Influence of symbiotics in the outcome of multiple organ dysfunction syndrome

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2009
INTERVENTION: Intervention group: Priegola Simbiotic Drink®, a pasteurised milk, partially skimmed, with prebiotics (soluble fibre BENEO 1.5% [SYNERGY‐1]) and probiotics (Streptococcus thermophilus, Lactobacillus bulgaricus, Lactobacillus casei, Lactobacillus acidophilus and Bifidobacterium). 100 ml every 12 hours, in the first twelve hours of the organ failures beginning (two or more), for a maximum of seven days. Control group: The control group will not receive the symbiotic. The total duration of treatment in the interventional group will be a maximum of seven days from the organ failure beginning. If the patient is discharged from ICU before seven days (exitus, hospital room), the total number of days with symbiotics will be recorded. The total duration of follow‐up for all arms will be for ICU‐stay and the following will be recorded: 1. Days of ICU stay 2. Days of hospital stay 3. Mortality intra‐ICU 4. Intra‐hospital stay 5. Post‐hospital discharge CONDITION: Multiple organ dysfunction syndrome ; Not Applicable ; Multiple organ failure PRIMARY OUTCOME: 1. Decrease in hospital stay: days of ICU stay and hospital stay will be assessed; 2. Decrease of time and number of injured organs:; 2.1. Time of each organ failure and number of these will be assessed; 2.2. Sequential Organ Failure Assessment (SOFA) classification will be applied to define the dysfunction of each organ SECONDARY OUTCOME: 1. Decrease of 30 day‐mortality: assessed exitus (yes/no) inside UCI, post‐hospital discharge and 30 days after hospital discharge; 2. Decrease of the bloodstream infections, taking into account only the samples confirmed by the microbiology laboratory; 3. Decrease of the nosocomial pneumonia, assessing the nosocomial pneumonia diagnosed by the attending clinician; 4. Improvement of tolerance to enteral nutrition: the number of days the patient can feed with enteral nutrition only 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.
Epistemonikos ID: 25720a5688ef3646a217b4fb01ea9f12da54bf0e
First added on: Aug 22, 2024