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

Primary Purpose

Acute Kidney Injury

Status
Unknown status
Phase
Phase 4
Locations
Bolivia
Study Type
Interventional
Intervention
Vitamin B Complex
Sponsored by
Caja Nacional de Salud
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Kidney Injury focused on measuring Acute Kidney Injury, Vitamin B complex, Creatinine, Proteinuria

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital Obrero No 2 - C.N.S.Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Vitamin B complex

Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Complete renal recovery
Serum creatinine (CrS) level returns to its baseline value or to a lower value.

Secondary Outcome Measures

Progression to Acute Kidney Disease (AKD)
A eGFR < than 60 ml/m/1.73m2
De novo chronic kidney disease (CKD)
An eGFR < than 60 ml/m/1.73m2
Progression of CKD
Patients progresses from a lower KDIGO CKD stage to a higher CKD stage

Full Information

First Posted
May 16, 2021
Last Updated
May 16, 2021
Sponsor
Caja Nacional de Salud
Collaborators
International Society of Nephrology
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1. Study Identification

Unique Protocol Identification Number
NCT04893733
Brief Title
Intravenous Administration of Vitamin B Complex Improves Renal Recovery in Patients With AKI
Acronym
VIBAKI
Official Title
The Use of Intravenous Vitamin B Complex Improves Renal Recovery in Patients With Acute Kidney Injury
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
September 30, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Caja Nacional de Salud
Collaborators
International Society of Nephrology

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Kidney Injury
Keywords
Acute Kidney Injury, Vitamin B complex, Creatinine, Proteinuria

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Vitamin B complex
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Vitamin B Complex
Other Intervention Name(s)
Placebo
Intervention Description
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
Primary Outcome Measure Information:
Title
Complete renal recovery
Description
Serum creatinine (CrS) level returns to its baseline value or to a lower value.
Time Frame
Day 7
Secondary Outcome Measure Information:
Title
Progression to Acute Kidney Disease (AKD)
Description
A eGFR < than 60 ml/m/1.73m2
Time Frame
1 month
Title
De novo chronic kidney disease (CKD)
Description
An eGFR < than 60 ml/m/1.73m2
Time Frame
3 months
Title
Progression of CKD
Description
Patients progresses from a lower KDIGO CKD stage to a higher CKD stage
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rolando Claure-Del Granado, M.D.
Phone
+591 75908833
Email
rclaure@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rolando Claure-Del Granado, M.D.
Organizational Affiliation
Hospital Obrero No 2 - C.N.S.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Obrero No 2 - C.N.S.
City
Cochabamba
ZIP/Postal Code
0
Country
Bolivia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rolando Claure-Del Granado, M.D.
Phone
+591 75908833
Email
rclaure@yahoo.com
First Name & Middle Initial & Last Name & Degree
Ariana Torrico, M.D.
Phone
+591 61677773
Email
ari-torrico13@hotmail.com
First Name & Middle Initial & Last Name & Degree
Ariana Torrico, M.D.

12. IPD Sharing Statement

Plan to Share IPD
No

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

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