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临床试验/NCT07467889
NCT07467889已完成不适用

The Carnitine Dichotomy in CRRT: Dialytic Depletion of Short-Chain Fractions Versus Retention of Long-Chain Mitochondrial Biomarkers.

Gulhane Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2023年1月1日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
43
试验地点
1
主要终点
Extracorporeal Clearance of Micronutrients and Carnitine

研究概览

简要总结

This study aims to investigate the changes in blood levels of micronutrients and carnitine in critically ill patients with Acute Kidney Injury (AKI) who are undergoing Continuous Renal Replacement Therapy (CRRT). While CRRT is a life-saving intervention for managing metabolic disturbances and fluid overload in patients with Stage 2-3 AKI, it may also lead to the inadvertent removal of essential micronutrients (vitamins, trace elements, and amino acids) through the extracorporeal circuit.

The research will prospectively compare 100 adult patients across two groups: those receiving CRRT and those managed without CRRT. Researchers will analyze blood samples and effluent fluid to determine the clearance rates and total losses of various substances, including carnitine, selenium, zinc, and various amino acids. By comparing levels at the first hour and 24th hour of intensive care admission, the study seeks to determine if CRRT significantly contributes to micronutrient deficiencies in this vulnerable population.

详细描述

Background and Rationale:

Acute Kidney Injury (AKI) is characterized by a sudden loss of glomerular filtration rate and is a major factor increasing mortality and morbidity in hospitalized patients. In critically ill patients, Continuous Renal Replacement Therapy (CRRT) is frequently used to manage metabolic disturbances and fluid overload due to its advantages in hemodynamic stability. However, exposure to the extracorporeal circuit may lead to significant losses of micronutrients, including trace elements (e.g., selenium, zinc, copper) and water-soluble vitamins, which play crucial roles in cellular function and metabolism.

Study Objective:

The primary objective of this prospective study is to investigate the changes in serum and effluent (waste fluid) micronutrient levels in patients undergoing CRRT and to compare these levels with patients who have Stage 2-3 AKI but do not require CRRT.

Methodology and Procedures:

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged 18-90 years
  • Diagnosis of AKI Stage 2 or 3 according to KDIGO
  • Evaluation for CRRT requirement within the first hour of ICU admission.

排除标准

  • End-stage renal disease or history of chronic RRT
  • AKI due to dialyzable toxins,Child-Pugh C liver cirrhosis
  • Terminal malignancy,AKI secondary to cardiac arrest
  • High risk of mortality within the first 24 hours
  • Prior RRT for the current AKI episode,History of kidney transplantation
  • Prior inclusion in this study
  • Pregnancy or breastfeeding
  • Lack of informed consent from the patient or legal representative.

结局指标

主要结局

Extracorporeal Clearance of Micronutrients and Carnitine

时间窗: At the 24th hour of Continuous Renal Replacement Therapy (CRRT)

Calculation of the clearance rates for trace elements (selenium, zinc, copper, iron), carnitine subforms, and 22 different amino acids by analyzing their concentrations in the blood and effluent (waste fluid) during the 24-hour Continuous Renal Replacement Therapy (CRRT) period.

次要结局

  • Changes in Serum Carnitine Concentrations(Baseline (1st hour of admission) and 24 hours)
  • comparison of serum amino acid concentration(first hour of intensive care unite admission and the 24th hour)
  • comparison of serum vitamins(B12,folat) concentrations(first hour of intensive care admission and the 24 th hour)
  • The difference in micronutrient status between patients receiving and not receiving CRRT.(24 hours after hospital admission/start of treatment.)
  • Clinical Correlation(Through study completion (up to 24 hours))

研究者

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

Mete Erdemir

Intensivist, Intensive Care Unit

Gulhane Training and Research Hospital

研究点 (1)

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