Critical Illness, Diarrhea
Conditions
Keywords
Bristol Stool Form Scale, Enteral nutrition, Diarrhea, Critically ill
Brief summary
Enteral nutrition-associated diarrhea (ENAD) is one of the most common gastrointestinal complications in critically ill patients receiving enteral nutrition, with a reported incidence of 22.3%-63.1%. Current management lacks a standardized nursing process and relies on individual nurse experience. This study constructs a standardized nursing care pathway driven by the Bristol Stool Form Scale (BSFS) and evaluates, in a prospective randomized controlled design, whether it reduces the severity of ENAD compared with routine ICU care. Eligible mechanically fed ICU patients are randomized 1:1 to the care-pathway group or the routine-care group, observed for 7 days (D1-D7) with a follow-up assessment on D14. The primary endpoint is the Hart diarrhea score over the observation period.
Interventions
BEHAVIORALBSFS-Based Diarrhea Care Pathway
Standardized nursing pathway: stool assessment every 4 h using the Bristol Stool Form Scale, with graded interventions (monitoring frequency, infusion-rate adjustment, formula change, probiotics, perianal skin protection, stepwise feeding resumption) triggered by stool type 5/6/7. Applied to the Care Pathway Group.
OTHERRoutine ICU Enteral Nutrition Care
Standard ICU nursing for enteral nutrition without systematic BSFS assessment.
Sponsors
Tang-Du Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* ICU critically ill patient (APACHE II score ≥15). * Receiving enteral nutrition via nasogastric or nasojejunal tube. * No diarrhea in the 24 hours before enrollment (stool frequency \<3/day or BSFS type \<5). * Written informed consent provided by the patient or legal representative.
Exclusion criteria
* Known allergy to components of the enteral nutrition formula used. * Organic bowel disease such as inflammatory bowel disease or short bowel syndrome. * Pre-existing diarrhea at enrollment (≥3 stools/24 h and BSFS type ≥5). * Severe hepatic insufficiency. * Clostridioides difficile infection or other stool-culture-confirmed infectious diarrhea. * Pregnant or lactating women. * Currently participating in another clinical study. * Any other condition deemed unsuitable by the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Severity of enteral nutrition-associated diarrhea | Daily across the observation period (Day 1 to Day 7) | Diarrhea severity rated by the Hart scoring method; each stool over 24 h is scored and summed for a daily total; total ≥12 indicates diarrhea. Rated by independent blinded assessors. |
| Incidence of ENAD | Day 1 to Day 7 | Proportion meeting the diarrhea definition (Hart ≥12, or ≥3 stools/24 h with BSFS ≥5, or stool ≥500 g/24 h). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of diarrhea | Day 1 to Day 7 | Cumulative hours meeting the diarrhea definition. |
| Incidence and severity of incontinence-associated dermatitis | Day 1 to Day 7 | Proportion developing IAD and severity grade. |
| ICU length of stay | Through study completion, up to Day 14 | Days in ICU. |
Countries
China
Contacts
CONTACTLu Li
CONTACTShuai Qiao
Outcome results
None listed