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

Phase 4

Completed

• Conditions: Acute Kidney Injury
• Interventions: Drug: Vitamin B Complex; Other: STOP AKI protocol

• Registration Number: NCT04893733
• Lead Sponsor: Caja Nacional de Salud

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-09-01
• Study First Submitted: 2021-05-16
• Study First Submitted QC: 2021-05-16
• Study First Posted: 2021-05-19
• Primary Completion: 2021-12-30
• Study Completion: 2022-04-30
• Status Verified: 2022-07
• Last Update Submitted: 2025-01-28
• Last Update Posted: 2025-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 260

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Vitamin B complex	Vitamin B Complex	Randomized patients with AKI to this arm will received during 5 consecutive days IV Vitamin B complex each 12 hours.
Vitamin B complex	STOP AKI protocol	Randomized patients with AKI to this arm will received during 5 consecutive days IV Vitamin B complex each 12 hours.

Primary Outcome Measures

Name	Time	Method
Complete renal recovery	Day 7	Serum creatinine (CrS) level returns to its baseline value or to a lower value.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hospital Obrero No 2 - C.N.S.; 🇧🇴 Cochabamba, Bolivia