Postoperative ComplicationsPhase 4NCT00308126
Study to Evaluate the Effect of Hydroxyethyl Starch (HES) in Complications of Patients After Abdominal Surgery
A Phase 4 study testing Hydroxyethyl Starch 130/0.4 (Voluven) in people with Postoperative Complications, run by Fresenius Kabi at 1 site in China.
Trial summary
Purpose: To compare the incidence of post-surgery complications and evaluate relevant parameters within 28 days after an operation in HES (130/0.4) and albumin treated groups Study Design: Open-label, active controlled, parallel group, randomized, multi-center study. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Postoperative Complications
- What is being tested?
- Hydroxyethyl Starch 130/0.4 (Voluven)
- How many people
- 624 participants
- Where
- 1 siteChina
- Study dates
- Jun 2005to Sep 2006
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age from 18 to 75, male or female
- After abdominal operation of medium scale or above (including but not limited to: gastric cancer eradication, rectal cancer eradication, hepatic lobectomy, corpus and cauda pancreatectomy)
- Hemoglobin (Hb) no less than 70g/L; serum albumin no less than 30 g/L before operation
- Blood loss during operation no more than 2000 ml
Who cannot join
- Known to be allergic to HES or albumin
- Urine output less than 500 ml/24 hours
- Intra-cranial hemorrhage
- Liver transplantation
- Use colloid other than study drugs
- Lung edema
Show all 9Show fewer
- Pregnant, lactating female
- Participate in other clinical study within 30 days
- Poor compliance
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase IV, Open-Label, Randomized, Albumin-Controlled, Parallel Group, Multicenter Study to Evaluate the Effect of Medium Molecule HES (130/0.4) in Complications for Patients After Abdominal Surgery
Purpose: To compare the incidence of post-surgery complications and evaluate relevant parameters within 28 days after an operation in HES (130/0.4) and albumin treated groups
Study Design: Open-label, active controlled, parallel group, randomized, multi-center study. Per protocol, 624 patients required in 6 study centers.
Hypothesis: No difference in rate of postoperative (post-op) complications between HES and albumin groups
Read the detailed description
Since the application of surgical operations, postoperative complications have been the area surgeons explored the most. Though surgical technological advances make it possible for most patients to recover from an operation, the prevention and management of the postoperative complications are still important for surgeons.
Traditionally, the level of albumin is an important marker for the prognosis of the patient. When the level of albumin is below 35 g/L, the mortality rate and other complications will increase significantly, so albumin has become the widely used colloid liquid in fluid therapy for postoperative patients. Actually, the body cannot utilize exogenous albumin and it takes 6-7 days for the body to synthesize new albumin. There is dispute concerning whether albumin should be used in postoperative treatments for severely ill patients. The well-known SAFE study found there was no difference in the efficacy between albumin and crystalloids for severe patients in the 28-day observation time. A meta analysis of 24 studies involving 1419 patients came to the conclusion that administration of albumin could increase the mortality rate in patients. The high price of albumin is another target for extensive criticism.
On the other hand, maintaining colloid osmotic pressure at a certain level in the circulatory system is essential for postoperative patients to stabilize hemodynamics, reduce tissue edema, improve recovery, so it is beneficial for patients to replace albumin with Voluven (130/0.4). Voluven (130/0.4) is a medium-molecular-weight hydroxyethyl starch produced by Fresenius Kabi Pharmaceutical Co. Ltd, and is widely used clinically in volume replacement therapy. Its efficacy and safety are proved by its clinical practices, however, its effect in patients with postoperative complications is not clear. The study will compare the effect of Voluven (130/0.4) and albumin on the occurrence of postoperative complications in patients with an abdominal operation to provide guidance on selection of safe and economic volume replacement therapy for postoperative patients.
STUDY OBJECTIVES
To compare the effect of Voluven (130/0.4) to that of albumin for occurrence of postoperative complications in patients with abdominal surgery from the day of the operation to 28th day after the operation.
