Onderzoek Naar Intracutane Natriumopslag Bij Intensive Care patiënten (InCa-studie)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Difference in sodium concentration in skin biopsy between groups
研究概览
简要总结
This study investigates the differens in sodium storage in skin between normal subjects, patients after cardiac surgery and septic patients.
详细描述
According to the current paradigm ICU-acquired hypernatremia is mainly an iatrogenic problem, caused by sodium overload or water deficit. In spite of several interventions to reduce sodium intake and optimize fluid balance, critically ill patients still develop hypernatremia. These patients also seem to have an inability to excrete sodium, hence develop a positive sodium balance. In animals sodium storage in the third compartment was found. Our hypothesis is that sodium storage in the third compartment is different in critically ill patients and this difference could play a role in the development of ICU-acquired hypernatremia.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 45 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •50-80 years (septic patients), 45-85 years (CABG and hip replacement-patients)
- •Patients undergoing hip replacement: no relevant medical history (i.e. chronic and/or systemic diseases with a suspected influence on sodium / sodium handling)
- •Septic patients: fulfilling the criteria for the systemic inflammatory response syndrome in the presence of a(n expected) new infection
排除标准
- •Absence of both upper legs
- •Skin disease that makes skin biopsies in healthy skin impossible
- •Subjects with in their history formation of exaggerated scar tissue
- •Subjects suffering from psoriasis or lichen ruber
- •Use of skin corticosteroids on all skin of both upper legs < 2 weeks before inclusion
- •Tattoos covering the whole surface of both upper legs
- •Use of diuretics in the past month
- •Current renal replacement therapy
- •Septic patients: not being sedated
- •Patients undergoing hip replacement: hip replacement because of an inflammatory disease
结局指标
主要结局
Difference in sodium concentration in skin biopsy between groups
时间窗: Different for the separate groups: before hip replacement, within 2 hours after CABG and within 12 hours after admission for septic patients
Skin biopsies will be taken within the described time frame, analysis will take place after all biopsies of all subjects are included
次要结局
- Immunohistochemistry: binding capacity of proteoglycans(Different for the separate groups: before hip replacement, within 2 hours after CABG and within 12 hours after admission for septic patients)
- Immunohistochemistry: presence of macrophage influx(Different for the separate groups: before hip replacement, within 2 hours after CABG and within 12 hours after admission for septic patients)
- Quantification of different matrix components / proteoglycans: versican (if enough tissue is available)(Different for the separate groups: before hip replacement, within 2 hours after CABG and within 12 hours after admission for septic patients)
- Immunohistochemistry: outcomes of proteoglycans(Different for the separate groups: before hip replacement, within 2 hours after CABG and within 12 hours after admission for septic patients)
- mRNA profiling of proteoglycans and synthesizing enzymes by way of RNA-isolation - if enough tissue is available(Different for the separate groups: before hip replacement, within 2 hours after CABG and within 12 hours after admission for septic patients)
- Immunohistochemistry: density of lymph capillaries(Different for the separate groups: before hip replacement, within 2 hours after CABG and within 12 hours after admission for septic patients)
- Quantification of different matrix components / proteoglycans: decorine - if enough tissue is available(Different for the separate groups: before hip replacement, within 2 hours after CABG and within 12 hours after admission for septic patients)
- Quantification of different matrix components / proteoglycans: biglycan- if enough tissue is available(Different for the separate groups: before hip replacement, within 2 hours after CABG and within 12 hours after admission for septic patients)