Critical illness Other
Conditions
Interventions
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
permuted block randomization for pilot, cluster randomization for main study
Sponsors
Schön Klinik Bad Aibling
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
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
Exclusion criteria
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical rehabilitation outcomes measured using Barthel Index Scores on days 1 and 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 spectrophotomet | — |
Countries
Germany
Contacts
Public ContactSimon Göbel
Outcome results
None listed