Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 12:06 AM
Ignite Modification Date:
2025-12-25 @ 12:06 AM
NCT ID:
NCT06438458
Brief Summary:
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.
Detailed Description:
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:
Main objective: To assess Hb levels in ICU patients upon a change in posture from supine to upright and following mobilization to a chair.
Secondary objectives:
To seek correlations between hemoglobin shifts and changes in serum albumin concentrations upon a change in posture from supine to sitting and following mobilization to a chair.
To seek correlations between hemoglobin shifts and changes in serum uric acid concentrations upon a change in posture from supine to sitting and following mobilization to a chair.
To seek correlations between hemoglobin shifts and levels of CRP and ESR upon a change in posture from supine to sitting and following mobilization to a chair.
To compare hemoglobin concentrations following \> 6 hours in supine position at 24 hours with pre-intervention levels for patients remaining in the ICU.
Any other changes seen in the lab measurements or vital parameters upon a change in posture?
Study design:
Prospective uncontrolled interventional study.
Study population:
Patients \> 18 years old, admitted to the intensive care unit.
Intervention:
All patients will undergo a change in posture from supine to upright, followed by mobilization to a chair.
Main study parameters/endpoints:
Relative percentage change in Hb.
Study:
NCT06438458
Study Brief:
Protocol Section:
NCT06438458