Clinical trial NCT04733547: Spectral Analysis of Central Venous Pressure Waveform
Official title: Spectral Analysis of Central Venous Pressure Waveform in Patients Undergoing Donor Hepatectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Donor Hepatectomy
Central Venous Catheter
Hypovolemia
Lead sponsor: Daegu Catholic University Medical Center
Sponsor class: OTHER
First posted: 2021-02-02
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients are recruited from a tertiary university hospital

Brief summary: The use of central venous pressure has been abandoned for the assessment of intravascular volume status. The dynamic fluctuation of central venous pressure according to heart rate is quantitatively measured by spectral analysis of the central venous pressure waveform. Its clinical utility in the assessment of intravascular volume status is investigated.

Detailed description: The use of central venous pressure, which is one of the static preload indices, has been abandoned for the assessment of intravascular volume status because of its unreliability. The static preload indices have been replaced with dynamic preload indices, such as stroke volume variation or pulse pressure variation because the dynamic preload indices reliably predict fluid responsiveness and perform better than the static preload indices. However, the periodic component of central venous pressure, which goes with cardiac cycles, has not been investigated. The power corresponding to heart rate from spectral analysis of central venous pressure waveform represents the extent of the dynamic fluctuation of central venous pressure and is assumed to reflect intravascular volume status. It is hypothesized that the spectral power of central venous pressure corresponding to heart rate represents intravascular volume status.

Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists physical status 1
* Scheduled for donor hepatectomy under general anesthesia

Exclusion Criteria:

* Arrhythmia
* Valvular heart disease
* Coronary artery disease
* Cerebrovascular disease
* Hypertension
* Diabetes mellitus
* Renal insufficiency
* Pulmonary problems
* Any type of liver disease
* Body mass index greater than 35 kg/m2
* Human immunodeficiency virus infection
* Psychosocial problems
* Electrolyte imbalance
* Reoperation

Primary outcomes:
measure: Spectral power of central venous pressure corresponding to heart rate during 5 minutes before graft procurement
timeFrame: During 5 minutes before graft procurement
Secondary outcomes:
measure: Spectral powers of central venous pressure corresponding to respiratory rate and heart rate during 5 minutes before the first dose of furosemide
timeFrame: During 5 minutes before the first dose of furosemide
measure: Spectral powers of central venous pressure corresponding to respiratory rate and heart rate between 30 and 35 minutes after surgical incision
timeFrame: Between 30 and 35 minutes after surgical incision
measure: Spectral power of central venous pressure corresponding to respiratory rate during 5 minutes before graft procurement
timeFrame: During 5 minutes before graft procurement
measure: Spectral powers of central venous pressure corresponding to respiratory rate and heart rate during 5 minutes after administration of 6% hydroxyethyl starch
timeFrame: During 5 minutes after administration of 6% hydroxyethyl starch
measure: Stroke volume variation during 5 minutes before the first dose of furosemide
timeFrame: During 5 minutes before the first dose of furosemide
measure: Stroke volume index during 5 minutes before the first dose of furosemide
timeFrame: During 5 minutes before the first dose of furosemide
measure: Cardiac index during 5 minutes before the first dose of furosemide
timeFrame: During 5 minutes before the first dose of furosemide
measure: Stroke volume variation between 30 and 35 minutes after surgical incision
timeFrame: Between 30 and 35 minutes after surgical incision
measure: Stroke volume index between 30 and 35 minutes after surgical incision
timeFrame: Between 30 and 35 minutes after surgical incision
measure: Cardiac index between 30 and 35 minutes after surgical incision
timeFrame: Between 30 and 35 minutes after surgical incision
measure: Stroke volume variation during 5 minutes before graft procurement
timeFrame: During 5 minutes before graft procurement
measure: Stroke volume index during 5 minutes before graft procurement
timeFrame: During 5 minutes before graft procurement
measure: Cardiac index during 5 minutes before graft procurement
timeFrame: During 5 minutes before graft procurement
measure: Stroke volume variation during 5 minutes after administration of 6% hydroxyethyl starch
timeFrame: During 5 minutes after administration of 6% hydroxyethyl starch
measure: Stroke volume index during 5 minutes after administration of 6% hydroxyethyl starch
timeFrame: During 5 minutes after administration of 6% hydroxyethyl starch
measure: Cardiac index during 5 minutes after administration of 6% hydroxyethyl starch
timeFrame: During 5 minutes after administration of 6% hydroxyethyl starch
measure: Total dose of furosemide
timeFrame: At graft procurement
measure: Urine output at graft procurement
timeFrame: At graft procurement
measure: Total urine output at the end of surgery
timeFrame: At the end of surgery
measure: Intraoperative blood loss
timeFrame: 1 day after surgery
Other outcomes:
measure: Age
timeFrame: On arrival at the operating room
measure: Sex
timeFrame: On arrival at the operating room
measure: Height
timeFrame: The day before surgery
measure: Weight
timeFrame: The day before surgery
measure: Aspartate transaminase
timeFrame: The day before surgery
measure: Alanine transaminase
timeFrame: The day before surgery
measure: Blood urea nitrogen
timeFrame: The day before surgery
measure: Creatinine
timeFrame: The day before surgery
measure: Serum sodium level
timeFrame: The day before surgery
measure: Serum potassium level
timeFrame: The day before surgery
measure: Serum chloride level
timeFrame: The day before surgery
measure: Graft weight
timeFrame: At graft procurement
measure: Total amount of fluids
timeFrame: At the end of surgery
measure: Aspartate transaminase
timeFrame: 1 hour after surgery
measure: Alanine transaminase
timeFrame: 1 hour after surgery
measure: Blood urea nitrogen
timeFrame: 1 hour after surgery
measure: Creatinine
timeFrame: 1 hour after surgery
measure: Serum sodium level
timeFrame: 1 hour after surgery
measure: Serum potassium level
timeFrame: 1 hour after surgery
measure: Serum chloride
timeFrame: 1 hour after surgery
Locations:
city: Daegu
country: Korea, Republic of
facility: Daegu Catholic University Medical Center
Study officials:
affiliation: Daegu Catholic University Medical Center
name: Jonghae Kim, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Alian AA, Galante NJ, Stachenfeld NS, Silverman DG, Shelley KH. Impact of lower body negative pressure induced hypovolemia on peripheral venous pressure waveform parameters in healthy volunteers. Physiol Meas. 2014 Jul;35(7):1509-20. doi: 10.1088/0967-3334/35/7/1509. Epub 2014 Jun 5.
citation: Hocking KM, Sileshi B, Baudenbacher FJ, Boyer RB, Kohorst KL, Brophy CM, Eagle SS. Peripheral Venous Waveform Analysis for Detecting Hemorrhage and Iatrogenic Volume Overload in a Porcine Model. Shock. 2016 Oct;46(4):447-52. doi: 10.1097/SHK.0000000000000615.
citation: Hocking KM, Alvis BD, Baudenbacher F, Boyer R, Brophy CM, Beer I, Eagle S. Peripheral i.v. analysis (PIVA) of venous waveforms for volume assessment in patients undergoing haemodialysis. Br J Anaesth. 2017 Dec 1;119(6):1135-1140. doi: 10.1093/bja/aex271.
citation: Sileshi B, Hocking KM, Boyer RB, Baudenbacher FJ, Kohurst KL, Brophy CM, Eagle S. Peripheral venous waveform analysis for detecting early hemorrhage: a pilot study. Intensive Care Med. 2015 Jun;41(6):1147-8. doi: 10.1007/s00134-015-3787-0. Epub 2015 Apr 11. No abstract available.