HepatectomyNCT00966745
Milrinone During Living Donor Hepatectomy
A study testing milrinone in people with Hepatectomy, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Maintaining a low central venous pressure during living donor hepatectomy is routine practice. The investigators tried to test the hypothesis that using milrinone to maintain a low central venous pressure (CVP) during is associated with a superior surgical field and less blood loss. Read more about this study
- Who is it for?
- Ages 19 to 55 years
- Conditions the study is for
- Hepatectomy
- What is being tested?
- milrinone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2008to Dec 2008
- 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 19 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Living liver donors
Who cannot join
- Donors with concurrent cardiac, pulmonary, and urologic disease
- Hepatectomy performed laparoscopically
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Milrinone During Living Donor Hepatectomy Using a Low Central Venous Pressure Technique
Maintaining a low central venous pressure during living donor hepatectomy is routine practice. The investigators tried to test the hypothesis that using milrinone to maintain a low central venous pressure (CVP) during is associated with a superior surgical field and less blood loss.
- Conditions
- Hepatectomy
- Being tested
- milrinone, placebo
- Keywords
- surgical field condition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
milrinoneDrug
placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| milrinone | Active comparator | milrinone infusion Receives: Drug: milrinone |
| placebo | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
condition of surgical field
Measured: intraoperative period (from the start of surgery to end of living donor hepatectomy)
Secondary outcomes (1)
the use of vasopressor and diuretics to maintain hemodynamic stability and low CVP status, respectively
Measured: intraoperative period (from the start of surgery to end of 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 posted27 Aug 2009 (estimated)
- Study startJan 2008
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00966745
- Sponsor's protocol ID
- mil_living_liver_donor
- Status last verified
- Aug 2009
- First submitted
- 13 Aug 2009
- Last updated
- 27 Aug 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Milrinone During Living Donor Hepatectomy Using a Low Central Venous Pressure Technique
- ClinicalTrials.gov ID
- NCT00966745
- Acronym / sponsor ID
- mil_living_liver_donor
- Conditions
- Hepatectomy
- Keywords
- surgical field condition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 27 Aug 2009 (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.
Maintaining a low central venous pressure during living donor hepatectomy is routine practice. The investigators tried to test the hypothesis that using milrinone to maintain a low central venous pressure (CVP) during is associated with a superior surgical field and less blood loss.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| milrinone | Active comparator | Drug: milrinonemilrinone infusion |
| placebo | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Living liver donors
Key exclusion criteria (2 listed)
- Donors with concurrent cardiac, pulmonary, and urologic disease
- Hepatectomy performed laparoscopically
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 |
|---|---|---|
| milrinone | Drug | milrinone |
| placebo | Drug | placebo |
Primary outcome
condition of surgical field
Time frame: intraoperative period (from the start of surgery to end of living donor hepatectomy)
1 secondary outcome
the use of vasopressor and diuretics to maintain hemodynamic stability and low CVP status, respectively
Time frame: intraoperative period (from the start of surgery to end of 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 27 Aug 2009.
Related trials for Hepatectomy
Recruiting
Implementation of a Pain Management Plan in Major Open Abdominal Surgeries.
Abdomen Cancer, Pancreas Adenocarcinoma (MSI-H)
Recruiting
Novel Method to Assess Hepatic Regeneration and Predict Hepatic Related Morbidity After Partial Hepatectomy
Liver Cancer Adult, Liver Regeneration
RecruitingPhase 1
Neoadjuvant Hypofractionated Stereotactic Body Radiation Therapy Prior to Surgery for Hepatocellular Carcinoma: a Feasibility Study.
Hepatocellular Carcinoma
RecruitingObservational study
Liver Transplantation for Colorectal Cancer
Colorectal Cancer, Liver Metastasis
Active, not recruiting
Prehabilitation Before Liver Surgery in Older Adults
Preoperative Prehabilitation in Older Adults Undergoing Hepatectomy
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 milrinone in people with Hepatectomy, 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 1 inclusion and 2 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 27 Aug 2009. 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. Some participants in this study may receive a placebo. 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?
condition of surgical field (time frame: intraoperative period (from the start of surgery to end of living donor hepatectomy)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Aug 2009.