A PROSPECTIVE STUDY ON THE EFFICACY OF BEETROOT JUICE IN PREVENTING CONTRAST-INDUCED NEPHROPATHY IN CKD PATIENTS UNDERGOING ANGIOGRAM/PCI IN THE INDIAN POPULATION
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Incidence of CIN
研究概览
简要总结
Estimate the amount of nitrate present in an average beetroot and then adjust the average concentration required. The patients are selected according to the inclusion and exclusion criterion. In Test group patients started on beetroot juice day before procedure up to day 3 and Hydration regimen as recommended by ACR or EACTS. In Control group Hydration Regimen as recommended by ACR or EACTS. No dietary modifications done and restrict all nitrate containing dietary source. Risk factor questionnaire (Chyoke adapted) and Quality of life assessment (EQ 5D) assessed at Day 1 and Day 3. Iodine restricted diet for both groups. CRP is monitored from Day 1 to 5. At 3 hour Troponin and CRP determined. At 12 hour after the procedure serum creatinine and NGAL tested.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient undergoing coronary angiography or PCI for NSTE-ACS
- •Requirement for CIN prophylaxis as per Barts Heart Centre Criteria for CIN prophylaxis:.
- •eGFR less than 60ml/min or.
- •2 of the following: diabetes, liver failure(cirrhosis), age more than 70 years, exposure to contrast in last 7 days, heart failure (LVEF less than 40%), concomitant renally active drugs (ACEI, ARB, NSAIDs, aminoglycosides, diuretics)
- •Age more than or equal to 18
- •Patients able and willing to give their written informed consent.
排除标准
- •ST segment elevation myocardial infarction undergoing Primary PCI
- •Patients with eGFR less than 20 ml/min or on renal replacement therapy.
- •Subjects presenting with cardiogenic shock(systolic blood pressure less than 80mmHg for more than 30 min or requiring inotropes or emergency intra aortic balloon pump for hypotension treatment) or cardiopulmonary resuscitation.
- •Current life-threatening condition other than vascular disease that may prevent a subject completing the study.
- •Use of an investigational devise or investigational drug within 30days or 5 half-life (whichever is the longer) preceding the first dose of study medication.
- •Severe acute infection.
- •This will be tested by urine HcG measurement.
- •Systemic autoimmune disease such as rheumatoid arthritis or other conditions known to be associated with chronic inflammation such as inflammatory bowel disease.
- •Patients who have donated more than 500ml of blood within 56 days prior to study medication administration.
- •A history of chronic viral hepatitis(including presence of hepatitis B surface antigen or Hepatitis C antibody or other chronic hepatic disorder) or HIV.
- •Patients unable to take oral feeds.
- •Any Inclusion Criterion not met.
结局指标
主要结局
Incidence of CIN
时间窗: Feb 2025 to April 2025
次要结局
- Adverse events(5-7 days)
研究者
DR RAJESH THACHATHODIYIL
AMRITA INSTITUTE OF MEDICAL SCIENCES AND RESEARCH CENTRE