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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04893733
Acronym
VIBAKI
Enrollment
260
Registered
2021-05-19
Start date
2020-09-01
Completion date
2022-04-30
Last updated
2025-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Kidney Injury

Keywords

Acute Kidney Injury, Vitamin B complex, Creatinine, Proteinuria

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.

Interventions

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

OTHERSTOP AKI protocol

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

Sponsors

International Society of Nephrology
CollaboratorOTHER
Caja Nacional de Salud
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Complete renal recoveryDay 7Serum creatinine (CrS) level returns to its baseline value or to a lower value.

Secondary

MeasureTime frameDescription
Progression to Acute Kidney Disease (AKD)1 monthA eGFR \< than 60 ml/m/1.73m2
De novo chronic kidney disease (CKD)3 monthsAn eGFR \< than 60 ml/m/1.73m2
Progression of CKD3 monthsPatients progresses from a lower KDIGO CKD stage to a higher CKD stage

Countries

Bolivia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026