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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06888908
Enrollment
25
Registered
2025-03-21
Start date
2025-03-31
Completion date
2026-09-30
Last updated
2025-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hip Arthroplasty Replacement

Keywords

Blood loss, Blood volume

Brief 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.

Interventions

None listed

Sponsors

Copenhagen University Hospital, Hvidovre
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in total blood volume (TBV)Preoperatively and 6 hours postoperativelyMeasured in milliliter (mL)

Secondary

MeasureTime frameDescription
Change in total blood volume (TBV)Preoperatively and 24 hours postoperativelymeasured in mL
Changes in total hemoglobin mass (tHgb)Preoperatively, 6 hours postoperatively and 24 hours postoperativelyMeasured in gram (g)
Changes in erythrocyte volume (EBV)Preoperatively, 6 hours postoperatively and 24 hours postoperativelyMeasured in mL
Changes in plasma volume (PV)Preoperatively, 6 hours postoperatively and 24 hours postoperativelyMeasured in mL
Changes in hematokrit (Ht)Preoperatively, 6 hours postoperatively and 24 hours postoperativelyReported as percentage(%)
Changes in hemoglobin (Hg) concentrationPreoperatively, 6 hours postoperatively and 24 hours postoperativelyMeasured in millimoles/liter(mmol/L)
Changes in Total body water(TBW), intra-(ICF) and extracellular(ECF) fluid distributionPreoperatively, 6 hours postoperatively and 24 hours postoperativelyFull body water via bioelectrical impedance analysis. The individual components are reported in L and percent.
Association between peripheral perfusion index and total blood lossPreoperatively, 6 hours postoperatively and 24 hours postoperativelyPeripheral perfusion index measured in percent and total blood loss in mL
Association between total hemoglobin (SpHb) and total blood lossPreoperatively, 6 hours postoperatively and 24 hours postoperativelySpHb measured as gram/deciliter and total blood loss measured in mL
Changes in C-Reactive Protein (CRP)Preoperatively, 6 hours postoperatively and 24 hours postoperativelyMeasured in milligram/liter (mg/L)
Incidence of orthostatic intolerance during mobilizationPreoperatively, 6 hours postoperatively and 24 hours postoperativelySymptoms of orthostatic intolerance: dizziness, nausea, vomiting, blurry vision or syncope during mobilization
Association between total blood loss and incidence of orthostatic intolerancePreoperatively, 6 hours postoperatively and 24 hours postoperativelyBlood loss measured in mL. Symptoms of orthostatic intolerance: dizziness, nausea, vomiting, blurry vision or syncope during mobilization
Association between changes in C-Reactive Protein and total blood lossPreoperatively, 6 hours postoperatively and 24 hours postoperativelyC-Reactive Protein measured in mg/L and total blood loss measured in mL

Other

MeasureTime frameDescription
Intraoperativ estimation of bleedingIntraoperative at end of the surgical procedureMeasured by weighting gauze (gram)
Intraoperative bleedingIntraoperative at end of the surgical procedureMeasured by visual estimation in surgical drains (mL)

Countries

Denmark

Contacts

Primary ContactPuk Kristiansen, MD
puk.kristiansen@regionh.dk+4530291189
Backup ContactAna-Marija Hristovska, Senior registrar, Ph.D.
ana-marija.hristovska.02@regionh.dk

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026