany
| Phone | +49 8061 9030 |
|---|---|
| info@schoen-klinik.de | |
| Website | https://www.schoen-klinik.de/bad-aibling-harthausen |
"ROR" |
https://ror.org/04fr6kc62 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 01/02/2029 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication of study protocol and results in a peer-reviewed journal. |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date. |
Editorial Notes
27/01/2025: Study's existence confirmed by the Ethics Committee of The Faculty of Medicine at Ludwig Maximilians University Munich.
