WithdrawnNot Applicable

High Cut Off Dialysis in Systemic Inflammatory Response Syndrome Patients After Cardiac Surgery

Stopped: Study halted prematurely, prior to enrollment of first patient, due to recruiting problems.

Germany0Started 2012-04

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

IL6/IL10 ratio

Timeframe: 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)

Trial details

NCT IDNCT01579396

SponsorVantive Health LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2013-09

View on ClinicalTrials.gov More Systemic Inflammatory Response Syndrome trials