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

Acute Kidney Injury Clinical Trial

— VIBAKI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04893733
• Other study ID #: VBCNS
• Status: Recruiting
• Phase: Phase 4
• Start date: September 1, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: May 2021
• Source: Caja Nacional de Salud
• Contact: Rolando Claure-Del Granado, M.D.
• Phone: +591 75908833
• Email: rclaure[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: December 31, 2021
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury

Intervention

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

Locations

Country	Name	City	State
Bolivia	Hospital Obrero No 2 - C.N.S.	Cochabamba

Sponsors (2)

Lead Sponsor	Collaborator
Caja Nacional de Salud	International Society of Nephrology

Country where clinical trial is conducted

Bolivia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete renal recovery	Serum creatinine (CrS) level returns to its baseline value or to a lower value.	Day 7
Secondary	Progression to Acute Kidney Disease (AKD)	A eGFR < than 60 ml/m/1.73m2	1 month
Secondary	De novo chronic kidney disease (CKD)	An eGFR < than 60 ml/m/1.73m2	3 months
Secondary	Progression of CKD	Patients progresses from a lower KDIGO CKD stage to a higher CKD stage	3 months