Skip to main content
OpenTrials
Completed

NCT Number: NCT04893733

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital Obrero No 2 - C.N.S.

Cochabamba, Bolivia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: Complejo B Vimin

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

Primary outcomes

  1. Complete renal recovery

    Time frame: Day 7

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

Secondary outcomes

  1. Progression to Acute Kidney Disease (AKD)

    Time frame: 1 month

    A eGFR < than 60 ml/m/1.73m2

  2. De novo chronic kidney disease (CKD)

    Time frame: 3 months

    An eGFR < than 60 ml/m/1.73m2

  3. Progression of CKD

    Time frame: 3 months

    Patients progresses from a lower KDIGO CKD stage to a higher CKD stage

Sponsors and collaborators

Lead sponsor

Caja Nacional de Salud

Other

Collaborators

  • International Society of Nephrology

Registry information

Official study title

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

Acronym: VIBAKI

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
May 19, 2021
Registry last updated
Jan 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.