A single centre nested cohort study investigating the effect of using 0.9 % saline or Plasmalyte 148 as primary fluid therapy on gastrointestinal complications in mechanically ventilated patients with nasogastric enteral nutritio
Phase 4
Active, not recruiting
- Conditions
- Critical IllnessMechanical VentilationOral and Gastrointestinal - Normal oral and gastrointestinal development and functionDiet and Nutrition - Other diet and nutrition disorders
- Registration Number
- ACTRN12614000269639
- Lead Sponsor
- Medical Research Institute of New Zealand
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 200
Inclusion Criteria
Adult patients > 18 years.
Patients who are expected to be mechanically ventilated for greater than 48 hours and receiving NG enteral nutrition.
Exclusion Criteria
Patients who are <18 years in age.
Patients expected to require mechanical ventilation for less than 48 hours.
Patients mechanically ventilated and not receiving enteral nutrition.
Patients receiving duodenal or jejunal feeding.
Patients who are expected to require renal replacement therapy within six hours of ICU admission.
Patients who are usually on dialysis for end stage renal failure.
Patients who are admitted to the ICU solely for consideration of organ donation or for palliative care.
Patients previously enrolled in the SPLIT trial.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Composite outcome of proportion of patients with gastrointestinal complications :<br>High gastric residual volume (Gastric residual volume > 500 ml)<br>Patients with vomiting<br>Patients with diarrhoea <br>Method to assess outcome- review from patients clinical records. [Monitored daily throughout duration of mechanical ventilation of each participant]
- Secondary Outcome Measures
Name Time Method Diet volume ratio (volume received/ volume prescribed) [At 48 hours after commencement of nasogastric feeding ];Duration of nasogastric (NG) enteral feeding <br>Method to assess outcome - Review of patient records[Monitored daily throughout duration of ICU stay of each participant];Cause of NG enteral feeding finalization <br>Method to assess outcome - Review of patient records[Monitored daily throughout duration of ICU stay of each participant];Days of mechanical ventilation <br>Method to assess outcome - Review of patient records[Monitored daily throughout duration of ICU stay of each participant];ICU length of stay [At discharge from ICU];ICU re-admission<br>Method of assess outcome - review of patient records[At discharge from hospital];Hospital length of stay[At discharge from hospital];In-Hospital mortality [Duration of Hospital stay]