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

NCT ID: NCT04893733

Last Updated: 2025-01-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 260 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-01
• Study Completion Date: 2022-04-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Vitamin B complex

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

Group Type: EXPERIMENTAL

Vitamin B Complex

Intervention Type: 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

STOP AKI protocol

Intervention Type: 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

Interventions

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

Intervention Type: DRUG

STOP 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

Intervention Type: OTHER

Other Intervention Names

Complejo B Vimin

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

International Society of Nephrology

OTHER

Sponsor Role: collaborator

Caja Nacional de Salud

OTHER

Sponsor Role: lead

Responsible Party

Rolando Claure-Del Granado, MD

Head Division of Nephrology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rolando Claure-Del Granado, M.D.

Role: PRINCIPAL_INVESTIGATOR

Hospital Obrero No 2 - C.N.S.

Locations

Hospital Obrero No 2 - C.N.S.

Cochabamba, Departamento de Cochabamba, Bolivia

Countries

Bolivia

Other Identifiers

VBCNS

Identifier Type: -

Identifier Source: org_study_id