Renal InsufficiencyPhase 4NCT00936247
Tetraspan 6 Percent (%) Combined With Sterofundin ISO Versus Albumin 5 Percent (%) Combined With Sodium Chloride (NaCL)
A Phase 4 study testing HES 130/0.42 + electrolyte solution and Albumin + electrolyte solution in people with Renal Insufficiency, run by B. Braun Melsungen AG at 2 sites in Germany.
Trial summary
This investigational study will investigate two different volume replacement regimes in patients suffering from compromised renal function. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Renal Insufficiency
- What is being tested?
- HES 130/0.42 + electrolyte solution and Albumin + electrolyte solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 2 sitesGermany
- Study dates
- Nov 2009to Sep 2010
- 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- male or female patients
- ≥ 50 years of age;
- patients with compromised renal function, i.e. serum creatinine between 1.5 mg/dl and 3.0 mg/dl;
- patients scheduled for elective intervention;
- patients with an estimated intraoperative volume need of at least 1 l colloids;
- provision of voluntary informed 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 ASA-class > III;
- patients with daily urine output < 1 l;
- patients on haemodialysis;
- patients receiving HES during the last 48 hours before first infusion of the investigational products;
- patients suffering from coagulation disorders (i.e. PTT > 60 sec);
- patients with a hemoglobin < 9 g/dl;
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- patients with known hypersensitivity to HES, albumin or any of the excipients;
- patients suffering from contraindications of the investigational products (i.e. hyperhydration state including pulmonary oedema, renal failure with oliguria or anuria, intracranial haemorrhage, hyperkalaemia, severe hypernatraemia or severe hyperchloraemia, severely impaired hepatic function, congestive heart failure);
- simultaneous participation in another clinical trial; emergencies;
- patients scheduled for brain surgery;
- patients incapable to give informed consent (e.g. patients with dementia, psychiatric diseases or suffering from conditions associated with lack of consciousness)
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Klinik für Anästhesiologie und operative Intensivmedizin, Klinikum der Stadt Ludwigshafen
Ludwigshafen, 67064
Klinikum Mannheim gGmbH, Klinik für Anästhesiologie und Operative Intensivmedizin
Mannheim, 68167
About this study
Official title: Prospective, Controlled, Single-blind, Bicentric, Randomized Study on the Safety of HES 130/0.42 Combined With a Bal. Electr. Sol. vs 5% Albumin Comb. With an Unbal. Electr. Sol. (NaCl 0.9%) in Pat. With Compensated Renal Failure
This investigational study will investigate two different volume replacement regimes in patients suffering from compromised renal function.
- Conditions
- Renal Insufficiency
- Being tested
- HES 130/0.42 + electrolyte solution, Albumin + electrolyte solution
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HES 130/0.42 + electrolyte solutionDrug
Tetraspan 6% as colloid component combined with Sterofundin ISO as electrolyte component
Albumin + electrolyte solutionDrug
Albumin 5% as colloid component and NaCl 0.9% as electrolyte component
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | HES 130/0.42 + Sterofundin ISO Receives: Drug: HES 130/0.42 + electrolyte solution |
| 2 | Active comparator | Albumin + NaCl 0.9% Receives: Drug: Albumin + electrolyte solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of two different volume replacement regimes on base excess in patients with reduced renal function
Measured: from pre-operative assessment until last evaluation of data i.e. 5th (hospital) and 60th postoperative day (follow-up)
Secondary outcomes (1)
Renal function, hemodynamics, blood loss, amount of given blood products, electrolytes, outcome and other data like concomitant medication
Measured: inta-/postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2009 (estimated)
- Study startNov 2009
- Primary completionSep 2010 (estimated)
- Study completionSep 2010 (estimated)
Why it stopped: organizational reasons at sites: low recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal InsufficiencyStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- B. Braun Melsungen AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Thomas Lücke, Prof. Dr., Principal investigator, Klinikum Mannheim gGmbH, Klink für Anästhesiologie und Operative Intensivmedizin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00936247
- Sponsor's protocol ID
- HC-G-H-0514
- Status last verified
- Sep 2010
- First submitted
- 8 Jul 2009
- Last updated
- 28 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Controlled, Single-blind, Bicentric, Randomized Study on the Safety of HES 130/0.42 Combined With a Bal. Electr. Sol. vs 5% Albumin Comb. With an Unbal. Electr. Sol. (NaCl 0.9%) in Pat. With Compensated Renal Failure
- ClinicalTrials.gov ID
- NCT00936247
- Acronym / sponsor ID
- HC-G-H-0514
- Conditions
- Renal Insufficiency
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: organizational reasons at sites: low recruitment
- Enrolment
- 2 participants (actual)
- Lead sponsor
- B. Braun Melsungen AGIndustry (pharma, biotech, devices)
- Study start
- Nov 2009
- Primary completion
- Sep 2010 (estimated)
- Study completion
- Sep 2010 (estimated)
- First posted
- 9 Jul 2009 (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.
This investigational study will investigate two different volume replacement regimes in patients suffering from compromised renal function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: HES 130/0.42 + electrolyte solutionHES 130/0.42 + Sterofundin ISO |
| 2 | Active comparator | Drug: Albumin + electrolyte solutionAlbumin + NaCl 0.9% |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- male or female patients
- ≥ 50 years of age;
- patients with compromised renal function, i.e. serum creatinine between 1.5 mg/dl and 3.0 mg/dl;
- patients scheduled for elective intervention;
- patients with an estimated intraoperative volume need of at least 1 l colloids;
Key exclusion criteria (11 listed)
- patients of ASA-class > III;
- patients with daily urine output < 1 l;
- patients on haemodialysis;
- patients receiving HES during the last 48 hours before first infusion of the investigational products;
- patients suffering from coagulation disorders (i.e. PTT > 60 sec);
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 130/0.42 + electrolyte solutionTetraspan 6% as colloid component combined with Sterofundin ISO as electrolyte component | Drug | 1 |
| Albumin + electrolyte solutionAlbumin 5% as colloid component and NaCl 0.9% as electrolyte component | Drug | 2 |
Primary outcome
Impact of two different volume replacement regimes on base excess in patients with reduced renal function
Time frame: from pre-operative assessment until last evaluation of data i.e. 5th (hospital) and 60th postoperative day (follow-up)
1 secondary outcome
Renal function, hemodynamics, blood loss, amount of given blood products, electrolytes, outcome and other data like concomitant medication
Time frame: inta-/postoperative
Results and safety
The study was stopped early (reason given: organizational reasons at sites: low recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2010.
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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.
Thomas Lücke, Prof. Dr. principal investigator
Klinikum Mannheim gGmbH, Klink für Anästhesiologie und Operative Intensivmedizin
2 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 130/0.42 + electrolyte solution and Albumin + electrolyte solution in people with Renal Insufficiency, run by B. Braun Melsungen AG at 2 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 6 inclusion and 11 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 28 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 was stopped early (reason given: organizational reasons at sites: low recruitment). 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?
Impact of two different volume replacement regimes on base excess in patients with reduced renal function (time frame: from pre-operative assessment until last evaluation of data i.e. 5th (hospital) and 60th postoperative day (follow-up)). 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 28 Sep 2010.