Intraoperative ComplicationsPhase 4NCT00308100
Hydroxyethyl Starch (130/0.4) for Intravascular Volume Therapy in Liver Transplantation
A Phase 4 study testing Hydroxyethylstarch 130/0.4 and 5% Albumin in people with Intraoperative Complications, run by Fresenius Kabi at 1 site in China.
Trial summary
There are no standardized plasma volume replacement protocols during liver transplantation surgery. The current study is designed to compare efficacy, safety, and costs of perioperative volume replacement with Voluven (Hydroxyethyl starch 130/0.4) and albumin in patients undergoing liver transplantation. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Intraoperative Complications
- What is being tested?
- Hydroxyethylstarch 130/0.4 and 5% Albumin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteChina
- Study dates
- Oct 2005to Jul 2008
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18-65 years, male or female
- Elective liver transplantation
- United Network for Organ Sharing (UNOS) Level 2A/B or 3
- Serum albumin ≥ 30 g/L
- Comprehend all the procedures of this study
- Willing and able to give informed consent
Who cannot join
- Uncontrolled exo-hepatic malignant carcinomas
- Uncontrollable infections (including HIV infection)
- Need support of artificial liver or kidney, ventilator-dependant, coma or unstable hemodynamically
- Patients with a history of hypersensitivity to hydroxyethyl starch or albumin
- Urinary output less than 500 ml within 24 hours after operation
- Patients with intracranial bleeding
Show all 10Show fewer
- Patients with other colloids for treating hypovolemia
- Patients with pulmonary edema
- Pregnant women or females of childbearing potential and lactating mothers
- Patients who are participating in other drug studies or who receive other investigational drugs within 30 days prior to the present study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Randomized, Open-Label, Parallel-Group, Albumin-Controlled Phase IV Study to Evaluate the Efficacy and Safety of Hydroxyethyl Starch (130/0.4) for Intravascular Volume Therapy in Patients Undergoing Liver Transplantation
There are no standardized plasma volume replacement protocols during liver transplantation surgery. The current study is designed to compare efficacy, safety, and costs of perioperative volume replacement with Voluven (Hydroxyethyl starch 130/0.4) and albumin in patients undergoing liver transplantation.
Read the detailed description
End-stage liver disease is one of the major diseases leading to death. With advancement of transplantation surgery and perioperative anesthesia management, liver transplantation has become an effective method to recover patients' liver function, thus saving their lives and improving their quality of life. Serious disorders of fluid balance, such as blood coagulation dysfunction, electrolyte disequilibrium, hypoalbuminaemia, low hematocrit, low hemoglobin and acid-base imbalance etc. exist in end stage cirrhosis patients with liver transplantation. Such abnormalities in the internal milieu could cause or worsen cardiovascular and pulmonary dysfunction, thus making perioperative management more difficult.
Albumin and blood plasma are conventionally used as plasma volume expanders in clinical practice. At the same time, the level of albumin concentration is also used as an important criterion of prognosis. When the level of albumin concentration in serum is below 35 g/L, postoperative mortality rates and complications will increase significantly. In fact, it has been the focus of debate for many years whether albumin should be used for volume replacement in critically ill patients. Boldt and his colleagues demonstrated that albumin has little positive influence on the prognosis of critically ill patients. However, Shwe deemed albumin beneficial to critically ill patients. Simon suggested that albumin is given mainly for treating hypovolemia instead of increasing the level of albumin concentration in serum. However, at the same time, he admitted there is no advantages of albumin in comparison to other colloid solutions and, furthermore, it is more expensive.
