CVP and SVV During Living Donor HepatectomyNCT02033967
Vasodilator-induced Hypovolemia in Living Liver Donors
A study testing vasodilator induced hypovolemia in people with CVP and SVV During Living Donor Hepatectomy and Surgical Field Grade (Condition of Surgical Field; Bleeding, Tension of the IVC), run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Induced hypovolemia is known to improve surgical field during living donor hepatectomy. This procedure is conventionally guided by monitoring the central venous pressure (CVP). Stroke volume variation (SVV) is a novel method to substitute with CVP to monitor cardiac preload. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- CVP and SVV During Living Donor Hepatectomy, Surgical Field Grade (Condition of Surgical Field; Bleeding, Tension of the IVC)
- What is being tested?
- vasodilator induced hypovolemia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2014to Jan 2015
- Phase
- Interventional
- 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
Who may be able to join
- adult (20-60 yr)
- elective living liver donors
Who cannot join
- not obtained informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Vasodilator-induced Hypovolemia in Living Liver Donors: Central Venous Pressure-guided vs Stroke Volume Variation-guided Technique
Induced hypovolemia is known to improve surgical field during living donor hepatectomy. This procedure is conventionally guided by monitoring the central venous pressure (CVP). Stroke volume variation (SVV) is a novel method to substitute with CVP to monitor cardiac preload. The investigators try to evaluate the relationship between CVP and SVV during CVP-guided vasodilator induced hypovolemia (validation study). Then, feasibility of vasodilator induced hypovolemia using the SVV calculated from the validation study will be tested (feasibility study).
Read the detailed description
This is a 2-phases study.
first phase validation study : Evaluation of the relationship between CVP and SVV during CVP-guided vasodilator induced hypovolemia
second phase feasibility study
: Comparison of the surgical field grade between validation study group(CVP guided group) and feasibility study group(SVV guided group)
- Conditions
- CVP and SVV During Living Donor Hepatectomy, Surgical Field Grade (Condition of Surgical Field; Bleeding, Tension of the IVC)
- Being tested
- vasodilator induced hypovolemia
- Keywords
- liver donor, hepatectomy, vasodilator, central venous pressure, stroke volume variation
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vasodilator induced hypovolemiaProcedure or surgery
Also called Milrinone induced hypovolemia
| Study group | Role | What they receive |
|---|---|---|
| CVP | Active comparator | Central venous pressure-guided vasodilator-induced hypovolemia Receives: Procedure: vasodilator induced hypovolemia |
| SVV | Experimental | stroke volume variation-guided vasodilator-induced hypovolemia Receives: Procedure: vasodilator induced hypovolemia |
What is being measured
The primary outcome is the main question the study is designed to answer.
target value of SVV
Target value of SVV is calculated from the linear regression equation that was calculated from scatter plot made with CVP and SVV values during CVP-guided vasodilator induced hypovolemia (validation study).
Measured: during living donor hepatectomy
Secondary outcomes (3)
surgical field
<4 point scale> Grade l: Very lax IVC and hepatic veins, minimal bleeding at resection plane, very easy to operate Grade ll: Lax IVC and hepatic veins, a little bleeding at resection plane, easy to operate Grade lll: Tense IVC and hepatic veins, appreciable bleeding at resection plane, somewhat difficult to operate Grade lV: Very tense IVC and hepatic veins, profuse bleeding at resection plane, very difficult to operate
Measured: during living donor hepatectomy
use of inotropics
Measured: during living donor hepatectomy
estimated blood loss
Measured: during living donor hepatectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CVP and SVV During Living Donor HepatectomyStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chul-Woo Jung, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02033967
- Sponsor's protocol ID
- MLN_SVV_CVP
- Status last verified
- Apr 2016
- First submitted
- 8 Jan 2014
- Last updated
- 25 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lee J, Kim WH, Ryu HG, Lee HC, Chung EJ, Yang SM, Jung CW. Stroke Volume Variation-Guided Versus Central Venous Pressure-Guided Low Central Venous Pressure With Milrinone During Living Donor Hepatectomy: A Randomized Double-Blinded Clinical Trial. Anesth Analg. 2017 Aug;125(2):423-430. doi: 10.1213/ANE.0000000000002197.
PubMed 28632543
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vasodilator-induced Hypovolemia in Living Liver Donors: Central Venous Pressure-guided vs Stroke Volume Variation-guided Technique
- ClinicalTrials.gov ID
- NCT02033967
- Acronym / sponsor ID
- MLN_SVV_CVP
- Conditions
- CVP and SVV During Living Donor Hepatectomy, Surgical Field Grade (Condition of Surgical Field; Bleeding, Tension of the IVC)
- Keywords
- liver donor, hepatectomy, vasodilator, central venous pressure, stroke volume variation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jan 2015 (actual)
- First posted
- 13 Jan 2014 (estimated)
- 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.
Induced hypovolemia is known to improve surgical field during living donor hepatectomy. This procedure is conventionally guided by monitoring the central venous pressure (CVP). Stroke volume variation (SVV) is a novel method to substitute with CVP to monitor cardiac preload. The investigators try to evaluate the relationship between CVP and SVV during CVP-guided vasodilator induced hypovolemia (validation study). Then, feasibility of vasodilator induced hypovolemia using the SVV calculated from the validation study will be tested (feasibility study).
Detailed description
This is a 2-phases study.
first phase validation study : Evaluation of the relationship between CVP and SVV during CVP-guided vasodilator induced hypovolemia
second phase feasibility study
: Comparison of the surgical field grade between validation study group(CVP guided group) and feasibility study group(SVV guided group)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CVP | Active comparator | Procedure: vasodilator induced hypovolemiaCentral venous pressure-guided vasodilator-induced hypovolemia |
| SVV | Experimental | Procedure: vasodilator induced hypovolemiastroke volume variation-guided vasodilator-induced hypovolemia |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- adult (20-60 yr)
- elective living liver donors
Key exclusion criteria (1 listed)
- not obtained informed consent
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 |
|---|---|---|
| vasodilator induced hypovolemiaAlso: Milrinone induced hypovolemia | Procedure or surgery | CVP, SVV |
Primary outcome
target value of SVV
Time frame: during living donor hepatectomy
Target value of SVV is calculated from the linear regression equation that was calculated from scatter plot made with CVP and SVV values during CVP-guided vasodilator induced hypovolemia (validation study).
3 secondary outcomes
surgical field
Time frame: during living donor hepatectomy
use of inotropics
Time frame: during living donor hepatectomy
estimated blood loss
Time frame: during living donor hepatectomy
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 25 Apr 2016.
- Derived from this study: PubMed 28632543Lee J, Kim WH, Ryu HG, Lee HC, Chung EJ, Yang SM, Jung CW. Stroke Volume Variation-Guided Versus Central Venous Pressure-Guided Low Central Venous Pressure With Milrinone During Living Donor Hepatectomy: A Randomized Double-Blinded Clinical Trial. Anesth Analg. 2017 Aug;125(2):423-430. doi: 10.1213/ANE.0000000000002197.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vasodilator induced hypovolemia in people with CVP and SVV During Living Donor Hepatectomy and Surgical Field Grade (Condition of Surgical Field; Bleeding, Tension of the IVC), run by Seoul National University Hospital 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 1 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 25 Apr 2016. 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?
target value of SVV (time frame: during living donor hepatectomy). 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 NCT02033967, which also lists 1 linked publication.
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 25 Apr 2016.