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

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: Completed
• Conditions: Acute Kidney Injury
• Intervention / Treatment: Drug: Vitamin B Complex; Other: STOP AKI protocol

• Study Type: Interventional
• Enrollment (Actual): 260
• Phase: Phase 4

Contacts and Locations

Study Locations

• Bolivia
  • Cochabamba, Bolivia
    • Hospital Obrero No 2 - C.N.S.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 96 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

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.

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: Complejo B Vimin; Other: STOP AKI protocol; STOP AKI protocols includes: S: identify and treat sepsis. Standard measures should be followed to decrease the risk of infection. Close surveillance to identify early signs of infection with appropriate treatment T: avoid nephrotoxins. Avoidance of drugs harmful to the kidneys (e.g. NSAIDs, gentamicin) Care with intravenous iodinated contrast O: optimize blood pressure and optimize volume status. Avoid dehydration e.g. confused patient. Treat hypovolaemia promptly. Consider with-holding patient anti-hypertensives/diuretics until assessed after major surgery or if patient develops sepsis/hypovolemia P: Prevent harm. Identify the cause promptly and manage appropriately to prevent progression. Prevent complications by instituting prompt therapy. Identify drugs excreted through the kidneys and adjust drug doses promptly if AKI develops. Review fluid management plans to prevent inadequate or excessive intravenous fluid administration

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• 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

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Actual): December 30, 2021
• Study Completion (Actual): April 30, 2022

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): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 28, 2025
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Proteinuria; Acute Kidney Injury; Creatinine; Vitamin B complex
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Renal Insufficiency; Acute Kidney Injury; Physiological Effects of Drugs; Micronutrients; Vitamins; Hematinics; Folic Acid; Vitamin B Complex
• 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