Clinical trial NCT03877081: Effect of Probiotics and Prebiotics in Renal Function in Septic Acute Kidney Injury Patients
Official title: Effect of Probiotics and Prebiotics in Renal Function in Septic Acute Kidney Injury Patients, Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Acute Kidney Injury
Probiotics
Sepsis
Keywords: Acute kidney injury
Probiotics
Sepsis
Shock
Lead sponsor: Hospital Civil de Guadalajara
Sponsor class: OTHER
First posted: 2019-03-15
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double blind randomized controlled trial
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Serum creatinine
timeFrame: 7 days
Secondary outcomes:
measure: Death
timeFrame: 7 days
measure: Renal replacement therapy
timeFrame: 7 days
measure: Final creatinine
timeFrame: 7 days
measure: Urinary output (final)
timeFrame: 7 days
measure: Shock days
timeFrame: 7 days
measure: Recuperation of basal creatinine
timeFrame: 7 days
measure: Length of hospitalization
timeFrame: 7 days
Other outcomes:
Locations:
city: Guadalajara
country: Mexico
facility: HCG
state: Jalisco
Study officials:
References:
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