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RecruitingNCT06888908Updated Mar 21, 2025

Changes in Perioperative Blood Volume and Fluid Distribution in Patients Undergoing Primary Total Hip Replacement.

An observational study in Hip Arthroplasty Replacement, sponsored by Copenhagen University Hospital, Hvidovre. Recruiting at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-21.

Sponsored by Copenhagen University Hospital, Hvidovre · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
25
Ages
18 Years and older
Sex
All
01

Study summary

Clinical assessment of bleeding and calculation of perioperative blood loss do not provide an accurate estimate of blood volume. This makes rational fluid management difficult, which is of high importance for patient-related outcomes. The availability of carbon monoxide(CO)-rebreathing allows for simple, non-invasive and precise measurement of changes in blood volume.

The purpose of the study is to investigate and describe changes in blood volume and fluid distribution perioperative in patients undergoing total hip arthroplasty. Furthermore, to investigate the association between changes in blood volume and incidence of orthostatic insufficiency.

02

Conditions studied

  • Hip Arthroplasty Replacement

Keywords

  • Blood loss
  • Blood volume
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients scheduled for an elective total hip arthoplasty (THA) at Hvidovre University Hospital and undergo the proceduce under spinal anesthesia with propofol sedation.

Inclusion criteria

  • Patients scheduled for an elective total hip arthoplasty (THA) in a standardized fast track setting.
  • Capable of participating in CO-rebreathing measurement
  • Age ≥ 18 years
  • Able to speak and understand Danish
  • Has provided written informed consent.

Exclusion criteria

Exclusion Criteria:

  • Intraoperative blood loss exceeding 750 mL.
  • Perioperative need for a blood transfusion.
  • Confirmed or suspected coagulopathies.
  • Factors that make CO-rebreathing measurement impossible.
  • Known orthostatic intolerance.
  • American Society of Anesthesiologists physical status (ASA) classification ≥ 4.
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
25 participants (estimated)
Patient registry
No
05

What researchers measure

Primary outcomes

  1. Change in total blood volume (TBV)

    Measured in milliliter (mL)

    Time frame: Preoperatively and 6 hours postoperatively

Secondary outcomes

  1. Change in total blood volume (TBV)

    measured in mL

    Time frame: Preoperatively and 24 hours postoperatively

  2. Changes in total hemoglobin mass (tHgb)

    Measured in gram (g)

    Time frame: Preoperatively, 6 hours postoperatively and 24 hours postoperatively

  3. Changes in erythrocyte volume (EBV)

    Measured in mL

    Time frame: Preoperatively, 6 hours postoperatively and 24 hours postoperatively

  4. Changes in plasma volume (PV)

    Measured in mL

    Time frame: Preoperatively, 6 hours postoperatively and 24 hours postoperatively

  5. Changes in hematokrit (Ht)

    Reported as percentage(%)

    Time frame: Preoperatively, 6 hours postoperatively and 24 hours postoperatively

  6. Changes in hemoglobin (Hg) concentration

    Measured in millimoles/liter(mmol/L)

    Time frame: Preoperatively, 6 hours postoperatively and 24 hours postoperatively

  7. Changes in Total body water(TBW), intra-(ICF) and extracellular(ECF) fluid distribution

    Full body water via bioelectrical impedance analysis. The individual components are reported in L and percent.

    Time frame: Preoperatively, 6 hours postoperatively and 24 hours postoperatively

  8. Changes in C-Reactive Protein (CRP)

    Measured in milligram/liter (mg/L)

    Time frame: Preoperatively, 6 hours postoperatively and 24 hours postoperatively

  9. Incidence of orthostatic intolerance during mobilization

    Symptoms of orthostatic intolerance: dizziness, nausea, vomiting, blurry vision or syncope during mobilization

    Time frame: Preoperatively, 6 hours postoperatively and 24 hours postoperatively

  10. Association between total blood loss and incidence of orthostatic intolerance

    Blood loss measured in mL. Symptoms of orthostatic intolerance: dizziness, nausea, vomiting, blurry vision or syncope during mobilization

    Time frame: Preoperatively, 6 hours postoperatively and 24 hours postoperatively

  11. Association between changes in C-Reactive Protein and total blood loss

    C-Reactive Protein measured in mg/L and total blood loss measured in mL

    Time frame: Preoperatively, 6 hours postoperatively and 24 hours postoperatively

  12. Association between peripheral perfusion index and total blood loss

    Peripheral perfusion index measured in percent and total blood loss in mL

    Time frame: Preoperatively, 6 hours postoperatively and 24 hours postoperatively

  13. Association between total hemoglobin (SpHb) and total blood loss

    SpHb measured as gram/deciliter and total blood loss measured in mL

    Time frame: Preoperatively, 6 hours postoperatively and 24 hours postoperatively

Other outcomes

  1. Intraoperativ estimation of bleeding

    Measured by weighting gauze (gram)

    Time frame: Intraoperative at end of the surgical procedure

  2. Intraoperative bleeding

    Measured by visual estimation in surgical drains (mL)

    Time frame: Intraoperative at end of the surgical procedure

06

Study locations

1 of 1 sites recruiting
  • Hvidovre University Hospital
    Copenhagen, 2960, Denmark
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06888908
Lead sponsor
Copenhagen University Hospital, Hvidovre
Responsible party
Puk Kristiansen (MD, Ph.d.-student, Copenhagen University Hospital, Hvidovre) — Principal investigator
First posted
Mar 21, 2025
Start date
Mar 2025 (estimated)
Primary completion
Sep 2026 (estimated)
Completion
Sep 2026 (estimated)
Last update
Mar 21, 2025

Study contacts

Puk Kristiansen, MD
Contact
puk.kristiansen@regionh.dk
+4530291189
Ana-Marija Hristovska, Senior registrar, Ph.D.
Contact
ana-marija.hristovska.02@regionh.dk
Nicolai Foss, Professor, Dr. Med.
study director · Department of Anesthesiology and Intensive Care Medicine, Copenhagen University Hospital, Hvidovre

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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