The Use of Intravenous Vitamin B Complex Improves Renal Recovery in Patients with Acute Kidney Injury
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Caja Nacional de Salud
- Enrollment
- 260
- Locations
- 1
- Primary Endpoint
- Complete renal recovery
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None (Participant)
Eligibility Criteria
- Ages
- 18 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Vitamin B complex
Randomized patients with AKI to this arm will received during 5 consecutive days IV Vitamin B complex each 12 hours.
Intervention: Vitamin B Complex (Drug)
Vitamin B complex
Randomized patients with AKI to this arm will received during 5 consecutive days IV Vitamin B complex each 12 hours.
Intervention: STOP AKI protocol (Other)
Outcomes
Primary Outcomes
Complete renal recovery
Time Frame: Day 7
Serum creatinine (CrS) level returns to its baseline value or to a lower value.
Secondary Outcomes
- De novo chronic kidney disease (CKD)(3 months)
- Progression to Acute Kidney Disease (AKD)(1 month)
- Progression of CKD(3 months)
Investigators
Rolando Claure-Del Granado, MD
Head Division of Nephrology
Caja Nacional de Salud