Patients Undergoing Liver TransplantationNCT02079350
Impact of %6 HES 130/0.4 and %4 Gelofusine Infusion on Kidney Function in the Living-donor Liver Transplantation
An observational study of Patients Undergoing Liver Transplantation, run by Turkiye Yuksek Ihtisas Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Although the negative impacts of colloid solutions with high molecular weight on renal functions, combination of lower molecular weight colloid varieties with crystalloid solutions and its use during intraoperative period have been subject to current research. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Patients Undergoing Liver Transplantation
- What is being tested?
- %6 HES and %4 Gelofusine
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2011to Dec 2013
- How long will I take part?
- 1 Month
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients undergoing living donor liver transplantation
Who may be able to join
- -Normal kidney function
Who cannot join
- anormal kidney function
- cadaveric transplantation
- emergency operation
- patients less than 18 years old
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Turkey Yuksek Ihtisas Education and Research Hospital, Anesthesiology Clinic
Ankara, 06550
About this study
Although the negative impacts of colloid solutions with high molecular weight on renal functions, combination of lower molecular weight colloid varieties with crystalloid solutions and its use during intraoperative period have been subject to current research. Since the first liver transplantation, pre-or post-transplantation renal problems are still among the main causes of mortality and morbidity. The aim of the study was to evaluate the effects of fluid replacement solutions used intraoperatively on renal functions in elective living-donor liver transplantation.This study was approved by the Ethics Committee of Hospital and all patients were informed and gave written consent. Participants were patients scheduled for elective living-donor liver transplantation. Patients with normal renal function were randomly allocated to infusion with 6% HES 130/0.4 (HES Group) and 4% Gelofusine (GEL Group). Blood samples were obtained before induction of anesthesia (baseline), at the end of the operation, and postoperative days 1 and 4. Different eGFR formulas using creatinine (MDRD, CKD-EPI, and Cockraud Gault) were used to calculate estimated glomerular filtration rates.
- Being tested
- %6 HES and %4 Gelofusine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
%6 HES and %4 GelofusineDrug
| Study group | Role | What they receive |
|---|---|---|
| %4 Gelofusine | patients administered %4 Gelofusine during liver transplantation Receives: Drug: %6 HES and %4 Gelofusine | |
| %6 HES | patients administered %6 HES during liver transplantation Receives: Drug: %6 HES and %4 Gelofusine |
What is being measured
The primary outcome is the main question the study is designed to answer.
renal dysfunction
Measured: 1 month
Secondary outcomes (1)
mortality
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2014 (estimated)
- Study startJan 2011
- Primary completionNov 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients Undergoing Liver TransplantationStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 36 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Turkiye Yuksek Ihtisas Education and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, aslı demir, Turkiye Yuksek Ihtisas Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02079350
- Sponsor's protocol ID
- 11739
- Status last verified
- Mar 2014
- First submitted
- 1 Mar 2014
- Last updated
- 5 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of %6 HES 130/0.4 and %4 Gelofusine Infusion on Kidney Function in the Living-donor Liver Transplantation
- ClinicalTrials.gov ID
- NCT02079350
- Acronym / sponsor ID
- 11739
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Turkiye Yuksek Ihtisas Education and Research HospitalOther government
- Study start
- Jan 2011
- Primary completion
- Nov 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 5 Mar 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.
Although the negative impacts of colloid solutions with high molecular weight on renal functions, combination of lower molecular weight colloid varieties with crystalloid solutions and its use during intraoperative period have been subject to current research. Since the first liver transplantation, pre-or post-transplantation renal problems are still among the main causes of mortality and morbidity. The aim of the study was to evaluate the effects of fluid replacement solutions used intraoperatively on renal functions in elective living-donor liver transplantation.This study was approved by the Ethics Committee of Hospital and all patients were informed and gave written consent. Participants were patients scheduled for elective living-donor liver transplantation. Patients with normal renal function were randomly allocated to infusion with 6% HES 130/0.4 (HES Group) and 4% Gelofusine (GEL Group). Blood samples were obtained before induction of anesthesia (baseline), at the end of the operation, and postoperative days 1 and 4. Different eGFR formulas using creatinine (MDRD, CKD-EPI, and Cockraud Gault) were used to calculate estimated glomerular filtration rates.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| %4 Gelofusine | – | Drug: %6 HES and %4 Gelofusinepatients administered %4 Gelofusine during liver transplantation |
| %6 HES | – | Drug: %6 HES and %4 Gelofusinepatients administered %6 HES during liver transplantation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients undergoing living donor liver transplantation
Key inclusion criteria (1 listed)
- -Normal kidney function
Key exclusion criteria (4 listed)
- anormal kidney function
- cadaveric transplantation
- emergency operation
- patients less than 18 years old
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 |
|---|---|---|
| %6 HES and %4 Gelofusine | Drug | %4 Gelofusine, %6 HES |
Primary outcome
renal dysfunction
Time frame: 1 month
1 secondary outcome
mortality
Time frame: 1 month
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 5 Mar 2014.
Related trials for Patients Undergoing Liver Transplantation
Not yet recruitingPhase 3
Targeted Versus Standard Peri-operative Antibiotic Prophylaxis in Patients Colonized With Carbapenemase Producing Enterobacterales Undergoing Liver Transplantation
Liver Transplant, Carbapenem-resistant Enterobacterales
Not yet recruiting
Patients With Hepatocellular Carcinoma (HCC)
Hepatocellular Carcinoma, Hepatocellular Cancer
Active, not recruitingPhase 1
18F-FSPG PET in Imaging Patients With Liver Cancer Before Undergoing Surgery or Transplant
Adult Hepatocellular Carcinoma, Resectable Hepatocellular Carcinoma
Recruiting
Evaluate the Performance of the Dexcom G7 Continuous Glucose Monitoring (CGM) System in Critically Ill Patients Undergoing Major Abdominal Surgery and Solid Organ Transplantation Which Require Blood Glucose Monitoring for Intensive Insulin Therapy.
CGM, Intensive Care (ICU)
Recruiting
Effects of Terlipressin and Somatostatin on Portal Pressure in Patients Undergoing Living Donor Liver Transplantation
Liver Transplantation, Portal Hypertension
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?
An observational study of Patients Undergoing Liver Transplantation, run by Turkiye Yuksek Ihtisas Education and Research Hospital at 1 site in Turkey (Türkiye).
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 4 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 5 Mar 2014. 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 Turkey (Türkiye). 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?
renal dysfunction (time frame: 1 month). 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 5 Mar 2014.