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

Study Overview
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Brief Summary
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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.

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

Conditions
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Acute Kidney Injury

Intervention / Treatment
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* Drug: Vitamin B Complex


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vitamin B complex<br>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<br>* 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<br>* Other names: Placebo;|
| Placebo Comparator: Placebo<br>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<br>* 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<br>* Other names: Placebo;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute Kidney Injury, Vitamin B complex, Creatinine, Proteinuria