Plasma Volume ReplacementPhase 4NCT01117649
Plasma Volume Replacement (PVR) Therapy With Colloid and Crystalloid Solutions
A Phase 4 study testing HES 10%, HES 6% and balanced electrolyte solution in people with Plasma Volume Replacement and Surgery of the Pancreatic Head, run by B. Braun Melsungen AG at 3 sites in Germany.
Trial summary
The purpose of this study is to investigate the efficacy of target controlled fluid therapy with a hyper-oncotic balanced HES solution compared to an iso-oncotic HES solution in patients undergoing elective surgery of the pancreatic head. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Plasma Volume Replacement, Surgery of the Pancreatic Head
- What is being tested?
- HES 10%, HES 6% and balanced electrolyte solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 3 sitesGermany
- Study dates
- May 2010to Jul 2013
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients scheduled to undergo elective surgery of the pancreatic head
- patients who are willing to give of voluntary consent to participate in the study, following a full explanation of the nature and purpose of the study, by signing the informed consent form approved by the Institutional Ethics Committee (IEC) prior to all evaluations.
Who cannot join
- patients of American Society of Anesthesiologists (ASA) class > III
- heart failure defined as New York Heart Association (NYHA) class>2
- aneurysm of the ascending and thoracic aorta
- patients with Zenker's diverticle
- local oesophageal disease (oesophageal stricture, oesophageal varices, previous oesophageal surgery in past 6 months before study inclusion, pharyngeal pouch)
- patients receiving haemodialysis
Show all 12Show fewer
- patients with known bleeding diatheses
- any bleeding disorder known from patient's history
- patients with a haematocrit <= 25% despite pre-operative transfusion
- renal insufficiency (serum creatinine > 130 µmol/l or >1.5 mg/dl) or oliguria or anuria
- impaired hepatic function defined as Mayo End-Stage Liver Disease (MELD) > 10 or liver cirrhosis Child-Pugh B or C
- additional contra-indications for investigational products
Trial locations and contacts
3 sites in 1 country.
Germany3 sites
Klinik für Anästhesie und operative Intensivmedizin, Charité-Universitätsmedizin Berlin
Berlin, 13353
Klinik für Anästhesie, operative Intensivmedizin und Schmerztherapie, Humboldt Klinikum
Berlin, 13509
Universitätsklinikum Bonn
Bonn, 53127
About this study
Official title: Prospective, Controlled, Double-blind, Randomized Multi-centric Study on the Efficacy and Safety of a Target Controlled PVR Therapy With a Hyperoncotic Balanced Hydroxyethyl Starch (HES) Solution Versus an Isooncotic Balanced HES Solution Compared to a Balanced Electrolyte Solution in Elective Surgery
The purpose of this study is to investigate the efficacy of target controlled fluid therapy with a hyper-oncotic balanced HES solution compared to an iso-oncotic HES solution in patients undergoing elective surgery of the pancreatic head. A third group receiving a balanced electrolyte solution (without colloidal volume replacement) will serve as a control for descriptive analysis.
- Being tested
- HES 10%, HES 6%, balanced electrolyte solution
- Keywords
- PVR, HES 130, pancreatic head, goal-directed, intraoperative PVR in elective surgery of the pancreatic head
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HES 10%Drug
HES 10% dissolved in plasma adapted Ringer's solution (balanced solution).
HES 6%Drug
HES 6% dissolved in plasma adapted Ringer's solution (balanced solution)
balanced electrolyte solutionDrug
plasma adapted Ringer's solution
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | hyper-oncotic colloid Receives: Drug: HES 10% |
| 2 | Active comparator | iso-oncotic colloid Receives: Drug: HES 6% |
| 3 | Active comparator | crystalloid Receives: Drug: balanced electrolyte solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
First endpoint: Intraoperatively required amount of HES (10%, 6%) (ml)
Goal-directed (stroke volume) plasma volume therapy
Measured: up to 8 hours
Second endpoint: Time until fully on oral (solid) diet (days)
Measured: up to 15 days
Secondary outcomes (1)
haemodynamics, arterial blood gas analysis, laboratory data, postoperative nausea and vomiting, adverse events, nursing delirium screening scale, several injury scores
Measured: up to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2010 (estimated)
- Study startMay 2010
- Primary completionJul 2012
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Plasma Volume ReplacementStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- B. Braun Melsungen AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Claudia Spies, Prof. Dr., Principal investigator, Klinik für Anästhesie und operative Intensivmedizin, Charité-Universitätsmedizin Berlin, Campus Virchow-Klinikum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01117649
- Sponsor's protocol ID
- HC-G-H-0803
- Status last verified
- Dec 2016
- First submitted
- 28 Apr 2010
- Last updated
- 23 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Eckers A, Hunsicker O, Spies C, Balzer F, Rubarth K, von Heymann C. In vivo effects of balanced, low molecular 6% and 10% hydroxyethyl starch compared with crystalloid volume replacement on the coagulation system in major pancreatic surgery-a sub-analysis of a prospective double-blinded, randomized controlled trial. PLoS One. 2024 Jul 11;19(7):e0303165. doi: 10.1371/journal.pone.0303165. eCollection 2024.
