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临床试验/NCT06438458
NCT06438458尚未招募不适用

Effect of Postural Change on Hemoglobin Level in Patients on the Intensive Care Unit

Deventer Ziekenhuis2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2024年6月17日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
24
试验地点
2
主要终点
Hemoglobin

研究概览

简要总结

Monitoring hemoglobin levels (Hb) is important to identify anemia in hospitalized patients. Changes in posture and mobilization efforts, as demonstrated by previous research, can lead to significant shifts in Hb concentrations. This phenomenon has not been studied in ICU patients.

This study aims to investigate whether postural changes and mobilisation affect Hb in ICU patients. We hypothesize that significant Hb shifts may occur, potentially leading to misinterpretations of anemia and unnecessary diagnostic and therapeutic workup. Understanding this impact can guide clinical practice and prevent unwarranted interventions.

详细描述

Rationale:

Monitoring hemoglobin levels (Hb) is important to identify anemia in hospitalized patients. Changes in posture and mobilization efforts, as demonstrated by previous research, can lead to significant shifts in Hb concentrations. Low Hb levels due to these shifts are termed 'postural pseudoanemia'.

This phenomenon has not been studied in ICU patients. Many factors may affect Hb concentrations in ICU patients, including plasma volume shifts, bleeding, repeated phlebotomies, hemolysis, bone marrow suppression and functional iron deficiency. When this leads to significant anemia, patients may be treated with red blood cell transfusions. However, blood transfusions have been associated with adverse reactions and should only be performed for appropriate indications. If postural pseudoanemia occurs in ICU patients this could lead to patient harm through inadvertent investigations and red blood cell transfusions. The occurrence of postural pseudoanemia in ICU patients may differ from previous studies because ICU patients are more frequently immobilized for more prolonged periods.

This study aims to investigate whether postural changes affect Hb in ICU patients. We hypothesize that significant Hb shifts may occur, potentially leading to misinterpretations of anemia and unnecessary diagnostic and therapeutic workup. Understanding this impact can guide clinical practice and prevent unwarranted interventions.

Objective:

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Sequential
主要目的
Diagnostic
盲法
None

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

  • Age over 18 years, of any gender and ethnic background
  • Admitted to the intensive care unit
  • Able to give informed consent
  • Patients with an arterial line as part of their treatment plan.
  • Patients able to remain seated in chair for at least 30 minutes
  • Patients able to remain supine overnight for at least 6 hours

排除标准

  • Delirium or inability to give informed consent
  • Inability to understand written information in Dutch
  • Patients on artificial ventilation
  • Orotracheally intubated patients (spontaneous breathing through a tracheostomy cannula is allowed)
  • Patients treated with noradrenaline > 0.05 ug/kg/min
  • Patients treated with argipressin
  • Patients who received a blood transfusion within 24 hours before measurements
  • Patients who received > 3 L of fluids within 24 hours before measurements
  • Patients who received > 500 ml of iv fluids within 4 hours of measurements
  • Severe restlessness or inability to remain supine for 6 hours before initial blood sampling
  • Patients being treated with diuretics
  • Patients admitted with:
  • Decompensated right heart failure
  • Pulmonary hypertension
  • Pulmonary embolism
  • Active bleeding or risk of >100 ml blood loss
  • Hematological disorder/malignancy

结局指标

主要结局

Hemoglobin

时间窗: 3 hours

Hemoglobin concentration

次要结局

  • Albumin(3 hours)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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