NCT01467180

Brief 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 with standard high flux dialyzer.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

November 4, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 8, 2011

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

March 13, 2025

Status Verified

March 1, 2025

Enrollment Period

2.4 years

First QC Date

November 4, 2011

Last Update Submit

March 11, 2025

Conditions

RhabdomyolysisRenal Failure

Keywords

septeXCVVHCVHDmyoglobin

Outcome Measures

Primary Outcomes (1)

  • 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.

    24h

Secondary Outcomes (5)

  • eGFR

    at 3 and 6 month after treatment

  • Duration of hospital stay (days)and Duration of ICU stay (days)

    6 month

  • Duration of dialysis dependence (days)

    6 month

  • Diuresis / oliguria (<0.5 ml/kg/12h)/ anuria

    6 month

  • patient survival

    6 month

Study Arms (2)

HCO CVVHD

EXPERIMENTAL

treatment of rhabdomyolysis pts with septeX dialyzer

Device: septeX

HF CVVH

ACTIVE COMPARATOR

treatment of rhabdomyolysis pts with standard high flux dialyzer

Device: HF CVVH

Interventions

septeXDEVICE

continuous veno-venose hemodialysis (CVVHD) with dialysate flow rate (Qd)of 35ml/kg/h for 48h

HCO CVVHD
HF CVVHDEVICE

continuous veno-venose hemofiltration (CVVH) with 35ml/kg/h UF-rate for 48h

HF CVVH

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Acute Rhabdomyolysis
  • placed central venous catheter
  • Indication for RRT due to Serum CK level \> 5000 u/L
  • Age ≥ 18 years
  • Signed ICF

You may not qualify if:

  • End stage CKD (dialysis dependent) renal failure before manifestation of rhabdomyolysis
  • Pregnancy or lactation
  • Palliative treatment
  • Participation in other clinical studies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinik für Anästhesiologie, Intensivmedizin, Uni-Klinikum

Frankfurt am Main, Hesse, 60590, Germany

Location

MeSH Terms

Conditions

RhabdomyolysisRenal Insufficiency

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 4, 2011

First Posted

November 8, 2011

Study Start

November 1, 2011

Primary Completion

April 1, 2014

Study Completion

May 1, 2014

Last Updated

March 13, 2025

Record last verified: 2025-03

Locations

DE(1)