Clinical trial NCT06888908: Changes in Perioperative Blood Volume and Fluid Distribution in Patients Undergoing Primary Total Hip Replacement.
Official title: Perioperative Change in Blood Volume and Fluid Distribution in Total Hip Arthroplasty
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hip Arthroplasty Replacement
Keywords: Blood loss
Blood volume
Lead sponsor: Copenhagen University Hospital, Hvidovre
Sponsor class: OTHER
First posted: 2025-03-21
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in total blood volume (TBV)
timeFrame: Preoperatively and 6 hours postoperatively
Secondary outcomes:
measure: Change in total blood volume (TBV)
timeFrame: Preoperatively and 24 hours postoperatively
measure: Changes in total hemoglobin mass (tHgb)
timeFrame: Preoperatively, 6 hours postoperatively and 24 hours postoperatively
measure: Changes in erythrocyte volume (EBV)
timeFrame: Preoperatively, 6 hours postoperatively and 24 hours postoperatively
measure: Changes in plasma volume (PV)
timeFrame: Preoperatively, 6 hours postoperatively and 24 hours postoperatively
measure: Changes in hematokrit (Ht)
timeFrame: Preoperatively, 6 hours postoperatively and 24 hours postoperatively
measure: Changes in hemoglobin (Hg) concentration
timeFrame: Preoperatively, 6 hours postoperatively and 24 hours postoperatively
measure: Changes in Total body water(TBW), intra-(ICF) and extracellular(ECF) fluid distribution
timeFrame: Preoperatively, 6 hours postoperatively and 24 hours postoperatively
measure: Changes in C-Reactive Protein (CRP)
timeFrame: Preoperatively, 6 hours postoperatively and 24 hours postoperatively
measure: Incidence of orthostatic intolerance during mobilization
timeFrame: Preoperatively, 6 hours postoperatively and 24 hours postoperatively
measure: Association between total blood loss and incidence of orthostatic intolerance
timeFrame: Preoperatively, 6 hours postoperatively and 24 hours postoperatively
measure: Association between changes in C-Reactive Protein and total blood loss
timeFrame: Preoperatively, 6 hours postoperatively and 24 hours postoperatively
measure: Association between peripheral perfusion index and total blood loss
timeFrame: Preoperatively, 6 hours postoperatively and 24 hours postoperatively
measure: Association between total hemoglobin (SpHb) and total blood loss
timeFrame: Preoperatively, 6 hours postoperatively and 24 hours postoperatively
Other outcomes:
measure: Intraoperativ estimation of bleeding
timeFrame: Intraoperative at end of the surgical procedure
measure: Intraoperative bleeding
timeFrame: Intraoperative at end of the surgical procedure
Locations:
city: Copenhagen
country: Denmark
facility: Hvidovre University Hospital
Study officials:
affiliation: Department of Anesthesiology and Intensive Care Medicine, Copenhagen University Hospital, Hvidovre
name: Nicolai Foss, Professor, Dr. Med.
role: STUDY_DIRECTOR
References: