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

NCT04893733 | Completed Phase 4

• 1 other identifier: VBCNS
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Kidney Injury

Keywords

Acute Kidney Injury; Vitamin B complex; Creatinine; Proteinuria

Outcome Measures

Primary Outcomes (1)

• Complete renal recovery

  Serum creatinine (CrS) level returns to its baseline value or to a lower value.

  Day 7

Secondary Outcomes (3)

• Progression to Acute Kidney Disease (AKD)

  1 month

• De novo chronic kidney disease (CKD)

  3 months

• Progression of CKD

  3 months

Study Arms (1)

Vitamin B complex

EXPERIMENTAL

Randomized patients with AKI to this arm will received during 5 consecutive days IV Vitamin B complex each 12 hours.

Drug: Vitamin B Complex; Other: STOP AKI protocol

Interventions

Vitamin B Complex DRUG

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

Also known as: Complejo B Vimin

Vitamin B complex

STOP AKI protocol OTHER

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

Vitamin B complex

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients over 18 years of age who meet modified KDIGO criteria for Acute Kidney Injury, based on serum creatinine or urinary volume criteria.

You may not qualify if:

• Patient under 18 years of age
• Patients with stage G5 chronic kidney disease
• Patients with chronic kidney replacement therapy.
• Pregnant women
• Transplant patients

Sponsors & Collaborators

• Caja Nacional de Salud: lead
• International Society of Nephrology: collaborator

Study Sites (1)

Hospital Obrero No 2 - C.N.S.

Cochabamba, Departamento de Cochabamba, 0, Bolivia

Location

MeSH Terms

Conditions

Acute Kidney Injury; Proteinuria

Interventions

Vitamin B Complex

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urination Disorders; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Vitamins; Micronutrients; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Rolando Claure-Del Granado, M.D.

  Hospital Obrero No 2 - C.N.S.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head Division of Nephrology

Study Record Dates

• First Submitted: May 16, 2021
• First Posted: May 19, 2021
• Study Start: September 1, 2020
• Primary Completion: December 30, 2021
• Study Completion: April 30, 2022
• Last Updated: January 30, 2025

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

BO (1)