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

Sepsis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03877081
• Other study ID #: AKI and Probiotics
• Status: Recruiting
• Phase: Phase 3
• Start date: January 4, 2019
• Est. completion date: February 4, 2023

Study information

• Verified date: August 2021
• Source: Hospital Civil de Guadalajara
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: February 4, 2023
• Est. primary completion date: September 4, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Probiotics
• Sepsis
• Wounds and Injuries

Intervention

Biological:
• Probiotics
Administration of oral probiotics with 2 doses a day

Other:
• Placebo
Administration of oral placebo with 2 doses a day

Locations

Country	Name	City	State
Mexico	HCG	Guadalajara	Jalisco

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Civil de Guadalajara

Country where clinical trial is conducted

Mexico, 

References & Publications (37)

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* Note: There are 37 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum creatinine	Number of participants with significative reduction of serum creatinine concentration from beginning of the intervention	7 days
Secondary	Death	Number of defunctions among the subjects	7 days
Secondary	Renal replacement therapy	Number of participants that initiate renal replacement therapy	7 days
Secondary	Final creatinine	Last recorded serum creatinine concentration	7 days
Secondary	Urinary output (final)	Quantification of urinary output in ml/Kg/hour	7 days
Secondary	Shock days	Use of vasopressor therapy during hospitalization	7 days
Secondary	Recuperation of basal creatinine	Serum creatinine reduction to 25% from basal creatinine	7 days
Secondary	Length of hospitalization	Days of hospitalization	7 days