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Completed

NCT Number: NCT04733547

Spectral Analysis of Central Venous Pressure Waveform

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.

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Key information

Conditions

Donor Hepatectomy Central Venous Catheter Hypovolemia Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Daegu Catholic University Medical Center

Daegu, 42472, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Placement of a central venous catheter

Procedure

The right internal jugular vein is located at the first rib level under ultrasound-guidance. Using an out-of-plane technique, a needle is introduced into the lumen of the vessel. The aspiration of blood into the syringe connected to the hub of the needle confirms the placement of the needle tip in the lumen. After the syringe is detached from the needle, a guidewire is advanced into the vessel lumen through the needle. A dilator is introduced over the guidewire and subsequently is removed. Then, a central venous catheter is introduced over the guidewire into the vessel lumen through the pathway expanded by the dilator. The catheter tip is placed in the superior vena cava by inserting the catheter as far as the distance between the edge of the right transverse process of the first thoracic vertebra and the carina, which is preoperatively measured on a posteroanterior chest radiograph.

Monitoring of central venous pressure

Device

Following the placement of a central venous catheter, a fluid-filled system for monitoring central venous pressure is connected to the proximal lumen of the catheter. The reference transducer is placed at the level of 4/5 of the anteroposterior diameter of the thorax.

Furosemide-induced hypovolemia before graft procurement

Drug

Patients fast from 10 pm the day before surgery. On the arrival at the operating room, an intravenous catheter for Plasmalyte infusion is placed into the right cephalic or basilic vein. The distal lumen of the central venous catheter is used for the infusion of 6% hydroxyethyl starch. Fluid requirements due to anesthesia, surgery, and no per os intake are not replaced by minimizing the administration of the fluids. Five minutes after the collection of the baseline data, 20 mg of furosemide is administered to promote diuresis for facilitating the venous outflow of the liver. An additional dose of furosemide 20 mg is given if the urine output is <1 ml/kg within 30 minutes after the first dose. Unless the second dose of furosemide produces >1 ml/kg of urine within 30 minutes, 40 mg of furosemide is administered. In the absence of effective diuresis (1 ml/kg within 30 minutes after each dose), the use of furosemide is abandoned and the patients are excluded from the study.

Replacement of fluid loss after graft procurement

Drug

Immediately after the graft procurement, 500 ml of 6% hydroxyethyl starch are infused over 25 minutes. Afterward, Plasmalyte is infused at a rate of 10 ml/min until the end of surgery.

Monitoring of stroke volume variation

Device

Following anesthesia induction, the right radial artery is catheterized. The catheter is connected to the EV1000 monitor (Edwards Lifesciences, Irvine, CA) through the FloTrac transducer (Edwards Lifesciences). The transducer is level with the one for central venous pressure monitoring. Using pulse contour analysis without external calibration, the stroke volume for each heartbeat is measured. At a 20-second interval, stroke volume variation is calculated as (maximum stroke volume - minimum stroke volume)/mean stroke volume.

Primary outcomes

  1. Spectral power of central venous pressure corresponding to heart rate during 5 minutes before graft procurement

    Time frame: During 5 minutes before graft procurement

    A band-pass filter (0.15-3 Hz) is applied to the 5 minute-long segment. The 5 minute-long segments are divided into 100 second-long segments overlapping 50% with each adjacent segment. Each segment is submitted to fast Fourier transformation. The spectral powers obtained from the periodograms of each segment are averaged. The integrated area corresponding to heart rate is the spectral power corresponding to heart rate.

Secondary outcomes

  1. Spectral powers of central venous pressure corresponding to respiratory rate and heart rate during 5 minutes before the first dose of furosemide

    Time frame: During 5 minutes before the first dose of furosemide

    A band-pass filter (0.15-3 Hz) is applied to the 5 minute-long segment. The 5 minute-long segments are divided into 100 second-long segments overlapping 50% with each adjacent segment. Each segment is submitted to fast Fourier transformation. The spectral powers obtained from the periodograms of each segment are averaged. The integrated areas corresponding to respiratory rate and heart rate are the spectral powers corresponding to respiratory rate and heart rate.

  2. Spectral powers of central venous pressure corresponding to respiratory rate and heart rate between 30 and 35 minutes after surgical incision

    Time frame: Between 30 and 35 minutes after surgical incision

    A band-pass filter (0.15-3 Hz) is applied to the 5 minute-long segment. The 5 minute-long segments are divided into 100 second-long segments overlapping 50% with each adjacent segment. Each segment is submitted to fast Fourier transformation. The spectral powers obtained from the periodograms of each segment are averaged. The integrated areas corresponding to respiratory rate and heart rate are the spectral powers corresponding to respiratory rate and heart rate.

  3. Spectral power of central venous pressure corresponding to respiratory rate during 5 minutes before graft procurement

    Time frame: During 5 minutes before graft procurement

    A band-pass filter (0.15-3 Hz) is applied to the 5 minute-long segment. The 5 minute-long segments are divided into 100 second-long segments overlapping 50% with each adjacent segment. Each segment is submitted to fast Fourier transformation. The spectral powers obtained from the periodograms of each segment are averaged. The integrated area corresponding to respiratory rate is the spectral power corresponding to respiratory rate.

