Intravenous Administration of Vitamin B Complex Improves Renal Recovery in Patients With AKI (VIBAKI)

May 16, 2021 updated by: Rolando Claure-Del Granado, Caja Nacional de Salud

The Use of Intravenous Vitamin B Complex Improves Renal Recovery in Patients With Acute Kidney Injury

Animal and human studies have shown that the administration of vitamin B3 (niacin) improves renal ischemia; helping to recover from acute kidney injury (AKI) more effectively; Therefore, its use in patients with AKI could improve short-term outcomes: accelerating the recovery of renal function, reducing the days of hospital stay and costs; as well as reducing the incidence of chronic kidney disease (CKD) or progression of CKD after an episode of AKI.

Our main objective is to determine the usefulness of the administration of vitamin B complex as a treatment for established acute kidney injury and its effect on short and long-term outcomes.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

180

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Rolando Claure-Del Granado, M.D.
  • Phone Number: +591 75908833
  • Email: rclaure@yahoo.com

Study Locations

  • Bolivia
      • Cochabamba, Bolivia
        • Recruiting
        • Hospital Obrero No 2 - C.N.S.
        • Contact:
          • Rolando Claure-Del Granado, M.D.
          • Phone Number: +591 75908833
          • Email: rclaure@yahoo.com
        • Contact:
        • Sub-Investigator:
          • Ariana Torrico, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 98 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients over 18 years of age who meet modified KDIGO criteria for Acute Kidney Injury, based on serum creatinine or urinary volume criteria.

Exclusion Criteria:

  • Patient under 18 years of age
  • Patients with stage G5 chronic kidney disease
  • Patients with chronic kidney replacement therapy.
  • Pregnant women
  • Transplant patients

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vitamin B complex
Randomized patients with AKI to this arm will received during 5 consecutive days IV Vitamin B complex each 12 hours. They will also received the Institution standard of care for AKI.
Drug: Vitamin B Complex

Patients with established AKI will be randomized to received IV vitamin B complex each 1 hours for 5 consecutive days versus placebo.

Every patients will also received Institution standard of care for AKI

Other Names:
  • Placebo
Placebo Comparator: Placebo
Randomized patients with AKI to this arm will received during 5 consecutive days IV placebo each 12 hours. They will also received the Institution standard of care for AKI.
Drug: Vitamin B Complex

Patients with established AKI will be randomized to received IV vitamin B complex each 1 hours for 5 consecutive days versus placebo.

Every patients will also received Institution standard of care for AKI

Other Names:
  • Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete renal recovery
Time Frame: Day 7
Serum creatinine (CrS) level returns to its baseline value or to a lower value.
Day 7

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression to Acute Kidney Disease (AKD)
Time Frame: 1 month
A eGFR < than 60 ml/m/1.73m2
1 month
De novo chronic kidney disease (CKD)
Time Frame: 3 months
An eGFR < than 60 ml/m/1.73m2
3 months
Progression of CKD
Time Frame: 3 months
Patients progresses from a lower KDIGO CKD stage to a higher CKD stage
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Caja Nacional de Salud

Collaborators

International Society of Nephrology

Investigators

  • Principal Investigator: Rolando Claure-Del Granado, M.D., Hospital Obrero No 2 - C.N.S.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2020

Primary Completion (Anticipated)

September 30, 2021

Study Completion (Anticipated)

December 31, 2021

Study Registration Dates

First Submitted

May 16, 2021

First Submitted That Met QC Criteria

May 16, 2021

First Posted (Actual)

May 19, 2021

Study Record Updates

Last Update Posted (Actual)

May 19, 2021

Last Update Submitted That Met QC Criteria

May 16, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VBCNS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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