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临床试验/NCT05582824
NCT05582824招募中不适用

Lactate Metabolism in Patientens With Hyperlactatemia-associated Metabolic Acidosis

University of Copenhagen1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2022年9月15日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
20
试验地点
1
主要终点
Laktate levels in blood

研究概览

简要总结

Investigating lactate metabolism in critically ill patients whom are hypoperfused by preforming metabolomics via liquid chromatography-mass spectrometry.

详细描述

Lactate concentration is well known to be directly correlated with risk of death during admission to intensive care. However, lactate by itself is not considered toxic. The study is observational. The breakdown of lactate is being investigated by collecting blood- and urinsamples from patients with hyperlactatemia as a result of hypoperfusion. Levels of lactate, and known as well as unknown metabolites will be identified and quantified by metabolomics. Metabolomics is performed using a combination of liquid chromatography and mass spectrometry. Data will be analysed via statistical analysis to investigate corelations between lactate, a given metabolite and hard outcome such as mortality. And thereby lay the groundwork for potential further research regarding specific lactate-metabolites.

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

  • Diagnosed with sepsis/septic shock or severe heart failure.
  • Clinical and paraclinical signs of hypoperfusion in relation to abovementioned diagnosis.
  • Metabolic acidosis with s-lactate equal-to-or-above 4 mmol/l.
  • Incapacitated

排除标准

  • Only regional hypoperfusion such as a leg.
  • Receiving intravenous lactate as part of treatment.
  • Going in to dialysis. The exclusion is only during dialysis treatment.

结局指标

主要结局

Laktate levels in blood

时间窗: Daily testing. Average time frame for the paticipants are 3 days (ranging from 1-10 days).

Levels of lactate in the blood in relation to the key metabolites (secondary outcomes). Patients included will be testet daily during admission to intensive care whilst lactate is above 2 mmol/l and one more day while laktat is below.

次要结局

  • Metabolomics using High Pressure Liquid Cromotografy (HPLC) and Mass Spectrometry (MS)(Two seperate days. One in december 2022 and one in approximately february 2023 (when all patientens are included and all samples are collected).)
  • Pyruvate and hydroxybuterate concentration in blood and urine(Two seperate days. One in december 2022 and one in approximately february 2023 (when all patientens are included and all samples are collected).)
  • Near-infrared spectroscopy (NIRS)(Daily testing. Average time frame for the paticipants are 3 days (ranging from 1-10 days).)
  • Mortality(Admission time ranges up to 6 months.)
  • Peripheral perfusion index (PPI)(Daily testing. Average time frame for the paticipants are 3 days (ranging from 1-10 days).)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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