Donor HepatectomyNCT04733547
Spectral Analysis of Central Venous Pressure Waveform
An observational study of Donor Hepatectomy and Central Venous Catheter, run by JongHae Kim at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Donor Hepatectomy, Central Venous Catheter, Hypovolemia
- What is being tested?
- Placement of a central venous catheter, Monitoring of central venous pressure and Furosemide-induced hypovolemia before graft procurement
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- 22 Feb 2021to 29 Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients are recruited from a tertiary university hospital
Who may be able to join
- American Society of Anesthesiologists physical status 1
- Scheduled for donor hepatectomy under general anesthesia
Who cannot join
- Arrhythmia
- Valvular heart disease
- Coronary artery disease
- Cerebrovascular disease
- Hypertension
- Diabetes mellitus
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Spectral Analysis of Central Venous Pressure Waveform in Patients Undergoing Donor Hepatectomy
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.
Read the 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.
- Conditions
- Donor Hepatectomy, Central Venous Catheter, Hypovolemia
- Being tested
- Placement of a central venous catheter, Monitoring of central venous pressure, Furosemide-induced hypovolemia before graft procurement, Replacement of fluid loss after graft procurement, Monitoring of stroke volume variation
- Medical subject headings
- Hypovolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placement of a central venous catheterProcedure or surgery
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 pressureDevice
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 procurementDrug
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 procurementDrug
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 variationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Donor hepatectomy | Live donors undergoing hepatectomy Receives: Procedure: Placement of a central venous catheter; Device: Monitoring of central venous pressure; Drug: Furosemide-induced hypovolemia before graft procurement; Drug: Replacement of fluid loss after graft procurement; Device: Monitoring of stroke volume variation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spectral power of central venous pressure corresponding to heart rate 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.
Measured: During 5 minutes before graft procurement
Secondary outcomes (20)
Spectral powers of central venous pressure corresponding to respiratory rate and heart rate 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.
Measured: During 5 minutes before the first dose of furosemide
Spectral powers of central venous pressure corresponding to respiratory rate and heart rate 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.
Measured: Between 30 and 35 minutes after surgical incision
Spectral power of central venous pressure corresponding to respiratory rate 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.
Measured: During 5 minutes before graft procurement
Spectral powers of central venous pressure corresponding to respiratory rate and heart rate 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.
Measured: During 5 minutes after administration of 6% hydroxyethyl starch
Stroke volume variation during 5 minutes before the first dose of furosemide
The median of the values calculated at a 20-second interval
Measured: During 5 minutes before the first dose of furosemide
Stroke volume index during 5 minutes before the first dose of furosemide
The median of the values calculated at a 20-second interval
Measured: During 5 minutes before the first dose of furosemide
Cardiac index during 5 minutes before the first dose of furosemide
The median of the values calculated at a 20-second interval
Measured: During 5 minutes before the first dose of furosemide
Stroke volume variation between 30 and 35 minutes after surgical incision
The median of the values calculated at a 20-second interval
Measured: Between 30 and 35 minutes after surgical incision
Stroke volume index between 30 and 35 minutes after surgical incision
The median of the values calculated at a 20-second interval
Measured: Between 30 and 35 minutes after surgical incision
Cardiac index between 30 and 35 minutes after surgical incision
The median of the values calculated at a 20-second interval
Measured: Between 30 and 35 minutes after surgical incision
Stroke volume variation during 5 minutes before graft procurement
The median of the values calculated at a 20-second interval
Measured: During 5 minutes before graft procurement
Stroke volume index during 5 minutes before graft procurement
The median of the values calculated at a 20-second interval
Measured: During 5 minutes before graft procurement
Cardiac index during 5 minutes before graft procurement
The median of the values calculated at a 20-second interval
Measured: During 5 minutes before graft procurement
Stroke volume variation during 5 minutes after administration of 6% hydroxyethyl starch
The median of the values calculated at a 20-second interval
Measured: During 5 minutes after administration of 6% hydroxyethyl starch
Stroke volume index during 5 minutes after administration of 6% hydroxyethyl starch
The median of the values calculated at a 20-second interval
Measured: During 5 minutes after administration of 6% hydroxyethyl starch
Cardiac index during 5 minutes after administration of 6% hydroxyethyl starch
The median of the values calculated at a 20-second interval
Measured: During 5 minutes after administration of 6% hydroxyethyl starch
Total dose of furosemide
The total dose of furosemide used for the promotion of diuresis
Measured: At graft procurement
Urine output at graft procurement
The total amount of urine output between the placement of urinary catheter and graft procurement
Measured: At graft procurement
Total urine output at the end of surgery
The total amount of urine output at the end of surgery
Measured: At the end of surgery
Intraoperative blood loss
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
Measured: 1 day after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2021
- Study start22 Feb 2021
- Primary completion29 Nov 2023
- Study completion29 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Donor HepatectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- JongHae Kim
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, JongHae Kim, Daegu Catholic University Medical Center
- Investigators
- Jonghae Kim, M.D., Principal investigator, Daegu Catholic University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04733547
- Sponsor's protocol ID
- CR-21-007
- Status last verified
- Dec 2023
- First submitted
- 26 Jan 2021
- Last updated
- 19 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 24901895Hocking 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.
