Acute respiratory distress syndrome complicated by recent upper gastrointestinal bleeding in adult intensive-care patients Respiratory
Conditions
Interventions
This two-centre prospective observational cohort enrolls adults in intensive care with acute respiratory distress syndrome and recent upper gastrointestinal bleeding. Exposure groups are defined by ro
investigators do not randomise or assign care. When nasojejunal feeding is used, placement is performed at the bedside per local protocol with radiographic confirmation, then continuous pump feeding o
Sponsors
Xiamen Science and Technology Bureau Health Guidance Project Research Project
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age =18 years 2. Moderate–to–severe acute respiratory distress syndrome per the Berlin Definition (PaO2/FiO2 =200 mmHg on PEEP =5 cm H2O) 3. Upper gastrointestinal bleeding resolved for =48 hours: no active hematemesis or melena, hemodynamic stability (MAP =65 mmHg without vasopressor escalation), and stable hemoglobin (=1.5 g/dL drop over 24 h without transfusion) 4. Requires enteral nutrition and cannot take orally due to sedation, endotracheal intubation, or dysphagia 5. Anticipated ICU stay =72 hours from enrolment
Exclusion criteria
Exclusion criteria: 1. Ongoing or recurrent gastrointestinal bleeding at screening (new melena, hematemesis, or hemodynamic decompensation requiring transfusion) 2. Allergy or intolerance to short-peptide enteral nutrition components (whey protein hydrolysate, MCT oil) 3. History of major gastrointestinal surgery (e.g., gastrectomy, small-bowel resection) or known mechanical obstruction 4. Glasgow Coma Scale <6 not attributable to sedation (confirmed by RASS scores and medication review) 5. Advanced hepatic encephalopathy (West Haven grade III–IV) 6. Palliative status or a documented plan to withdraw life-sustaining therapy within 48 hours
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum prealbumin (mg/L) measured using routine hospital biochemistry on Day 1 and Day 7; endpoint is the change from Day 1 to Day 7 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Serum albumin (g/L) and total protein (g/dL) measured by routine biochemistry on Days 1 and 7; change Day 1?7 2. C-reactive protein (mg/L) and interleukin-6 (pg/mL) measured by hospital laboratory on Days 1, 4, and 7; change Day 1?7 3. Lymphocyte count (×10?/L) from complete blood count (CBC) on Days 1 and 7; change Day 1?7 4. Nitrogen balance (g/day) calculated from urinary urea nitrogen on Days 1 and 7; change Day 1?7 5. Delivered energy (kcal/kg/day) and protein (g/kg/day) abstracted from ICU nutrition charts daily on Days 1–7; endpoints are mean intake over Days 1–7 and cumulative intake by Day 7 6. Feeding intolerance events (e.g., GRV >500 ml, vomiting, diarrhea, abdominal distension) recorded via standardized checklist every 6 hours through Day 7; endpoint is any event by Day 7 and total events Days 1–7 7. ICU-acquired infections (ventilator-associated pneumonia, bloodstream infection, CLABSI) diagnosed per site protocols to ICU discharge or Day 28; endpoint is any occurrence and time to first event 8. Ventilator-free days (VFDs) to Day 14; endpoint is days alive and free from invasive ventilation between Day 0 and Day 14 (and proportion achieving =14 VFDs) 9. ICU length of stay (days) from enrolment to ICU discharge (capped at Day 28) 10. 28-day all-cause mortality | — |
Countries
China
Contacts
Public ContactXu Dongping
Outcome results
None listed