Voluven (130/0.4) is a medium molecular weight hydroxyethyl starch (HES) produced by Beijing Fresenius Kabi Pharmaceutical Co., Ltd. It is a novel HES preparation with optimized molecular weight and molecule distribution, has a lower degree of substitution (DS) (0.4), and a narrower molecular distribution profile (C2/C6) than other available HES specifications which make it more suitable for volume replacement therapy. Some studies have revealed that Voluven (130/0.4) has a comparable efficacy with HAES-steril (average molecular weight 200.000 dalton, degree of substitution 0.5). Because of its improved pharmacological profile, Voluven (130/0.4) is used to avoid capillary vessel leakage and improve oxygenation of tissues. In addition, Voluven (130/0.4) does not accumulate in plasma or tissues even after multiple dosing (maximal dose 50 ml/kg), and has an improved HES safety profile in terms of coagulation and kidney function.
The current study is designed to assess the efficacy, safety, and pharmaceutical economics characteristic of perioperative volume replacement with Voluven (130/0.4) in patients undergoing liver transplantation compared with patients who received volume therapy with albumin. The objective of this study is to supply appropriate regimens for patients undergoing liver transplantation, considering clinical efficacy, safety, and costs.
- Conditions
- Intraoperative Complications
- Being tested
- Hydroxyethylstarch 130/0.4, 5% Albumin
- Keywords
- Liver Transplantation
- Medical subject headings
- Intraoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydroxyethylstarch 130/0.4Drug
Also called HES 130/0.4, Hydroxyethyl starch 130/0.4
HES 130/0.4, administered intra- and perioperatively, max. daily dose: 33ml/kg BW; if needed, additionally albumin is administered (ratio crystalloid to colloid= 1:1)
5% AlbuminDrug
5% albumin, administered intra- and perioperatively
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Hydroxyethylstarch 130/0.4 |
| 2 | Active comparator | Not described Receives: Drug: 5% Albumin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemodynamics
Measured: From pre-operative period till discharged from hospital
Secondary outcomes (2)
Child-Turcotte-Pugh (CTP) score
Measured: From pre-operative period till discharged from hospital
Model for End-Stage Liver Disease (MELD) score
Measured: From pre-operative period till discharged from hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2006 (estimated)
- Study startOct 2005
- Primary completionJul 2008
- Study completionJul 2008
Why it stopped: Study is prematurely ended due to poor patient recruitment rate.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraoperative ComplicationsStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fresenius Kabi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Xisheng Leng, MD, Principal investigator, People's University of Peking University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00308100
- Sponsor's protocol ID
- BFP502
- Status last verified
- Jan 2009
- First submitted
- 28 Mar 2006
- Last updated
- 15 Jan 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Open-Label, Parallel-Group, Albumin-Controlled Phase IV Study to Evaluate the Efficacy and Safety of Hydroxyethyl Starch (130/0.4) for Intravascular Volume Therapy in Patients Undergoing Liver Transplantation
- ClinicalTrials.gov ID
- NCT00308100
- Acronym / sponsor ID
- BFP502
- Conditions
- Intraoperative Complications
- Keywords
- Liver Transplantation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study is prematurely ended due to poor patient recruitment rate.
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Fresenius KabiIndustry (pharma, biotech, devices)
- Study start
- Oct 2005
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 29 Mar 2006 (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.
There are no standardized plasma volume replacement protocols during liver transplantation surgery. The current study is designed to compare efficacy, safety, and costs of perioperative volume replacement with Voluven (Hydroxyethyl starch 130/0.4) and albumin in patients undergoing liver transplantation.
Detailed description
End-stage liver disease is one of the major diseases leading to death. With advancement of transplantation surgery and perioperative anesthesia management, liver transplantation has become an effective method to recover patients' liver function, thus saving their lives and improving their quality of life. Serious disorders of fluid balance, such as blood coagulation dysfunction, electrolyte disequilibrium, hypoalbuminaemia, low hematocrit, low hemoglobin and acid-base imbalance etc. exist in end stage cirrhosis patients with liver transplantation. Such abnormalities in the internal milieu could cause or worsen cardiovascular and pulmonary dysfunction, thus making perioperative management more difficult.
