跳至主要内容
临床试验/NCT02711332
NCT02711332已完成不适用

Investigating the Influence of Haemolysis on the Potassium Concentration After Capillary Blood Sampling

Medical University of Graz0 个研究点目标入组 22 人开始时间: 2015年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
22
主要终点
Measured potassium concentration in capillary blood tests compared to venous blood tests.

研究概览

简要总结

This is an open, single-centre trial investigating the impact of haemolysis after capillary blood collection to the measured potassium concentration in Plasma healthy subjects. Each subject will have four capillary blood collections on different fingers. Two on the right and two on the left hand. Additionally as a reference a venous blood collection will be conducted.

详细描述

K@Home_1 a working package of the FFG project "K@Home - potassium home monitoring for patients with heart- and kidney insufficiency". In the project K@Home a potassium measuring system serveable by the patients even of the home monitoring should be developed.

Aim from K@Home is to allow an everyday home monitoring of the potassium value by the development of potassium-test stripe, like with the diabetes patients who supervise their blood sugar level by measurements with glucose-test stripe from a drop of capillary blood from the finger berry and with it the emergencies and hospital admissions to reduce or to prevent. It is fact that haemolysis has a strong influence on the measured potassium concentration. It is likely that by using capillary blood a haemolysis appears and therefore distorted potassium concentrations are measured.

In the study K@Home_1 it is a matter of evaluating, how high the degree of the haemolysis in capillary blood is, and in this fact to what extent leads to wrong potassium values. The results from this study will be a basic component for the sensor development.

After clarification the approval the Informed Consent is signed and the inclusion as well as exclusion criteria (incl. demography, concomitant medication and medical history) or vital parameters (blood pressure, pulse, size, weight), are raised. An urine-pregnancy test is also carried out for the exclusion of a pregnancy in women capable of bearing children. It is not necessary that the subjects seem sober on the study day.

With 22 healthy subjects capillary and venous blood is taken within the scope of one single study round. Blood is taken from the test persons by trained specialist staff of two fingertips of each hand (a total of four fingertips). The capillary blood sampling occurs in 200 µ l Lithium-Heparin Sarsted Microvettes and in each case the first drop of blood is rejected. To guarantee a light blood decrease without strong mechanical pressure, the hands are warmed up before the capillary sampling required with the help of an electric blanket or by warm water roughly on room temperature.

研究设计

研究类型
Observational
观察模型
Case Only

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Male or female
  • Signed informed consent before any trial-related activities

排除标准

  • Severe acute and/or chronic diseases
  • Mental incapacity, unwillingness of language barriers precluding adequate understanding or cooperation
  • Pregnancy or breastfeeding
  • Any disease or condition which the investigator or treating physician feels would interfere with the trial or the safety of the subject

结局指标

主要结局

Measured potassium concentration in capillary blood tests compared to venous blood tests.

时间窗: 1 hour

次要结局

  • Correlation from fHb and potassium(1 hour)
  • Degree of haemolysis in capillary blood tests compared to venous blood tests.(1 hour)

研究者

发起方
Medical University of Graz
申办方类型
Other
责任方
Sponsor

相似试验