PancreaticoduodenectomyPhase 3NCT01758172
Comparison of Hemodynamic Effects of Two Colloid Therapies in Post-operative Patients Undergoing Pancreaticoduodenectomy
A Phase 3 study testing 6% hydroxyethyl starch 130/0.4 and Albumin in people with Pancreaticoduodenectomy, run by Asan Medical Center at 1 site in South Korea.
Trial summary
From postoperative patients having undergone pancreaticoduodenectomy; 1. To compare the hemodynamic parameters from the patient administrated 5% HA and 6% Voluven 2. To assess the efficacy of the treatment as regards the clinical outcomes and laboratory parameters of the patient 3. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pancreaticoduodenectomy
- What is being tested?
- 6% hydroxyethyl starch 130/0.4 and Albumin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2009to Jan 2012
- Phase
- Phase 3
- 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
- Subjects should be meet inclusion criteria to participated into the study
- Age-from 18-75 years adult
- In the immediate post-operative period of pancreaticoduodenectomy
- Written informed consent and admitted ICU immediate post-operative patient
Who cannot join
- Any patient meeting one or more of the following exclusion criteria may not be entered into the study.
- Refusal to participate in the study
- Evidence of pre-operative oliguria (Serum creatinine>1.5mmol/dL)
- Known Severe congestive heart failure (NYHAIII,IV)
- Known severe respiratory diseases (PaO2/FiO2 <200)
- Known coagulopathy (Platelet<100k/mm3, aPTT>70s, PT(INR)>2.5)
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- Known allergy to hydroxyethyl starch
- Known pregnancy or lactation
- Has participated in any other clinical trial within 3months
- Any contraindication to Voluven® or albumin according to their package inserts.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Hemodynamic and Clinical Effects of Two Colloid Therapies in Post-operative Patients Undergoing Pancreaticoduodenectomy
From postoperative patients having undergone pancreaticoduodenectomy;
- To compare the hemodynamic parameters from the patient administrated 5% HA and 6% Voluven
- To assess the efficacy of the treatment as regards the clinical outcomes and laboratory parameters of the patient
- To compare the safety of the 2 intravenous colloids in the patient population
- Conditions
- Pancreaticoduodenectomy
- Being tested
- 6% hydroxyethyl starch 130/0.4, Albumin
- Keywords
- pancreaticoduodenectomy, postoperative patient, colloid, albumin, hetastarch
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
6% hydroxyethyl starch 130/0.4Drug
AlbuminDrug
| Study group | Role | What they receive |
|---|---|---|
| Albumin | Active comparator | albumin was administered to reach CVP up to 7mmHg Receives: Drug: Albumin |
| 6% hydroxyethyl starch 130/0.4 | Experimental | 6% hydroxyethyl starch 130/0.4 was administered to reach CVP up to 7mmHg Receives: Drug: 6% hydroxyethyl starch 130/0.4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean arterial pressure
Measured: post-op 24hr
Secondary outcomes (1)
Volume(ml) of colloid
Measured: post-op 24hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2013 (estimated)
- Study startOct 2009
- Primary completionOct 2010
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PancreaticoduodenectomyStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe 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 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Song Cheol Kim, Asan Medical Center
- Investigators
- Song-cheol Kim, MD., PhD., Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01758172
- Sponsor's protocol ID
- 2008-1001
- Status last verified
- Jan 2013
- First submitted
- 16 Nov 2012
- Last updated
- 3 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Hemodynamic and Clinical Effects of Two Colloid Therapies in Post-operative Patients Undergoing Pancreaticoduodenectomy
- ClinicalTrials.gov ID
- NCT01758172
- Acronym / sponsor ID
- 2008-1001
- Conditions
- Pancreaticoduodenectomy
- Keywords
- pancreaticoduodenectomy, postoperative patient, colloid, albumin, hetastarch
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Oct 2010 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 1 Jan 2013 (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.
From postoperative patients having undergone pancreaticoduodenectomy;
- To compare the hemodynamic parameters from the patient administrated 5% HA and 6% Voluven
- To assess the efficacy of the treatment as regards the clinical outcomes and laboratory parameters of the patient
- To compare the safety of the 2 intravenous colloids in the patient population
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Albumin | Active comparator | Drug: Albuminalbumin was administered to reach CVP up to 7mmHg |
| 6% hydroxyethyl starch 130/0.4 | Experimental | Drug: 6% hydroxyethyl starch 130/0.46% hydroxyethyl starch 130/0.4 was administered to reach CVP up to 7mmHg |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects should be meet inclusion criteria to participated into the study
Key exclusion criteria (10 listed)
- Any patient meeting one or more of the following exclusion criteria may not be entered into the study.
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% hydroxyethyl starch 130/0.4 | Drug | 6% hydroxyethyl starch 130/0.4 |
| Albumin | Drug | Albumin |
Primary outcome
Mean arterial pressure
Time frame: post-op 24hr
1 secondary outcome
Volume(ml) of colloid
Time frame: post-op 24hrs
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 3 Jan 2013.
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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.
Song-cheol Kim, MD., PhD. principal investigator
Asan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 6% hydroxyethyl starch 130/0.4 and Albumin in people with Pancreaticoduodenectomy, run by Asan Medical Center 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 4 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: finished, as of the sponsor's last update on 3 Jan 2013. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Mean arterial pressure (time frame: post-op 24hr). 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 3 Jan 2013.