RhabdomyolysisHicoRhabdoNCT01467180
Myoglobin Removal by High Cut-off CVVHD
A study testing septeX and HF CVVH in people with Rhabdomyolysis and Renal Failure, run by Vantive Health LLC at 1 site in Germany.
Trial summary
A high cut-off dialyzer (septeX) is tested for the removal of myoglobin which is not efficiently removed by standard high flux dialysis membranes. Hypothesis: The high cut-off dialyzer (septeX) can remove 2-fold more efficiently myoglobin from the circulation of Rhabdomyolysis patients as by conventional treatment… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rhabdomyolysis, Renal Failure
- What is being tested?
- septeX and HF CVVH
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2011to May 2014
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acute Rhabdomyolysis
- placed central venous catheter
- Indication for RRT due to Serum CK level > 5000 u/L
- Age ≥ 18 years
- Signed ICF
Who cannot join
- End stage CKD (dialysis dependent) renal failure before manifestation of rhabdomyolysis
- Pregnancy or lactation
- Palliative treatment
- Participation in other clinical studies
Trial locations and contacts
1 site in 1 country.
Germany1 site
Klinik für Anästhesiologie, Intensivmedizin, Uni-Klinikum
Frankfurt am Main, Hesse, 60590
About this study
Official title: Myoglobin Reduction by High Cut-off (HCO) Continuous Veno- Venous Hemodialysis (CVVHD) in Patients With Rhabdomyolysis and an Increased Risk for Acute Kidney Injury
A high cut-off dialyzer (septeX) is tested for the removal of myoglobin which is not efficiently removed by standard high flux dialysis membranes. Hypothesis: The high cut-off dialyzer (septeX) can remove 2-fold more efficiently myoglobin from the circulation of Rhabdomyolysis patients as by conventional treatment with standard high flux dialyzer.
Read the detailed description
Excess myoglobin in the circulation is a causative pathogenetic factor of rhabdomyolysis associated with acute kidney injury (AKI). The rapid elimination of myoglobin by standard dialysis membranes is limited to its molecular weight of 17.8kDa, although some removal can be achieved when a convective therapy is applied.
Significant clearance for myoglobin has been reported for high flux membranes from < 8 mL/min (5) up to 22 mL/h (CVVH) (10) and for high cut-off (HCO) membranes a mean clearance rate of 36.2 mL/min in HD mode (7) and 39.2 mL/h in CVVH mode (5). The use of high cut-off (HCO) continuous veno- venous hemodialysis (CVVHD) may constitute a novel therapeutic strategy for effectively reduction of myoglobin in the patient's serum to ameliorate the course of AKI.
Previously, a case study of the removal of myoglobin by HCO-CVVH in one single patient with severe rhabdomyolysis was published.
- Conditions
- Rhabdomyolysis, Renal Failure
- Being tested
- septeX, HF CVVH
- Keywords
- septeX, CVVH, CVHD, myoglobin
- Medical subject headings
- Rhabdomyolysis, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
septeXDevice
continuous veno-venose hemodialysis (CVVHD) with dialysate flow rate (Qd)of 35ml/kg/h for 48h
HF CVVHDevice
continuous veno-venose hemofiltration (CVVH) with 35ml/kg/h UF-rate for 48h
| Study group | Role | What they receive |
|---|---|---|
| HCO CVVHD | Experimental | treatment of rhabdomyolysis pts with septeX dialyzer Receives: Device: septeX |
| HF CVVH | Active comparator | treatment of rhabdomyolysis pts with standard high flux dialyzer Receives: Device: HF CVVH |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myoglobin plasma level
Two fold- increased reduction of myoglobin plasma level in favor of the HCO CVVHD group compared with standard therapy group (HF-CVVH and fluid therapy, respectively) after 48 hours treatment time.
