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临床试验/NCT04893733
NCT04893733已完成4 期

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

Caja Nacional de Salud1 个研究点 分布在 1 个国家目标入组 260 人开始时间: 2020年9月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
260
试验地点
1
主要终点
Complete renal recovery

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None (Participant)

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients over 18 years of age who meet modified KDIGO criteria for Acute Kidney Injury, based on serum creatinine or urinary volume criteria.

排除标准

  • Patient under 18 years of age
  • Patients with stage G5 chronic kidney disease
  • Patients with chronic kidney replacement therapy.
  • Pregnant women
  • Transplant patients

研究组 & 干预措施

Vitamin B complex

Experimental

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

干预措施: Vitamin B Complex (Drug)

Vitamin B complex

Experimental

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

干预措施: STOP AKI protocol (Other)

结局指标

主要结局

Complete renal recovery

时间窗: Day 7

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

次要结局

  • De novo chronic kidney disease (CKD)(3 months)
  • Progression to Acute Kidney Disease (AKD)(1 month)
  • Progression of CKD(3 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Rolando Claure-Del Granado, MD

Head Division of Nephrology

Caja Nacional de Salud

研究点 (1)

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