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NCT Number: NCT06888908

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

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.

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Key information

Conditions

Hip Arthroplasty Replacement Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hvidovre University Hospital

Copenhagen, 2960, Denmark

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

Primary outcomes

  1. Change in total blood volume (TBV)

    Time frame: Preoperatively and 6 hours postoperatively

    Measured in milliliter (mL)

Secondary outcomes

  1. Change in total blood volume (TBV)

    Time frame: Preoperatively and 24 hours postoperatively

    measured in mL

  2. Changes in total hemoglobin mass (tHgb)

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

    Measured in gram (g)

  3. Changes in erythrocyte volume (EBV)

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

    Measured in mL

  4. Changes in plasma volume (PV)

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

    Measured in mL

  5. Changes in hematokrit (Ht)

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

    Reported as percentage(%)

  6. Changes in hemoglobin (Hg) concentration

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

    Measured in millimoles/liter(mmol/L)

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

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

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

  8. Changes in C-Reactive Protein (CRP)

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

    Measured in milligram/liter (mg/L)

  9. Incidence of orthostatic intolerance during mobilization

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

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

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

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

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

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

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

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

  12. Association between peripheral perfusion index and total blood loss

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

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

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

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

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

Other outcomes

  1. Intraoperativ estimation of bleeding

    Time frame: Intraoperative at end of the surgical procedure

    Measured by weighting gauze (gram)

  2. Intraoperative bleeding

    Time frame: Intraoperative at end of the surgical procedure

    Measured by visual estimation in surgical drains (mL)

Study contacts

Contact information is provided by the study sponsor or research team.

Ana-Marija Hristovska, Senior registrar, Ph.D.

CONTACT

[email protected]

Puk Kristiansen, MD

CONTACT

[email protected]

+4530291189

Sponsors and collaborators

Lead sponsor

Copenhagen University Hospital, Hvidovre

Other

Registry information

Official study title

Perioperative Change in Blood Volume and Fluid Distribution in Total Hip Arthroplasty

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 21, 2025
Registry last updated
Mar 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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