Effect of Probiotics and Prebiotics in Renal Function in Septic Acute Kidney Injury Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of Probiotics and Prebiotics in Renal Function in Septic Acute Kidney Injury Patients, Randomized Control Trial

Conditions
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Acute Kidney Injury, Probiotics, Sepsis

Intervention / Treatment
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* Biological: Probiotics
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Double blind randomized controlled trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Probiotics. Intervention patients<br>This patients will receive 2 doses of oral probiotics a day, for seven days | Biological: Probiotics<br>* Administration of oral probiotics with 2 doses a day<br>|
| Placebo Comparator: Placebo group<br>This patients will receive 2 doses of oral placebo a day, for seven days | Other: Placebo<br>* Administration of oral placebo with 2 doses a day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum creatinine | Number of participants with significative reduction of serum creatinine concentration from beginning of the intervention | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death | Number of defunctions among the subjects | 7 days | 
| Renal replacement therapy | Number of participants that initiate renal replacement therapy | 7 days | 
| Final creatinine | Last recorded serum creatinine concentration | 7 days | 
| Urinary output (final) | Quantification of urinary output in ml/Kg/hour | 7 days | 
| Shock days | Use of vasopressor therapy during hospitalization | 7 days | 
| Recuperation of basal creatinine | Serum creatinine reduction to 25% from basal creatinine | 7 days | 
| Length of hospitalization | Days of hospitalization | 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute kidney injury, Probiotics, Sepsis, Shock