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

Phase 3

• Conditions: Probiotics; Sepsis; Acute Kidney Injury
• Interventions: Biological: Probiotics; Other: Placebo

• Registration Number: NCT03877081
• Lead Sponsor: Hospital Civil de Guadalajara

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.

Study Timeline

• Study Start: 2019-01-04
• Study First Submitted: 2019-03-12
• Study First Submitted QC: 2019-03-14
• Study First Posted: 2019-03-15
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-24
• Last Update Posted: 2021-08-25
• Primary Completion: 2022-09-04
• Study Completion: 2023-02-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Probiotics. Intervention patients	Probiotics	This patients will receive 2 doses of oral probiotics a day, for seven days
Placebo group	Placebo	This patients will receive 2 doses of oral placebo a day, for seven days

Primary Outcome Measures

Name	Time	Method
Serum creatinine	7 days	Number of participants with significative reduction of serum creatinine concentration from beginning of the intervention

Secondary Outcome Measures

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

Trial Locations

Locations (1)

HCG; 🇲🇽 Guadalajara, Jalisco, Mexico