Acute Kidney Injury, Probiotics, Sepsis
Conditions
Keywords
Acute kidney injury, Probiotics, Sepsis, Shock
Brief summary
Septic acute kidney injury is a condition associated with highly related to inflammatory molecules. Prebiotics and probiotics have shown to improve inflammatory cascade in animal model; In this study, the investigators propose the use of probiotics to improve the clinical evolution of septic acute kidney injury patients.
Detailed description
Acute kidney injury is most commonly caused by sepsis, where endotoxemia and an expanding inflammatory reaction play a key role in its pathogenesis, when this condition is present it is highly related to poor clinical outcomes and higher mortality rates. There is no current specific treatment, and the therapeutic approach is more orientated to complication management. In this study, the investigators propose the use of probiotics to improve the clinical evolution of septic acute kidney injury patients.
Interventions
BIOLOGICALProbiotics
Administration of oral probiotics with 2 doses a day
OTHERPlacebo
Administration of oral placebo with 2 doses a day
Sponsors
Hospital Civil de Guadalajara
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
Double blind randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Sepsis by SOFA * Acute kidney injury by KDIGO
Exclusion criteria
* No presence of sepsis * No presence of AKI * Age below 18 years * Inability or contraindication for oral capsules or probiotics by nasogastric tube
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum creatinine | 7 days | Number of participants with significative reduction of serum creatinine concentration from beginning of the intervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Renal replacement therapy | 7 days | Number of participants that initiate renal replacement therapy |
| Final creatinine | 7 days | Last recorded serum creatinine concentration |
| Urinary output (final) | 7 days | Quantification of urinary output in ml/Kg/hour |
| Death | 7 days | Number of defunctions among the subjects |
| Recuperation of basal creatinine | 7 days | Serum creatinine reduction to 25% from basal creatinine |
| Length of hospitalization | 7 days | Days of hospitalization |
| Shock days | 7 days | Use of vasopressor therapy during hospitalization |
Countries
Mexico
Outcome results
None listed