Living Donor Liver TransplantationPhase 4NCT04184401
Effect of Ascites Replacement Strategy on Time to 1st Flatus After LDLT
A Phase 4 study testing Ascites replacement with albumin and hartmann's solution and Ascites replacement with hartmann's solution in people with Living Donor Liver Transplantation, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The aim of this study is to evaluate difference in the rate of recovery of intestinal motility according to different ascites replacement strategy after living donor liver transplantation. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Living Donor Liver Transplantation
- What is being tested?
- Ascites replacement with albumin and hartmann's solution and Ascites replacement with hartmann's solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jan 2020to 30 Nov 2021
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (19 years or older)
- Elective living donor liver transplantation
Who cannot join
- Previous abdominal surgery
- Renal failure requiring renal replacement therapy
- Contraindications for 5% albumin use
- Condition with potential risk caused by increased circulating plasma (heart failure, renal failure combined with oliguria, pulmonary edema)
- Hemolytic anemia
- Contraindications for Hartmann solution
Show all 9Show fewer
- Progressive lactic acidosis
- Hypervolemia
- Hypernatremia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Albumin Administration Strategy for Ascites Replacement on Time to 1st Flatus After Liver Transplantation
The aim of this study is to evaluate difference in the rate of recovery of intestinal motility according to different ascites replacement strategy after living donor liver transplantation.
- Conditions
- Living Donor Liver Transplantation
- Being tested
- Ascites replacement with albumin and hartmann's solution, Ascites replacement with hartmann's solution
- Keywords
- Ascites, Albumin, Hartmann's solution, Postoperative ileus
- Medical subject headings
- Ascites
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ascites replacement with albumin and hartmann's solutionDrug
Also called Experimental
Combined strategy for ascites replacement
- 30% of ascites: replacement with 5% albumin
- 40% of ascites: replacement with Hartmann's solution
Ascites replacement with hartmann's solutionDrug
Also called No intervention
Hartmann's solution only strategy for ascites replacement
- 70% of ascites: replacement with Hartmann's solution
| Study group | Role | What they receive |
|---|---|---|
| Replacement with albumin | Experimental | 1. Check drain amount every 4 hour after SICU admission
2. Replacement of 70% of drainage from previous 4 hours over next 4 hours
* 30% of the drainage with 5% albumin
* 40% of drainage with Hartmann's solution
* If, serum K + level> 5mEq/L, replace with 0.9% saline instead of Hartmann solution
* If, serum albumin level is below 2.6 g/dL, inject 100mL of 20% albumin Receives: Drug: Ascites replacement with albumin and hartmann's solution |
| Replacement with Hartmann's solution | Active comparator | 1. Check drain amount every 4 hour after SICU admission
2. Replacement of 70% of drainage from previous 4 hours with Hartmann's solution over next 4 hours
* If, serum K + level> 5mEq/L, replace with 0.9% saline instead of Hartmann solution
* If, serum albumin level is below 2.6 g/dL, inject 100mL of 20% albumin Receives: Drug: Ascites replacement with hartmann's solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to 1st flatus
Interval between SICU admission and 1st flatus
Measured: within 4 weeks
Time to 1st diet
Interval between SICU admission and 1st diet
Measured: within 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2019
- Study start1 Jan 2020
- Primary completion30 Nov 2021
- Study completion30 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Living Donor Liver TransplantationStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- GC Pharma
- Responsible party
- Principal investigator, Ho Geol Ryu, Seoul National University Hospital
- Investigators
- Ho Geol Ryu, MD, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04184401
- Sponsor's protocol ID
- H-1902-077-1011
- Status last verified
- Jul 2023
- First submitted
- 12 Nov 2019
- Last updated
- 12 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Albumin Administration Strategy for Ascites Replacement on Time to 1st Flatus After Liver Transplantation
- ClinicalTrials.gov ID
- NCT04184401
- Acronym / sponsor ID
- H-1902-077-1011
- Conditions
- Living Donor Liver Transplantation
- Keywords
- Ascites, Albumin, Hartmann's solution, Postoperative ileus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- GC Pharma
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 3 Dec 2019 (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 aim of this study is to evaluate difference in the rate of recovery of intestinal motility according to different ascites replacement strategy after living donor liver transplantation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Replacement with albumin | Experimental | Drug: Ascites replacement with albumin and hartmann's solution1. Check drain amount every 4 hour after SICU admission 2. Replacement of 70% of drainage from previous 4 hours over next 4 hours * 30% of the drainage with 5% albumin * 40% of drainage with Hartmann's solution * If, serum K + level> 5mEq/L, replace with 0.9% saline instead of Hartmann solution * If, serum albumin level is below 2.6 g/dL, inject 100mL of 20% albumin |
| Replacement with Hartmann's solution | Active comparator | Drug: Ascites replacement with hartmann's solution1. Check drain amount every 4 hour after SICU admission 2. Replacement of 70% of drainage from previous 4 hours with Hartmann's solution over next 4 hours * If, serum K + level> 5mEq/L, replace with 0.9% saline instead of Hartmann solution * If, serum albumin level is below 2.6 g/dL, inject 100mL of 20% albumin |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults (19 years or older)
- Elective living donor liver transplantation
Key exclusion criteria (9 listed)
- Previous abdominal surgery
- Renal failure requiring renal replacement therapy
- Contraindications for 5% albumin use
- Contraindications for Hartmann solution
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 |
|---|---|---|
| Ascites replacement with albumin and hartmann's solutionAlso: ExperimentalCombined strategy for ascites replacement * 30% of ascites: replacement with 5% albumin * 40% of ascites: replacement with Hartmann's solution | Drug | Replacement with albumin |
| Ascites replacement with hartmann's solutionAlso: No interventionHartmann's solution only strategy for ascites replacement - 70% of ascites: replacement with Hartmann's solution | Drug | Replacement with Hartmann's solution |
Primary outcome
Time to 1st flatus
Time frame: within 4 weeks
Interval between SICU admission and 1st flatus
Time to 1st diet
Time frame: within 4 weeks
Interval between SICU admission and 1st diet
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 12 Jul 2023.
- Individual participant dataSharing planned: No
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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.
Ho Geol Ryu, MD, PhD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ascites replacement with albumin and hartmann's solution and Ascites replacement with hartmann's solution in people with Living Donor Liver Transplantation, 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 9 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 12 Jul 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Time to 1st flatus (time frame: within 4 weeks). The study lists 2 primary outcomes in all. 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 12 Jul 2023.