PubMed 27070329Hocking 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.
PubMed 29028929Sileshi 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.
PubMed 25862041
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spectral Analysis of Central Venous Pressure Waveform in Patients Undergoing Donor Hepatectomy
- ClinicalTrials.gov ID
- NCT04733547
- Acronym / sponsor ID
- CR-21-007
- Conditions
- Donor Hepatectomy, Central Venous Catheter, Hypovolemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- JongHae KimUniversity, hospital or other
- Study start
- 22 Feb 2021 (actual)
- Primary completion
- 29 Nov 2023 (actual)
- Study completion
- 29 Nov 2023 (actual)
- First posted
- 2 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Donor hepatectomy | – | Procedure: Placement of a central venous catheter, Device: Monitoring of central venous pressure, Drug: Furosemide-induced hypovolemia before graft procurement, Drug: Replacement of fluid loss after graft procurement, Device: Monitoring of stroke volume variationLive donors undergoing hepatectomy |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients are recruited from a tertiary university hospital
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists physical status 1
- Scheduled for donor hepatectomy under general anesthesia
Key exclusion criteria (14 listed)
- Arrhythmia
- Valvular heart disease
- Coronary artery disease
- Cerebrovascular disease
- Hypertension
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placement of a central venous catheterThe 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. | Procedure or surgery | Donor hepatectomy |
| Monitoring of central venous pressureFollowing 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. | Device | Donor hepatectomy |
| Furosemide-induced hypovolemia before graft procurementPatients 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. | Drug | Donor hepatectomy |
| Replacement of fluid loss after graft procurementImmediately 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. | Drug | Donor hepatectomy |
| Monitoring of stroke volume variationFollowing 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. | Device | Donor hepatectomy |
Primary outcome
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.
20 secondary outcomes
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
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
Spectral power of central venous pressure corresponding to respiratory rate during 5 minutes before graft procurement
Time frame: During 5 minutes before graft procurement
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
Stroke volume variation during 5 minutes before the first dose of furosemide
Time frame: During 5 minutes before the first dose of furosemide
Stroke volume index during 5 minutes before the first dose of furosemide
Time frame: During 5 minutes before the first dose of furosemide
Cardiac index during 5 minutes before the first dose of furosemide
Time frame: During 5 minutes before the first dose of furosemide
Stroke volume variation between 30 and 35 minutes after surgical incision
Time frame: Between 30 and 35 minutes after surgical incision
Stroke volume index between 30 and 35 minutes after surgical incision
Time frame: Between 30 and 35 minutes after surgical incision
Cardiac index between 30 and 35 minutes after surgical incision
Time frame: Between 30 and 35 minutes after surgical incision
Stroke volume variation during 5 minutes before graft procurement
Time frame: During 5 minutes before graft procurement
Stroke volume index during 5 minutes before graft procurement
Time frame: During 5 minutes before graft procurement
Cardiac index during 5 minutes before graft procurement
Time frame: During 5 minutes before graft procurement
Stroke volume variation during 5 minutes after administration of 6% hydroxyethyl starch
Time frame: During 5 minutes after administration of 6% hydroxyethyl starch
Stroke volume index during 5 minutes after administration of 6% hydroxyethyl starch
Time frame: During 5 minutes after administration of 6% hydroxyethyl starch
Cardiac index during 5 minutes after administration of 6% hydroxyethyl starch
Time frame: During 5 minutes after administration of 6% hydroxyethyl starch
Total dose of furosemide
Time frame: At graft procurement
Urine output at graft procurement
Time frame: At graft procurement
Total urine output at the end of surgery
Time frame: At the end of surgery
Intraoperative blood loss
Time frame: 1 day after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2023.
- Background: PubMed 24901895Alian 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.
- Background: PubMed 27070329Hocking 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.
- Background: PubMed 29028929Hocking 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.
- Background: PubMed 25862041Sileshi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonghae Kim, M.D. principal investigator
Daegu Catholic University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Donor Hepatectomy and Central Venous Catheter, run by JongHae Kim at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spectral power of central venous pressure corresponding to heart rate during 5 minutes before graft procurement (time frame: During 5 minutes before graft procurement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04733547, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2023.