- Conditions
- Postoperative Complications
- Being tested
- Hydroxyethyl Starch 130/0.4 (Voluven)
- Keywords
- Abdominal operation
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydroxyethyl Starch 130/0.4 (Voluven)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of any postoperative complication stipulated in protocol within 28 days after abdominal operation
Secondary outcomes (1)
28th day after abdominal operation
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 startJun 2005
- Study completionSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative 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
- 624 participants
Sponsor and investigators
- Lead sponsor
- Fresenius Kabi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Yupei Zhao, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00308126
- Sponsor's protocol ID
- BFP501
- Status last verified
- Mar 2006
- First submitted
- 28 Mar 2006
- Last updated
- 11 Dec 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IV, Open-Label, Randomized, Albumin-Controlled, Parallel Group, Multicenter Study to Evaluate the Effect of Medium Molecule HES (130/0.4) in Complications for Patients After Abdominal Surgery
- ClinicalTrials.gov ID
- NCT00308126
- Acronym / sponsor ID
- BFP501
- Conditions
- Postoperative Complications
- Keywords
- Abdominal operation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 624 participants
- Lead sponsor
- Fresenius KabiIndustry (pharma, biotech, devices)
- Study start
- Jun 2005
- Study completion
- Sep 2006
- 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.
Purpose: To compare the incidence of post-surgery complications and evaluate relevant parameters within 28 days after an operation in HES (130/0.4) and albumin treated groups
Study Design: Open-label, active controlled, parallel group, randomized, multi-center study. Per protocol, 624 patients required in 6 study centers.
Hypothesis: No difference in rate of postoperative (post-op) complications between HES and albumin groups
Detailed description
Since the application of surgical operations, postoperative complications have been the area surgeons explored the most. Though surgical technological advances make it possible for most patients to recover from an operation, the prevention and management of the postoperative complications are still important for surgeons.
Traditionally, the level of albumin is an important marker for the prognosis of the patient. When the level of albumin is below 35 g/L, the mortality rate and other complications will increase significantly, so albumin has become the widely used colloid liquid in fluid therapy for postoperative patients. Actually, the body cannot utilize exogenous albumin and it takes 6-7 days for the body to synthesize new albumin. There is dispute concerning whether albumin should be used in postoperative treatments for severely ill patients. The well-known SAFE study found there was no difference in the efficacy between albumin and crystalloids for severe patients in the 28-day observation time. A meta analysis of 24 studies involving 1419 patients came to the conclusion that administration of albumin could increase the mortality rate in patients. The high price of albumin is another target for extensive criticism.
On the other hand, maintaining colloid osmotic pressure at a certain level in the circulatory system is essential for postoperative patients to stabilize hemodynamics, reduce tissue edema, improve recovery, so it is beneficial for patients to replace albumin with Voluven (130/0.4). Voluven (130/0.4) is a medium-molecular-weight hydroxyethyl starch produced by Fresenius Kabi Pharmaceutical Co. Ltd, and is widely used clinically in volume replacement therapy. Its efficacy and safety are proved by its clinical practices, however, its effect in patients with postoperative complications is not clear. The study will compare the effect of Voluven (130/0.4) and albumin on the occurrence of postoperative complications in patients with an abdominal operation to provide guidance on selection of safe and economic volume replacement therapy for postoperative patients.
STUDY OBJECTIVES
To compare the effect of Voluven (130/0.4) to that of albumin for occurrence of postoperative complications in patients with abdominal surgery from the day of the operation to 28th day after the operation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age from 18 to 75, male or female
- After abdominal operation of medium scale or above (including but not limited to: gastric cancer eradication, rectal cancer eradication, hepatic lobectomy, corpus and cauda pancreatectomy)
- Hemoglobin (Hb) no less than 70g/L; serum albumin no less than 30 g/L before operation
- Blood loss during operation no more than 2000 ml
Key exclusion criteria (9 listed)
- Known to be allergic to HES or albumin
- Urine output less than 500 ml/24 hours
- Intra-cranial hemorrhage
- Liver transplantation
- Use colloid other than study drugs
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 |
|---|---|---|
| Hydroxyethyl Starch 130/0.4 (Voluven) | Drug | – |
Primary outcome
Occurrence of any postoperative complication stipulated in protocol within 28 days after abdominal operation
1 secondary outcome
28th day after abdominal operation
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 11 Dec 2007.
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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.
Yupei Zhao principal investigator
Peking Union Medical College 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 Hydroxyethyl Starch 130/0.4 (Voluven) in people with Postoperative 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 4 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 11 Dec 2007. 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 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?
Occurrence of any postoperative complication stipulated in protocol within 28 days after abdominal operation. 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 11 Dec 2007.