AnemiaNCT06438458
Effect of Postural Change on Hemoglobin Level in Patients on the Intensive Care Unit
A study testing Postural change from supine to sitting and Mobilization to a chair in people with Anemia, run by Deventer Ziekenhuis at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anemia
- What is being tested?
- Postural change from supine to sitting and Mobilization to a chair
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteNetherlands
- Study dates
- 17 Jun 2024to 30 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Deventer Hospital
Deventer, 7416SE
Alfred L van Steveninck, M.D., Ph.D., +31570535346, f.steveninckvan@dz.nl
Huub LA van den Oever, M.D., +31570535346, h.vandenoever@dz.nl
About this study
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.
Read the 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.
- Conditions
- Anemia
- Being tested
- Postural change from supine to sitting, Mobilization to a chair
- Keywords
- Blood composition, Circulatory physiology
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Postural change from supine to sittingProcedure or surgery
Patients go from supine to sitting position in bed (passive)
Mobilization to a chairProcedure or surgery
Patients go from the bed to sitting in a chair (active)
| Study group | Role | What they receive |
|---|---|---|
| Hb in different positions | Experimental | Hemoglobin concentration after sitting in bed (passively) for >30 min, and after mobilization to a chair for >30 min Receives: Procedure: Postural change from supine to sitting; Procedure: Mobilization to a chair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin
Hemoglobin concentration
Measured: 3 hours
Secondary outcomes (1)
Albumin
Albumin concentration
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2024
- Study start17 Jun 2024 (estimated)
- Primary completion30 Oct 2024 (estimated)
- Study completion30 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- Blood samples are taken before and after the interventions
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Deventer Ziekenhuis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alfred L van Steveninck, M.D., Ph.D., Principal investigator, Deventer Ziekenhuis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06438458
- Sponsor's protocol ID
- NL86966
- Status last verified
- May 2024
- First submitted
- 21 May 2024
- Last updated
- 3 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data can be obtained from the principal investigator upon request.
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Postural Change on Hemoglobin Level in Patients on the Intensive Care Unit
- ClinicalTrials.gov ID
- NCT06438458
- Acronym / sponsor ID
- NL86966
- Conditions
- Anemia
- Keywords
- Blood composition, Circulatory physiology
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Deventer ZiekenhuisUniversity, hospital or other
- Study start
- 17 Jun 2024 (estimated)
- Primary completion
- 30 Oct 2024 (estimated)
- Study completion
- 30 Oct 2024 (estimated)
- First posted
- 3 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Blood samples are taken before and after the interventions
| Arm | Type | Receives |
|---|---|---|
| Hb in different positions | Experimental | Procedure: Postural change from supine to sitting, Procedure: Mobilization to a chairHemoglobin concentration after sitting in bed (passively) for >30 min, and after mobilization to a chair for >30 min |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Postural change from supine to sittingPatients go from supine to sitting position in bed (passive) | Procedure or surgery | Hb in different positions |
| Mobilization to a chairPatients go from the bed to sitting in a chair (active) | Procedure or surgery | Hb in different positions |
Primary outcome
Hemoglobin
Time frame: 3 hours
Hemoglobin concentration
1 secondary outcome
Albumin
Time frame: 3 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2024.
- Individual participant dataSharing planned: Yes. Data can be obtained from the principal investigator upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alfred L van Steveninck, M.D., Ph.D. principal investigator
Deventer Ziekenhuis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Postural change from supine to sitting and Mobilization to a chair in people with Anemia, run by Deventer Ziekenhuis at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alfred L van Steveninck, M.D., Ph.D. (+31570535346, f.steveninckvan@dz.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemoglobin (time frame: 3 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2024.