Decreased and Nonspecific Blood Pressure Disorders and ShockPhase 3NCT01301469
Comparison of HES 130 in Balanced and in Unbalanced Solution
A Phase 3 study testing 6% HES 130/0.42 in plasma adapted Ringer's solution and 6% HES 130/0.4 in a saline solution in people with Decreased and Nonspecific Blood Pressure Disorders and Shock, run by B. Braun Melsungen AG at 4 sites in China.
Trial summary
The purpose of this study is to evaluate the efficacy of HES 130/0.42 in an electrolyte infusion in comparison to HES 130/0.4 in a sodium chloride infusion. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Decreased and Nonspecific Blood Pressure Disorders and Shock
- What is being tested?
- 6% HES 130/0.42 in plasma adapted Ringer's solution and 6% HES 130/0.4 in a saline solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 4 sitesChina
- Study dates
- Feb 2011to Jul 2011
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female (non pregnant) patients; between 18 and 70 years
- Elective non-cardiac surgery (except pancreatic or neurological surgery) with an estimated operation duration of 2 hours or longer
- General anesthesia
- Voluntary consent
Who cannot join
- Patients of ASA-class III or IV, Cardiac insufficiency NYHA classes III. IV
- BMI < 18 or > 29
- Patients with daily urine output < 1L
- Patients on hemodialysis
- Abnormal liver or renal function (i. e. above upper limit of normal range)
- Abnormal coagulation function (prothrombin time (PT) 3 seconds higher than normal or activated partial thromboplastin time (APTT) 10 seconds higher than normal)
Show all 12Show fewer
- Hgb < 10g/dl or HCT < 30%
- Potassium, sodium or chloride above the upper limit of normal of the laboratory
- History of diabetes mellitus
- Known history of a mental or neurological disorder, such as epileptic seizures.
- History of hypertension and/or taking a beta-receptor blocker or history of atrial fibrillation
- Patients with known hypersensitivity and with contraindications to HES or any of the excipients
Trial locations and contacts
4 sites in 1 country.
China4 sites
2 Hospitals
Beijing
Hospital
Guangzhou
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, 200025
Hospital
Shanghai
About this study
Official title: Prospective, Randomized, Double-blind, Controlled, Multicenter Study on the Efficacy and Safety of HES 130/0. 42 in a Balanced Electrolyte Solution vs a HES 130/0.4 in a Sodium Chloride Solution in Elective Surgery Patients
The purpose of this study is to evaluate the efficacy of HES 130/0.42 in an electrolyte infusion in comparison to HES 130/0.4 in a sodium chloride infusion.
- Being tested
- 6% HES 130/0.42 in plasma adapted Ringer's solution, 6% HES 130/0.4 in a saline solution
- Medical subject headings
- Shock
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
6% HES 130/0.42 in plasma adapted Ringer's solutionDrug
60 g/l hydroxyethyl starch 130 dissolved in plasma adapted Ringer's solution (balanced solution)
6% HES 130/0.4 in a saline solutionDrug
60 g/l Hydroxyethyl starch (HES) with a mean molecular weight of 130 kDalton which is dissolved in a saline solution
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 6% HES 130/0.42 in plasma adapted Ringer's solution (balanced solution) Receives: Drug: 6% HES 130/0.42 in plasma adapted Ringer's solution |
| 2 | Active comparator | HES 130/0.4 in a saline solution Receives: Drug: 6% HES 130/0.4 in a saline solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum difference of the mean arterial blood pressure
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2011 (estimated)
- Study startFeb 2011
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Decreased and Nonspecific Blood Pressure Disorders and ShockStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- B. Braun Melsungen AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Buwei Yu, Prof. Dr., Principal investigator, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01301469
- Sponsor's protocol ID
- HC-G-H-0801
- Status last verified
- Jan 2012
- First submitted
- 11 Feb 2011
- Last updated
- 5 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized, Double-blind, Controlled, Multicenter Study on the Efficacy and Safety of HES 130/0. 42 in a Balanced Electrolyte Solution vs a HES 130/0.4 in a Sodium Chloride Solution in Elective Surgery Patients
- ClinicalTrials.gov ID
- NCT01301469
- Acronym / sponsor ID
- HC-G-H-0801
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- B. Braun Melsungen AGIndustry (pharma, biotech, devices)
- Study start
- Feb 2011
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 23 Feb 2011 (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 evaluate the efficacy of HES 130/0.42 in an electrolyte infusion in comparison to HES 130/0.4 in a sodium chloride infusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: 6% HES 130/0.42 in plasma adapted Ringer's solution6% HES 130/0.42 in plasma adapted Ringer's solution (balanced solution) |
| 2 | Active comparator | Drug: 6% HES 130/0.4 in a saline solutionHES 130/0.4 in a saline solution |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female (non pregnant) patients; between 18 and 70 years
- Elective non-cardiac surgery (except pancreatic or neurological surgery) with an estimated operation duration of 2 hours or longer
- General anesthesia
- Voluntary consent
Key exclusion criteria (12 listed)
- Patients of ASA-class III or IV, Cardiac insufficiency NYHA classes III. IV
- BMI < 18 or > 29
- Patients with daily urine output < 1L
- Patients on hemodialysis
- Abnormal liver or renal function (i. e. above upper limit of normal range)
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 130/0.42 in plasma adapted Ringer's solution60 g/l hydroxyethyl starch 130 dissolved in plasma adapted Ringer's solution (balanced solution) | Drug | 1 |
| 6% HES 130/0.4 in a saline solution60 g/l Hydroxyethyl starch (HES) with a mean molecular weight of 130 kDalton which is dissolved in a saline solution | Drug | 2 |
Primary outcome
Maximum difference of the mean arterial blood pressure
Time frame: 1 hour
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 Jan 2012.
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.
Buwei Yu, Prof. Dr. principal investigator
Ruijin Hospital
4 sites 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% HES 130/0.42 in plasma adapted Ringer's solution and 6% HES 130/0.4 in a saline solution in people with Decreased and Nonspecific Blood Pressure Disorders and Shock, run by B. Braun Melsungen AG at 4 sites 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 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 5 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 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?
Maximum difference of the mean arterial blood pressure (time frame: 1 hour). 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 Jan 2012.