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临床试验/NCT02914782
NCT02914782已完成不适用

An Open Monocentric Observational Study to Investigate Fluid- and Electrolyte Balance in Post Cardiac-surgery Patients in the ICU

Medical University of Graz1 个研究点 分布在 1 个国家目标入组 176 人开始时间: 2016年9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
176
试验地点
1
主要终点
Routine laboratory measurements and ELISA to define urinary and serum biomarkers for the early diagnosis of acute kidney injury.

研究概览

简要总结

Critically ill patients need intravenous fluid therapy in order to correct or prevent problems with their fluid and/or electrolyte status and for renal protection. The decision for the optimal composition and amount of IV-fluids can be difficult and complex. It is well known that errors in fluid- and electrolyte management contribute to overall morbidity and mortality. For decades, urinary sodium was used to diagnose renal disease. Nevertheless, renal excretion of sodium is largely impaired in critically ill patients, particularly in patients with acute kidney injury. Due to the high frequent measurement of renal output, it would be possible to measure the urinary electrolytes and its relative changes. Urinary electrolyte measurement may alert for the presence of the development of an akute kidney injury before occurring increases in creatinine or oliguria. The rationale of this investigation is therefore to collect data related to fluid- and electrolyte management from critically ill patients in order to find patterns of fluid- and electrolyte imbalances which may lead to disturbances and further, may allow an early detection of acute kidney injury.

详细描述

Critically ill patients need intravenous fluid therapy in order to correct or prevent problems with their fluid and/or electrolyte status and for renal protection. The decision for the optimal composition and amount of IV-fluids can be difficult and complex. It is well known that errors in fluid- and electrolyte management contribute to overall morbidity and mortality.

Due to the administration of large volumes of normal saline and/or a decreased urinary output of sodium or chloride iatrogen electrolyte disorders, such as hyperchloremic acidosis or dysnatremia are common abnormalities in the clinical practice. The common fact that normal saline has non-physiological levels of chloride and sodium, intensifies this problem with high volume administration. (Burdett et al. 2003; Adrogué & Madias 1997).

Hypernatremia is an independent risk factor for mortality in critically ill patients and increases the length of ICU stay (Lindner et al. 2010; Stieglmair et al. 2013) Hypernatremia is associated with impaired renal fluid regulation, as well as a lack of thirst mechanisms. In the ICU this fact requires exact measurement of all fluid- and electrolyte intake and (non-)renal losses. (Lindner et al. 2009). Therefore, in critical care settings measuring fluid balance (the difference between infusion input and renal / non-renal losses) is daily routine. The renal output is measured frequently by the nursing staff. An automated acquisition of the urinary output combined with the data of the infusion site would reduce the workload of the staff and would allow visualization of the fluid status.

Furthermore, beyond volume, the concentration and composition of the fluid is an important parameter. The comparison of urinary electrolytes with the electrolyte input from infusions allows an early detection of electrolyte disorders (Besen et al. 2015). Sodium and chloride are the main ions of solutions infused into critically ill patients. The excessive infusion of fluids lead to sodium and chloride overloads and is associated with higher mortality (Noritomi et al. 2009). For decades, urinary sodium was used to diagnose renal disease. Nevertheless, renal excretion of sodium is largely impaired in critically ill patients, particularly in patients with acute kidney injury. Due to the high frequent measurement of renal output, it would be possible also to measure the urinary electrolytes and its relative changes which are likely to be more relevant than the absolute electrolyte concentrations. Urinary electrolyte measurement may alert for the presence of AKI development before occurring increases in creatinine or oliguria (Maciel 2013; Maciel et al. 2015; Molitoris 2013).

The rationale of this investigation is therefore to collect data related to fluid- and electrolyte management from critically ill patients in order to find patterns of fluid- and electrolyte imbalances which may lead to disturbances and further, may allow an early detection of acute kidney injury (AKI).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • i. 8 years or older ii. Expected length of stay at the ICU > 48 hours iii. eGFR (CKD-EPI) > 45 ml/min iv. ACR < 300 mg/g creatinine v. signed informed consent prior to cardiac surgery

排除标准

  • i. renal insufficiency (eGFR-CKD-EPI < 45 ml/min), dialysis ii. severe infection (fever > 38 °C, CRP > 50 ml/l) iii. increased risk for perioperative multi-organ failure due to co-morbidities such as cardiogenic decompensation pre-surgery, low cardiac output, incipient cardiogenic shock and sepsis iv. Karnofsky Index < 40 v. hearing impairment vi. physical and mental illnesses vii. missing signed informed consent

结局指标

主要结局

Routine laboratory measurements and ELISA to define urinary and serum biomarkers for the early diagnosis of acute kidney injury.

时间窗: 1 year

Serum and urine will be collected multiple times daily and analyzed for Na, K, Osmolality, Cl and oxygen concentration. Serum and urine ELISA assays will be carried out to detect changes in concentration of KIM-1, NGAL, Cystatin-C and E-Selectin.

次要结局

  • Measurement of fluid input and output (ml) to define trends in electrolyte and fluid balance using electronic data from ICU(1 year)

研究者

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

研究点 (1)

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