Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06438458
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-03
First Post:
2024-05-21
Brief Title:
Effect of Postural Change on Hemoglobin Level in Patients on the Intensive Care Unit
Sponsor:
Deventer Ziekenhuis
Organization:
Deventer Ziekenhuis
Study Overview
Official Title:
Effect of Postural Change on Hemoglobin Level in Patients on the Intensive Care Unit
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 parametersendpoints
Relative percentage change in Hb
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 parametersendpoints
Relative percentage change in Hb
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None