Influence of symbiotics in the outcome of multiple organ dysfunction syndrome
Completed
- Conditions
- Multiple organ dysfunction syndromeNot ApplicableMultiple organ failure
- Registration Number
- ISRCTN22361317
- Lead Sponsor
- Hospital Virgen de la Salud (Spain)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 350
Inclusion Criteria
Adults (greater than 18 years, either sex) with two or more organ failures without exclusion criteria. The informed consent will be obtained from patients or their relatives.
Exclusion Criteria
1. Less than 18 years
2. Pregnant
3. Severe immunodepression (neutropenia less than 500/ml)
4. Inability to receive symbiotic administration
5. Pancreatitis
6. Symbiotics allergy
7. Death in the first 12 hours
8. Patients taking part in another clinical trial
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Decrease in hospital stay: days of ICU stay and hospital stay will be assessed<br>2. Decrease of time and number of injured organs:<br>2.1. Time of each organ failure and number of these will be assessed<br>2.2. Sequential Organ Failure Assessment (SOFA) classification will be applied to define the dysfunction of each organ
- Secondary Outcome Measures
Name Time Method 1. Decrease of 30 day-mortality: assessed exitus (yes/no) inside UCI, post-hospital discharge and 30 days after hospital discharge<br>2. Decrease of the bloodstream infections, taking into account only the samples confirmed by the microbiology laboratory<br>3. Decrease of the nosocomial pneumonia, assessing the nosocomial pneumonia diagnosed by the attending clinician<br>4. Improvement of tolerance to enteral nutrition: the number of days the patient can feed with enteral nutrition only