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Clinical Trials/NCT06438458
NCT06438458Not yet recruitingNot Applicable

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

Deventer Ziekenhuis1 site in 1 country24 target enrollmentStarted: June 17, 2024Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
24
Locations
1
Primary Endpoint
Hemoglobin

Study Overview

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:

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Sequential
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •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

Exclusion Criteria

  • •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

Arms & Interventions

Hb in different positions

Experimental

Hemoglobin concentration after sitting in bed (passively) for >30 min, and after mobilization to a chair for >30 min

Intervention: Postural change from supine to sitting (Procedure)

Hb in different positions

Experimental

Hemoglobin concentration after sitting in bed (passively) for >30 min, and after mobilization to a chair for >30 min

Intervention: Mobilization to a chair (Procedure)

Outcomes

Primary Outcomes

Hemoglobin

Time Frame: 3 hours

Hemoglobin concentration

Secondary Outcomes

  • Albumin(3 hours)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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