Effects of drinking water quantity and quality on rehabilitation outcomes in critically ill patients

Drinking water variability effect study in early rehabilitation

Registry ID
ISRCTN55840708
Source registry
ISRCTN
Status
Recruiting
Study type
INTERVENTIONAL
Sponsor
Schön Klinik Bad Aibling
Enrollment
450
Start date
2025-01-27
Completion date
2029-01-27
Last update
2026-08-17

Conditions

Summary

Critical illness

Detailed description

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

Interventions

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

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)

Locations

Related clinical trials

View on source registry