PubMed 38991044
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Controlled, Double-blind, Randomized Multi-centric Study on the Efficacy and Safety of a Target Controlled PVR Therapy With a Hyperoncotic Balanced Hydroxyethyl Starch (HES) Solution Versus an Isooncotic Balanced HES Solution Compared to a Balanced Electrolyte Solution in Elective Surgery
- ClinicalTrials.gov ID
- NCT01117649
- Acronym / sponsor ID
- HC-G-H-0803
- Keywords
- PVR, HES 130, pancreatic head, goal-directed, intraoperative PVR in elective surgery of the pancreatic head
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- B. Braun Melsungen AGIndustry (pharma, biotech, devices)
- Study start
- May 2010
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 5 May 2010 (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.
The purpose of this study is to investigate the efficacy of target controlled fluid therapy with a hyper-oncotic balanced HES solution compared to an iso-oncotic HES solution in patients undergoing elective surgery of the pancreatic head. A third group receiving a balanced electrolyte solution (without colloidal volume replacement) will serve as a control for descriptive analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: HES 10%hyper-oncotic colloid |
| 2 | Active comparator | Drug: HES 6%iso-oncotic colloid |
| 3 | Active comparator | Drug: balanced electrolyte solutioncrystalloid |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients scheduled to undergo elective surgery of the pancreatic head
- patients who are willing to give of voluntary consent to participate in the study, following a full explanation of the nature and purpose of the study, by signing the informed consent form approved by the Institutional Ethics Committee (IEC) prior to all evaluations.
Key exclusion criteria (12 listed)
- patients of American Society of Anesthesiologists (ASA) class > III
- heart failure defined as New York Heart Association (NYHA) class>2
- aneurysm of the ascending and thoracic aorta
- patients with Zenker's diverticle
- local oesophageal disease (oesophageal stricture, oesophageal varices, previous oesophageal surgery in past 6 months before study inclusion, pharyngeal pouch)
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 |
|---|---|---|
| HES 10%HES 10% dissolved in plasma adapted Ringer's solution (balanced solution). | Drug | 1 |
| HES 6%HES 6% dissolved in plasma adapted Ringer's solution (balanced solution) | Drug | 2 |
| balanced electrolyte solutionplasma adapted Ringer's solution | Drug | 3 |
Primary outcome
First endpoint: Intraoperatively required amount of HES (10%, 6%) (ml)
Time frame: up to 8 hours
Goal-directed (stroke volume) plasma volume therapy
Second endpoint: Time until fully on oral (solid) diet (days)
Time frame: up to 15 days
1 secondary outcome
haemodynamics, arterial blood gas analysis, laboratory data, postoperative nausea and vomiting, adverse events, nursing delirium screening scale, several injury scores
Time frame: up to 7 days
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 23 Dec 2016.
- Derived from this study: PubMed 38991044Eckers A, Hunsicker O, Spies C, Balzer F, Rubarth K, von Heymann C. In vivo effects of balanced, low molecular 6% and 10% hydroxyethyl starch compared with crystalloid volume replacement on the coagulation system in major pancreatic surgery-a sub-analysis of a prospective double-blinded, randomized controlled trial. PLoS One. 2024 Jul 11;19(7):e0303165. doi: 10.1371/journal.pone.0303165. eCollection 2024.
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.
Claudia Spies, Prof. Dr. principal investigator
Klinik für Anästhesie und operative Intensivmedizin, Charité-Universitätsmedizin Berlin, Campus Virchow-Klinikum
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing HES 10%, HES 6% and balanced electrolyte solution in people with Plasma Volume Replacement and Surgery of the Pancreatic Head, run by B. Braun Melsungen AG at 3 sites in Germany.
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 12 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 23 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany. 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?
First endpoint: Intraoperatively required amount of HES (10%, 6%) (ml) (time frame: up to 8 hours). 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?
On the ClinicalTrials.gov record for NCT01117649, which also lists 1 linked publication.
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 23 Dec 2016.