跳至主要内容
临床试验/NCT03238391
NCT03238391Unknown不适用

Ischemic Preconditioning for Prevention of Contrast Nephropathy in The Emergency Department: Randomised, Double Blind Clinical Trial

Derince Training and Research Hospital0 个研究点目标入组 350 人开始时间: 2017年8月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
350
主要终点
Percentage of Participants developing contrast-induced nephropathy

研究概览

简要总结

The purpose of this study is to demonstrate the effectiveness of ischemic preconditioning in the emergency department to prevent contrast induced nephropathy

详细描述

The research will be conducted of emergency medicine department in The Derince Training and Research Hospital. Patients ages 18 and older, who will be received contrast enhanced CT scan in the emergency medicine department will be included to the study. Patients will be excluded from the study if The Mehran Risk Score is under 6 points. The Mehran Risk Score is a scoring system for prediction of contrast-induced nephropathy. This CIN (Contrast induced nephropathy) risk stratification score based on 8 variables. The variables included in the CIN risk score are: 1) patient-related characteristics (i.e., age >75 years, diabetes mellitus, chronic congestive heart failure, or admission with acute pulmonary edema, hypotension, anemia, and chronic kidney disease); and 2) procedure related characteristics (i.e., the use of elective IABP (Intra aortic balloon pump) or increasing volumes of contrast media). It is categorized into 4 groups according to MRS (Mehran Risk Score) (low-risk: 5 (7.5%); medium-risk: 6-10 (14%); high-risk: 11-16 (26.1%); and very high-risk: 16 (57.3%).Normal salin at a rate of 3 mL/kg/hour per 1 hour before contrast agents exposure followed by 1 mL/kg/hour for 6 hours after the procedure is administered whose Mehran risk score is greater than 6 in our daily practice. Patients with risk factors for CIN are recommended about the necessity of follow-up care with their physicians within 48-72 hours. Patients with low risk of contrast induced nephropathy, previous allergic reactions to contrast material, hemodynamically unstable and require excessive fluid resuscitation, undergoing surgical procedures, require renal-replacement therapy, who refuse to participate the study will be excluded. All of the emergency medicine physicians will be informed of the study. Participants were randomly assigned into two groups with a 1:1 allocation following simple randomization procedures by a program (www.randomization.com) generating an online random number. All participating patients will receive the standard hydration schedule as mentioned before. Patients in the study group will receive ischemia and reperfusion of the arm by inflating a blood pressure cuff around the arm at 50 mmHg above the systolic blood pressure for 5 minutes, followed by 5 minutes of reperfusion and this cycle will be repeated three times. Patients in sham group, will receive ischemia and reperfusion of the arm by inflating a blood pressure cuff around the arm at 10 mmHg below the diastolic blood pressure for 5 minutes, followed by 5 minutes of reperfusion and this cycle will be repeated three times. The allocation sequence will be concealed from the researchers and participants in sealed, sequentially numbered envelopes. Envelopes will be opened by the nurse who will administer the protocol. Less than 100 mL of nonionic, hypoosmolar contrast agent will be injected in all CT scans.All of the participants will be recommended about the necessity of follow-up care with their physicians within 48-72 hours. Participants will be called 72 hours after the treatment. Patients who are diagnosed with CIN will be followed for one month to see whether they will develop renal failure requiring renal replacement therapy. After 72 hours the laboratory results will be recorded by the researchers.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Investigator)

入排标准

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

入选标准

  • Participants, older than 18 years old and received contrast enhanced CT scan in the emergency medicine department
  • The Mehran Risk Score is greater than 5 points

排除标准

  • The Mehran Risk Score is under 6 points
  • Participants who doesn't want to enroll the study

研究组 & 干预措施

Study group

Experimental

Patients will receive ischemia and reperfusion of the arm by inflating a blood pressure cuff around the arm at 50 mmHg above the systolic blood pressure for 5 minutes, followed by 5 minutes of reperfusion and this cycle will be repeated three times

干预措施: Ischemic preconditioning (Procedure)

Sham group

Sham Comparator

Patients will receive ischemia and reperfusion of the arm by inflating a blood pressure cuff around the arm at 10 mmHg below the diastolic blood pressure for 5 minutes, followed by 5 minutes of reperfusion and this cycle will be repeated three times

干预措施: Ischemic preconditioning (Procedure)

结局指标

主要结局

Percentage of Participants developing contrast-induced nephropathy

时间窗: 48 to 72 hours

%25 increase or a greater than 0,5 mg/dl increase in the serum creatinine level, 48 to 72 hours after the administration of contrast agent compared with the baseline creatinine measurement

次要结局

  • renal replacement theraphy(1 month)

研究者

发起方
Derince Training and Research Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yavuz Yiğit

Emergency medicine specialist

Derince Training and Research Hospital

相似试验