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| Name | Class |
|---|---|
| International Society of Nephrology | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin B complex | Experimental | Randomized patients with AKI to this arm will received during 5 consecutive days IV Vitamin B complex each 12 hours. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Complete renal recovery | Serum creatinine (CrS) level returns to its baseline value or to a lower value. | Day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Progression to Acute Kidney Disease (AKD) | A eGFR < than 60 ml/m/1.73m2 | 1 month |
| De novo chronic kidney disease (CKD) | An eGFR < than 60 ml/m/1.73m2 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rolando Claure-Del Granado, M.D. | Hospital Obrero No 2 - C.N.S. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Obrero No 2 - C.N.S. | Cochabamba | Cochabamba | 0 | Bolivia |
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| ID | Term |
|---|---|
| D058186 | Acute Kidney Injury |
| D011507 | Proteinuria |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D014803 | Vitamin B Complex |
| ID | Term |
|---|---|
| D014815 | Vitamins |
| D018977 | Micronutrients |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
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|
| 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 |
|
| 3 months |
| Progression of CKD | Patients progresses from a lower KDIGO CKD stage to a higher CKD stage | 3 months |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D014555 | Urination Disorders |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020164 |
| Chemical Actions and Uses |