NCT01579396

Brief Summary

A high cut off dialyzer (septeX) is tested in patients after cardio-thoracic surgery with incidence of "systemic inflammatory response syndrome" (SIRS) and associated increased risk for acute kidney injury (AKI). Hypothesis: The high cut off dialyzer (septeX) can increase the postoperative IL-6/Il-10 ratio.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2012

Geographic Reach
1 country

1 active site

Status
withdrawn

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

First Submitted

Initial submission to the registry

January 18, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2012

Completed
17 days until next milestone

First Posted

Study publicly available on registry

April 18, 2012

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

March 13, 2025

Status Verified

March 1, 2025

Enrollment Period

1.4 years

First QC Date

January 18, 2012

Last Update Submit

March 11, 2025

Conditions

Systemic Inflammatory Response SyndromeAcute Kidney Injury

Keywords

septeXhigh cut-offThoracic SurgeryRenal Replacement Therapy

Outcome Measures

Primary Outcomes (1)

  • IL6/IL10 ratio

    To test, if immediate postoperative HCO-CVVH reduces systemic inflammation (determined as the ratio between Il-6 / Il-10) in patients with a high risk for CSA-AKI in comparison with a treatment without early RRT. To calibrate for differences in baseline cytokine levels and with respect to the high variability of cytokines in the postoperative period the area-under-the-curve (AUC) of the postoperative increase in the IL-6/Il-10 ratio until 48h will be used.

    Change from Baseline in IL6/IL10 ratio at 48h post cardiac surgery and last day at hospital (expected average of 2 weeks after cardiac surgery)

Secondary Outcomes (3)

  • determination of immediate postoperative HCO-CVVH improvement

    6 month post cardiac surgery

  • Laboratory assessments

    48h after cardiac surgery and last day at hospital (expected average 2 weeks)

  • adverse effects

    48h after cardiac surgery

Study Arms (2)

septeX

EXPERIMENTAL

septeX CVVH for 12h after cardiac surgery

Device: septeX

standard therapy

OTHER

standard therapy according to local practice

Other: standard therapy

Interventions

septeXDEVICE

12 h septeX CVVH treatment after cardiac surgery

Also known as: high cut off
septeX
standard therapyOTHER

standard therapy either pharmacological and /or continuous renal replacement therapy (CRRT)

standard therapy

Eligibility Criteria

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

You may qualify if:

  • Age ≥ 18 years
  • Scheduled for complex / prolonged cardiac surgery (i.e.combined CABG+ valve surgery, Redo surgery) with an anticipated CPB time \> 120 min
  • CKD with an e GFR \< 50ml/min/m2
  • Euroscore \> 6

You may not qualify if:

  • End stage CKD (dialysis dependent) renal failure before surgery
  • Radiocontrast exposure within 24 hours before surgery
  • Active endocarditic with antibiotic treatment
  • pulmonary disease with chronic hypoxia
  • Clinically significant liver dysfunction (bilirubin \> 1.8mg/dl (30µmol/L))
  • Known HIV, HCV infection
  • Alcoholism
  • Active uncontrolled infection
  • Pregnancy or lactation
  • Inability to give informed consent to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinik für Anaesthesiologie UKSH Luebeck

Lübeck, Schleswig-Holstein, 23538, Germany

Location

MeSH Terms

Conditions

Systemic Inflammatory Response SyndromeAcute Kidney Injury

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

InflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShockRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Matthias Heringlake, Prof. Dr.

    Universitaet zu Luebeck

    PRINCIPAL INVESTIGATOR
0

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

January 18, 2012

First Posted

April 18, 2012

Study Start

April 1, 2012

Primary Completion

September 1, 2013

Study Completion

December 1, 2013

Last Updated

March 13, 2025

Record last verified: 2025-03

Locations

DE(1)