Influence of symbiotics in the outcome of multiple organ dysfunction syndrome
| ISRCTN | ISRCTN22361317 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN22361317 |
| Secondary identifying numbers | FISCAM: PI-2007/13 |
- Submission date
- 09/12/2008
- Registration date
- 16/01/2009
- Last edited
- 16/01/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Ismael López de Toro Martín-Consuegra
Scientific
Scientific
Avda. Barber, 30
Intensive Care Unit
Hospital V. de la Salud
Toledo
45005
Spain
| Phone | +34 925 26 92 37 |
|---|---|
| ilopez@sescam.jccm.es |
Study information
| Study design | Single-centre prospective aleatorised randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Influence of symbiotics in the outcome of multiple organ dysfunction syndrome: a prospective, aleatorised, randomised controlled trial |
| Study objectives | Bacterial translocation in the gastrointestinal tract is a key physiopathological process in the development of some critically ill patient's injuries, such as nosocomial pneumonia or multiple organ dysfunction syndrome. The bacterial overgrowth increases gut wall permeability, with associated bacterial translocation into the portal circulation leading to the development of distant septic foci. Different procedures have been used to eliminate the potentially pathogenic organisms for example: selective digestive decontamination with prophylactic administration of topic and intravenous antibiotic. An alternative approach is to introduce non-pathogenic bacteria which can replace the bacteria eliminated by antibiotic therapy and on the other hand, competitively inhibit colonisation by pathogenic strains. Our working hypothesis is based on non-pathogenic bacteria from ICU-admission of the patient with at least two organ failures improving the course of patient-ICU, ICU-stay and hospital stay and could also have a beneficial effect on new individual organ failures. We think the administration of non-pathogenic bacteria will keep the normal flora in the gastrointestinal tract and decrease the multiple organ dysfunction syndrome incidence in ICU-patients. |
| Ethics approval(s) | Clinical Investigation Ethics Committee of Hospital "Virgen de la Salud" (Toledo, Spain) gave approval on 12th January 2008 |
| Health condition(s) or problem(s) studied | Multiple organ dysfunction syndrome |
| 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 |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Priegola Simbiotic Drink® |
| Primary outcome measure | 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 measures | 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 |
| Overall study start date | 01/12/2008 |
| Completion date | 01/12/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 175 patients by group (total: 350) |
| Key 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. |
| Key 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 |
| Date of first enrolment | 01/12/2008 |
| Date of final enrolment | 01/12/2009 |
Locations
Countries of recruitment
- Spain
Study participating centre
Avda. Barber, 30
Toledo
45005
Spain
45005
Spain
Sponsor information
Hospital Virgen de la Salud (Spain)
Hospital/treatment centre
Hospital/treatment centre
Intensive Care Unit
Avda. Barber, 30
Toledo
45005
Spain
| Phone | +34 925 26 92 37 |
|---|---|
| ilopez@sescam.jccm.es | |
"ROR" |
https://ror.org/0289cxp23 |
Funders
Funder type
Research organisation
FISCAM Health Research Foundation (Spain) (ref.: PI-2007/13)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