  4. Spectral powers of central venous pressure corresponding to respiratory rate and heart rate during 5 minutes after administration of 6% hydroxyethyl starch

    Time frame: During 5 minutes after administration of 6% hydroxyethyl starch

    A band-pass filter (0.15-3 Hz) is applied to the 5 minute-long segment. The 5 minute-long segments are divided into 100 second-long segments overlapping 50% with each adjacent segment. Each segment is submitted to fast Fourier transformation. The spectral powers obtained from the periodograms of each segment are averaged. The integrated areas corresponding to respiratory rate and heart rate are the spectral powers corresponding to respiratory rate and heart rate.

  5. Stroke volume variation during 5 minutes before the first dose of furosemide

    Time frame: During 5 minutes before the first dose of furosemide

    The median of the values calculated at a 20-second interval

  6. Stroke volume index during 5 minutes before the first dose of furosemide

    Time frame: During 5 minutes before the first dose of furosemide

    The median of the values calculated at a 20-second interval

  7. Cardiac index during 5 minutes before the first dose of furosemide

    Time frame: During 5 minutes before the first dose of furosemide

    The median of the values calculated at a 20-second interval

  8. Stroke volume variation between 30 and 35 minutes after surgical incision

    Time frame: Between 30 and 35 minutes after surgical incision

    The median of the values calculated at a 20-second interval

  9. Stroke volume index between 30 and 35 minutes after surgical incision

    Time frame: Between 30 and 35 minutes after surgical incision

    The median of the values calculated at a 20-second interval

  10. Cardiac index between 30 and 35 minutes after surgical incision

    Time frame: Between 30 and 35 minutes after surgical incision

    The median of the values calculated at a 20-second interval

  11. Stroke volume variation during 5 minutes before graft procurement

    Time frame: During 5 minutes before graft procurement

    The median of the values calculated at a 20-second interval

  12. Stroke volume index during 5 minutes before graft procurement

    Time frame: During 5 minutes before graft procurement

    The median of the values calculated at a 20-second interval

  13. Cardiac index during 5 minutes before graft procurement

    Time frame: During 5 minutes before graft procurement

    The median of the values calculated at a 20-second interval

  14. Stroke volume variation during 5 minutes after administration of 6% hydroxyethyl starch

    Time frame: During 5 minutes after administration of 6% hydroxyethyl starch

    The median of the values calculated at a 20-second interval

  15. Stroke volume index during 5 minutes after administration of 6% hydroxyethyl starch

    Time frame: During 5 minutes after administration of 6% hydroxyethyl starch

    The median of the values calculated at a 20-second interval

  16. Cardiac index during 5 minutes after administration of 6% hydroxyethyl starch

    Time frame: During 5 minutes after administration of 6% hydroxyethyl starch

    The median of the values calculated at a 20-second interval

  17. Total dose of furosemide

    Time frame: At graft procurement

    The total dose of furosemide used for the promotion of diuresis

  18. Urine output at graft procurement

    Time frame: At graft procurement

    The total amount of urine output between the placement of urinary catheter and graft procurement

  19. Total urine output at the end of surgery

    Time frame: At the end of surgery

    The total amount of urine output at the end of surgery

  20. Intraoperative blood loss

    Time frame: 1 day after surgery

    Calculated as blood loss (ml) = [estimated blood volume*(preoperative hematocrit-postoperative hematocrit)]/mean between the 2 hematocrit values, where estimated blood volume (ml) = weight(kg)^0.425*height(cm)^0.725*0.007184*2217+age(years)*1.06 for female and weight(kg)^0.425*height(cm)^0.725*0.007184*3064-825 for male

Other outcomes

  1. Age

    Time frame: On arrival at the operating room

    Age at the time of surgery

  2. Sex

    Time frame: On arrival at the operating room

    Biological sex

  3. Height

    Time frame: The day before surgery

    Measured in cm

  4. Weight

    Time frame: The day before surgery

    Measured in kg

  5. Aspartate transaminase

    Time frame: The day before surgery

    Measured in U/L

  6. Alanine transaminase

    Time frame: The day before surgery

    Measured in U/L

  7. Blood urea nitrogen

    Time frame: The day before surgery

    Measured in mg/dl

  8. Creatinine

    Time frame: The day before surgery

    Measured in mg/dl

  9. Serum sodium level

    Time frame: The day before surgery

    Measured in mmol/L

  10. Serum potassium level

    Time frame: The day before surgery

    Measured in mmol/L

  11. Serum chloride level

    Time frame: The day before surgery

    Measured in mmol/L

  12. Graft weight

    Time frame: At graft procurement

    Measured in gram

  13. Total amount of fluids

    Time frame: At the end of surgery

    The total volume of colloids and crystalloids administered throughout the entire surgery

  14. Aspartate transaminase

    Time frame: 1 hour after surgery

    Measured in U/L

  15. Alanine transaminase

    Time frame: 1 hour after surgery

    Measured in U/L

  16. Blood urea nitrogen

    Time frame: 1 hour after surgery

    Measured in mg/dl

  17. Creatinine

    Time frame: 1 hour after surgery

    Measured in mg/dl

  18. Serum sodium level

    Time frame: 1 hour after surgery

    Measured in mmol/L

  19. Serum potassium level

    Time frame: 1 hour after surgery

    Measured in mmol/L

  20. Serum chloride

    Time frame: 1 hour after surgery

    Measured in mmol/L

Sponsors and collaborators

Lead sponsor

JongHae Kim

Other

Registry information

Official study title

Spectral Analysis of Central Venous Pressure Waveform in Patients Undergoing Donor Hepatectomy

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Feb 2, 2021
Registry last updated
Dec 19, 2023

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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