A Phase 4 interventional study of Vitamin B Complex and STOP AKI protocol in Acute Kidney Injury, sponsored by Caja Nacional de Salud. Completed at 1 site in Bolivia. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2025-01-30.
Sponsored by Caja Nacional de Salud · Phase 4, Interventional, and Treatment
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.
1,691 studies on the registry are indexed under Acute Kidney Injury; 395 are open to participants now.
This study's enrollment of 260 is above the median of 100 across 817 interventional studies indexed under Acute Kidney Injury.
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Exclusion Criteria:
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
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
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
Complete renal recovery
Serum creatinine (CrS) level returns to its baseline value or to a lower value.
Time frame: Day 7
Progression to Acute Kidney Disease (AKD)
A eGFR \< than 60 ml/m/1.73m2
Time frame: 1 month
De novo chronic kidney disease (CKD)
An eGFR \< than 60 ml/m/1.73m2
Time frame: 3 months
Progression of CKD
Patients progresses from a lower KDIGO CKD stage to a higher CKD stage
Time frame: 3 months
Plan to share: No
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This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Vitamin B Complex