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

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ClinicalTrials.gov Identifier: NCT03877081
Recruitment Status : Recruiting
First Posted : March 15, 2019
Last Update Posted : March 15, 2019
Sponsor:
Information provided by (Responsible Party):
Jonathan Samuel Chavez Iñiguez, 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.

Condition or disease Intervention/treatment Phase
Acute Kidney Injury Probiotics Sepsis Biological: Probiotics Other: Placebo Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Double blind randomized controlled trial
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Probiotics and Prebiotics in Renal Function in Septic Acute Kidney Injury Patients, Randomized Control Trial
Actual Study Start Date : January 4, 2019
Estimated Primary Completion Date : January 4, 2020
Estimated Study Completion Date : January 4, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Tests

Arm Intervention/treatment
Experimental: Probiotics. Intervention patients
This patients will receive 2 doses of oral probiotics a day, for seven days
Biological: Probiotics
Administration of oral probiotics with 2 doses a day

Placebo Comparator: Placebo group
This patients will receive 2 doses of oral placebo a day, for seven days
Other: Placebo
Administration of oral placebo with 2 doses a day




Primary Outcome Measures :
  1. Serum creatinine [ Time Frame: 7 days ]
    Number of participants with significative reduction of serum creatinine concentration from beginning of the intervention


Secondary Outcome Measures :
  1. Death [ Time Frame: 7 days ]
    Number of defunctions among the subjects

  2. Renal replacement therapy [ Time Frame: 7 days ]
    Number of participants that initiate renal replacement therapy

  3. Final creatinine [ Time Frame: 7 days ]
    Last recorded serum creatinine concentration

  4. Urinary output (final) [ Time Frame: 7 days ]
    Quantification of urinary output in ml/Kg/hour

  5. Shock days [ Time Frame: 7 days ]
    Use of vasopressor therapy during hospitalization

  6. Recuperation of basal creatinine [ Time Frame: 7 days ]
    Serum creatinine reduction to 25% from basal creatinine

  7. Length of hospitalization [ Time Frame: 7 days ]
    Days of hospitalization



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03877081


Locations
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Mexico
HCG Recruiting
Guadalajara, Jalisco, Mexico, 44240
Contact: Jonathan Samuel Chavez    3313299609    jonarchi_10@hotmail.com   
Principal Investigator: Jonathan S Chavez-Iniguez, MD         
Sub-Investigator: Guillermo Garcia-Garcia, MD         
Sponsors and Collaborators
Hospital Civil de Guadalajara

Publications:

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Responsible Party: Jonathan Samuel Chavez Iñiguez, MD, Nephrologist, Principal investigator, Hospital Civil de Guadalajara
ClinicalTrials.gov Identifier: NCT03877081     History of Changes
Other Study ID Numbers: AKI and Probiotics
First Posted: March 15, 2019    Key Record Dates
Last Update Posted: March 15, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Jonathan Samuel Chavez Iñiguez, Hospital Civil de Guadalajara:
Acute kidney injury
Probiotics
Sepsis
Shock

Additional relevant MeSH terms:
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Wounds and Injuries
Sepsis
Acute Kidney Injury
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Renal Insufficiency
Kidney Diseases
Urologic Diseases