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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 21, 2024

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 3, 2024

Completed
14 days until next milestone

Study Start

First participant enrolled

June 17, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2024

Completed
Last Updated

June 3, 2024

Status Verified

May 1, 2024

Enrollment Period

5 months

First QC Date

May 21, 2024

Last Update Submit

May 30, 2024

Conditions

Anemia

Keywords

Blood compositionCirculatory physiology

Outcome Measures

Primary Outcomes (1)

  • Hemoglobin

    Hemoglobin concentration

    3 hours

Secondary Outcomes (1)

  • Albumin

    3 hours

Other Outcomes (1)

  • Uric acid

    3 hours

Study Arms (1)

Hb in different positions

EXPERIMENTAL

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

Procedure: Postural change from supine to sittingProcedure: Mobilization to a chair

Interventions

Postural change from supine to sittingPROCEDURE

Patients go from supine to sitting position in bed (passive)

Hb in different positions
Mobilization to a chairPROCEDURE

Patients go from the bed to sitting in a chair (active)

Hb in different positions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Deventer Hospital

Deventer, 7416SE, Netherlands

Location

MeSH Terms

Conditions

Anemia

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Alfred L van Steveninck, M.D., Ph.D.

    Deventer Ziekenhuis

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alfred L van Steveninck, M.D., Ph.D.

CONTACT

+31570535346f.steveninckvan@dz.nl

Huub LA van den Oever, M.D.

CONTACT

+31570535346h.vandenoever@dz.nl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SEQUENTIAL
Model Details: Blood samples are taken before and after the interventions
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 21, 2024

First Posted

June 3, 2024

Study Start

June 17, 2024

Primary Completion

October 30, 2024

Study Completion

October 30, 2024

Last Updated

June 3, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will share

Data can be obtained from the principal investigator upon request.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
After preparation of the manuscript.
Access Criteria
A written request must be sent to the principal investigator.

Locations

NL(1)