Ileostomy - Stoma, Intestinal Failure
Conditions
Keywords
Ileostomy, osmolality, natriuresis, dehydration, electrolyte
Brief summary
Quasi-randomized, crossover intervention study, testing osmolality in oral drinks and effect on 6-hours ileostomy output in adult patients with an ileostomy
Detailed description
14 patients with ileostomies were included in a quasi-randomized, crossover intervention study. Each patient ingested between 3-18 different supplements during separate 6-hours intervention periods. Ileostomy output and urine volume will be collected. Outcome measures include faecal wet-weight, urine volume, electrolytes, osmolality, and body composition measured with bioelectrical impedance analysis.
Interventions
DIETARY_SUPPLEMENTwater
oral commercially available supplements
DIETARY_SUPPLEMENTsemi skimmed milk or powerade
oral commercially available supplements
DIETARY_SUPPLEMENTjuice
oral commercially available supplements
Sponsors
University of Aarhus
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Masking description
The patients were randomised to receive either the hypo-osmolar or hyper-osmolar in their first intervention. Microsoft Excel feature RAND (Microsoft version 16) was used to randomize oral supplements. Each supplement was assigned a number. Every time a patient agreed to one or two more intervention periods, two supplements were randomized. One of the primary investigators (JQ) enrolled and randomized supplements to the patients
Intervention model description
This was a single-centre, quasi-randomised cross-over intervention study. The effects of osmolality in oral supplements were investigated using a 3x3 cross-over design.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. age 18 years or higher 2. ileostomy formed at least 8 weeks before enrolment 3. consent to participate
Exclusion criteria
1. pregnancy 2. known chronic kidney disease 3. known diabetes mellitus 4. too long driving distance 5. parenteral nutrition/fluid more than 6 litres per month
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ileostomy output | 6 hours | ileostomy output (wet weight feces grams) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| natriuresis | 6 hours | urine volume (mL) |
| urine sodium | 6 hours | urine sodium mmol |
| urine osmolality | 6 hours | urine osmolality (mmol/kg) |
Countries
Denmark
Outcome results
None listed