Albumin and blood plasma are conventionally used as plasma volume expanders in clinical practice. At the same time, the level of albumin concentration is also used as an important criterion of prognosis. When the level of albumin concentration in serum is below 35 g/L, postoperative mortality rates and complications will increase significantly. In fact, it has been the focus of debate for many years whether albumin should be used for volume replacement in critically ill patients. Boldt and his colleagues demonstrated that albumin has little positive influence on the prognosis of critically ill patients. However, Shwe deemed albumin beneficial to critically ill patients. Simon suggested that albumin is given mainly for treating hypovolemia instead of increasing the level of albumin concentration in serum. However, at the same time, he admitted there is no advantages of albumin in comparison to other colloid solutions and, furthermore, it is more expensive.
Voluven (130/0.4) is a medium molecular weight hydroxyethyl starch (HES) produced by Beijing Fresenius Kabi Pharmaceutical Co., Ltd. It is a novel HES preparation with optimized molecular weight and molecule distribution, has a lower degree of substitution (DS) (0.4), and a narrower molecular distribution profile (C2/C6) than other available HES specifications which make it more suitable for volume replacement therapy. Some studies have revealed that Voluven (130/0.4) has a comparable efficacy with HAES-steril (average molecular weight 200.000 dalton, degree of substitution 0.5). Because of its improved pharmacological profile, Voluven (130/0.4) is used to avoid capillary vessel leakage and improve oxygenation of tissues. In addition, Voluven (130/0.4) does not accumulate in plasma or tissues even after multiple dosing (maximal dose 50 ml/kg), and has an improved HES safety profile in terms of coagulation and kidney function.
The current study is designed to assess the efficacy, safety, and pharmaceutical economics characteristic of perioperative volume replacement with Voluven (130/0.4) in patients undergoing liver transplantation compared with patients who received volume therapy with albumin. The objective of this study is to supply appropriate regimens for patients undergoing liver transplantation, considering clinical efficacy, safety, and costs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Hydroxyethylstarch 130/0.4 |
| 2 | Active comparator | Drug: 5% Albumin |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged 18-65 years, male or female
- Elective liver transplantation
- United Network for Organ Sharing (UNOS) Level 2A/B or 3
- Serum albumin ≥ 30 g/L
- Comprehend all the procedures of this study
Key exclusion criteria (10 listed)
- Uncontrolled exo-hepatic malignant carcinomas
- Uncontrollable infections (including HIV infection)
- Need support of artificial liver or kidney, ventilator-dependant, coma or unstable hemodynamically
- Patients with a history of hypersensitivity to hydroxyethyl starch or albumin
- Urinary output less than 500 ml within 24 hours after operation
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 |
|---|---|---|
| Hydroxyethylstarch 130/0.4Also: HES 130/0.4, Hydroxyethyl starch 130/0.4HES 130/0.4, administered intra- and perioperatively, max. daily dose: 33ml/kg BW; if needed, additionally albumin is administered (ratio crystalloid to colloid= 1:1) | Drug | 1 |
| 5% Albumin5% albumin, administered intra- and perioperatively | Drug | 2 |
Primary outcome
Hemodynamics
Time frame: From pre-operative period till discharged from hospital
2 secondary outcomes
Child-Turcotte-Pugh (CTP) score
Time frame: From pre-operative period till discharged from hospital
Model for End-Stage Liver Disease (MELD) score
Time frame: From pre-operative period till discharged from hospital
Results and safety
The study was stopped early (reason given: Study is prematurely ended due to poor patient recruitment rate.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2009.
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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.
Xisheng Leng, MD principal investigator
People's University of Peking University
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 Hydroxyethylstarch 130/0.4 and 5% Albumin in people with Intraoperative Complications, run by Fresenius Kabi at 1 site in China.
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 6 inclusion and 10 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: stopped early, as of the sponsor's last update on 15 Jan 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 China. 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 was stopped early (reason given: Study is prematurely ended due to poor patient recruitment rate.). Results are not available in the source record.
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?
Hemodynamics (time frame: From pre-operative period till discharged from hospital). 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 15 Jan 2009.