Measured: 24h
Secondary outcomes (5)
eGFR
Estimation of kidney function by estimated glomerular filtration rate (eGFR)
Measured: at 3 and 6 month after treatment
Duration of hospital stay (days)and Duration of ICU stay (days)
Measured: 6 month
Duration of dialysis dependence (days)
Measured: 6 month
Diuresis / oliguria (<0.5 ml/kg/12h)/ anuria
Measured: 6 month
patient survival
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionApr 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RhabdomyolysisStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vantive Health LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Gambro Dialysatoren GmbH, Baxter Healthcare Corporation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01467180
- Sponsor's protocol ID
- 1490
- Other IDs
- CIV-11-06-000843
- Acronym
- HicoRhabdo
- Status last verified
- Mar 2025
- First submitted
- 4 Nov 2011
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Myoglobin Reduction by High Cut-off (HCO) Continuous Veno- Venous Hemodialysis (CVVHD) in Patients With Rhabdomyolysis and an Increased Risk for Acute Kidney Injury
- ClinicalTrials.gov ID
- NCT01467180
- Acronym / sponsor ID
- HicoRhabdo / 1490
- Conditions
- Rhabdomyolysis, Renal Failure
- Keywords
- septeX, CVVH, CVHD, myoglobin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Vantive Health LLCIndustry (pharma, biotech, devices)
- Collaborators
- Gambro Dialysatoren GmbH, Baxter Healthcare Corporation
- Study start
- Nov 2011
- Primary completion
- Apr 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 8 Nov 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.
A high cut-off dialyzer (septeX) is tested for the removal of myoglobin which is not efficiently removed by standard high flux dialysis membranes. Hypothesis: The high cut-off dialyzer (septeX) can remove 2-fold more efficiently myoglobin from the circulation of Rhabdomyolysis patients as by conventional treatment with standard high flux dialyzer.
Detailed description
Excess myoglobin in the circulation is a causative pathogenetic factor of rhabdomyolysis associated with acute kidney injury (AKI). The rapid elimination of myoglobin by standard dialysis membranes is limited to its molecular weight of 17.8kDa, although some removal can be achieved when a convective therapy is applied.
Significant clearance for myoglobin has been reported for high flux membranes from < 8 mL/min (5) up to 22 mL/h (CVVH) (10) and for high cut-off (HCO) membranes a mean clearance rate of 36.2 mL/min in HD mode (7) and 39.2 mL/h in CVVH mode (5). The use of high cut-off (HCO) continuous veno- venous hemodialysis (CVVHD) may constitute a novel therapeutic strategy for effectively reduction of myoglobin in the patient's serum to ameliorate the course of AKI.
Previously, a case study of the removal of myoglobin by HCO-CVVH in one single patient with severe rhabdomyolysis was published.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HCO CVVHD | Experimental | Device: septeXtreatment of rhabdomyolysis pts with septeX dialyzer |
| HF CVVH | Active comparator | Device: HF CVVHtreatment of rhabdomyolysis pts with standard high flux dialyzer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Acute Rhabdomyolysis
- placed central venous catheter
- Indication for RRT due to Serum CK level > 5000 u/L
- Age ≥ 18 years
- Signed ICF
Key exclusion criteria (4 listed)
- End stage CKD (dialysis dependent) renal failure before manifestation of rhabdomyolysis
- Pregnancy or lactation
- Palliative treatment
- Participation in other clinical studies
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 |
|---|---|---|
| septeXcontinuous veno-venose hemodialysis (CVVHD) with dialysate flow rate (Qd)of 35ml/kg/h for 48h | Device | HCO CVVHD |
| HF CVVHcontinuous veno-venose hemofiltration (CVVH) with 35ml/kg/h UF-rate for 48h | Device | HF CVVH |
Primary outcome
Myoglobin plasma level
Time frame: 24h
Two fold- increased reduction of myoglobin plasma level in favor of the HCO CVVHD group compared with standard therapy group (HF-CVVH and fluid therapy, respectively) after 48 hours treatment time.
5 secondary outcomes
eGFR
Time frame: at 3 and 6 month after treatment
Duration of hospital stay (days)and Duration of ICU stay (days)
Time frame: 6 month
Duration of dialysis dependence (days)
Time frame: 6 month
Diuresis / oliguria (<0.5 ml/kg/12h)/ anuria
Time frame: 6 month
patient survival
Time frame: 6 month
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 13 Mar 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing septeX and HF CVVH in people with Rhabdomyolysis and Renal Failure, run by Vantive Health LLC at 1 site 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 5 inclusion and 4 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 13 Mar 2025. 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 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.
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?
Myoglobin plasma level (time frame: 24h). 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 13 Mar 2025.