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

March 17, 2025 updated by: Puk Kristiansen, Copenhagen University Hospital, Hvidovre

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

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

25

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2960
        • Recruiting
        • Hvidovre University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in total blood volume (TBV)
Time Frame: Preoperatively and 6 hours postoperatively
Measured in milliliter (mL)
Preoperatively and 6 hours postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in total blood volume (TBV)
Time Frame: Preoperatively and 24 hours postoperatively
measured in mL
Preoperatively and 24 hours postoperatively
Changes in total hemoglobin mass (tHgb)
Time Frame: Preoperatively, 6 hours postoperatively and 24 hours postoperatively
Measured in gram (g)
Preoperatively, 6 hours postoperatively and 24 hours postoperatively
Changes in erythrocyte volume (EBV)
Time Frame: Preoperatively, 6 hours postoperatively and 24 hours postoperatively
Measured in mL
Preoperatively, 6 hours postoperatively and 24 hours postoperatively
Changes in plasma volume (PV)
Time Frame: Preoperatively, 6 hours postoperatively and 24 hours postoperatively
Measured in mL
Preoperatively, 6 hours postoperatively and 24 hours postoperatively
Changes in hematokrit (Ht)
Time Frame: Preoperatively, 6 hours postoperatively and 24 hours postoperatively
Reported as percentage(%)
Preoperatively, 6 hours postoperatively and 24 hours postoperatively
Changes in hemoglobin (Hg) concentration
Time Frame: Preoperatively, 6 hours postoperatively and 24 hours postoperatively
Measured in millimoles/liter(mmol/L)
Preoperatively, 6 hours postoperatively and 24 hours postoperatively
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.
Preoperatively, 6 hours postoperatively and 24 hours postoperatively
Changes in C-Reactive Protein (CRP)
Time Frame: Preoperatively, 6 hours postoperatively and 24 hours postoperatively
Measured in milligram/liter (mg/L)
Preoperatively, 6 hours postoperatively and 24 hours postoperatively
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
Preoperatively, 6 hours postoperatively and 24 hours postoperatively
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
Preoperatively, 6 hours postoperatively and 24 hours postoperatively
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
Preoperatively, 6 hours postoperatively and 24 hours postoperatively
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
Preoperatively, 6 hours postoperatively and 24 hours postoperatively
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
Preoperatively, 6 hours postoperatively and 24 hours postoperatively

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraoperativ estimation of bleeding
Time Frame: Intraoperative at end of the surgical procedure
Measured by weighting gauze (gram)
Intraoperative at end of the surgical procedure
Intraoperative bleeding
Time Frame: Intraoperative at end of the surgical procedure
Measured by visual estimation in surgical drains (mL)
Intraoperative at end of the surgical procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Copenhagen University Hospital, Hvidovre

Investigators

  • Study Director: Nicolai Foss, Professor, Dr. Med., Department of Anesthesiology and Intensive Care Medicine, Copenhagen University Hospital, Hvidovre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2025

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

March 8, 2025

First Submitted That Met QC Criteria

March 17, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 17, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • H-24062107

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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