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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2013-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

High Cut-Off Continuous Veno-venous Hemodialysis (CVVHD) in Patients Treated for Acute Renal Failure After Systemic Inflammatory Response Syndrome (SIRS)/Septic Shock

NCT00875888

Systemic Inflammatory Response Syndrome Kidney Failure, Acute

TERMINATED NA

Continuous Renal Replacement Therapy With Oxiris in Acute Kidney Injury and Sepsis

NCT06253377

Acute Kidney Injury Sepsis

ACTIVE_NOT_RECRUITING

The Membrane Adsorbing OXiris Filter in Septic Patients With AKI

NCT03914586

Sepsis Acute Renal Failure

UNKNOWN

Antibiotic Plasma Concentrations During Continuous Renal Replacement Therapy With a High Adsorption Membrane (oXiris®)

NCT04033029

Hemodiafiltration Sepsis Acute Kidney Injury

COMPLETED

Increased Adsorption Membranes During Cardiopulmonary Bypass

NCT02518087

Cardiopulmonary Bypass Cardiac Surgery Associated - Acute Kidney Injury Systemic Inflammatory Response Syndrome +1 more

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Cardiac surgery associated systemic inflammatory response syndrome (SIRS) plays an important pathophysiological role in the development of AKI in patients after cardiothoracic surgery.

Previous studies have shown that the elimination of inflammatory mediators can be either achieved by Continuous Venous Venous Hemodialysis(CVVHD) or Continuous Venous Venous Hemofiltration (CVVH) by using a high-cutoff (HCO) membrane with a cut-off 45kD. Data from patients treated with HCO-CVVHD during septic shock show a reduction in systemic cytokines and improved hemodynamics.

No data about the effects of early HCO-CVVH in cardiac surgery patients with a high risk of Cardiac Surgery associated AKI and consequently a high rate of postoperative renal replacement therapy (RRT) are available.

It is of note that patients with Euroscore \> 6 are on high risk to develop SIRS associated AKI.

No pharmacological anti-inflammatory approach has convincingly shown to prevent renal dysfunction in these patients.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Systemic Inflammatory Response Syndrome Acute Kidney Injury

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

septeX

septeX CVVH for 12h after cardiac surgery

Group Type EXPERIMENTAL

septeX

Intervention Type DEVICE

12 h septeX CVVH treatment after cardiac surgery

standard therapy

standard therapy according to local practice

Group Type OTHER

standard therapy

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

septeX

12 h septeX CVVH treatment after cardiac surgery

Intervention Type DEVICE

standard therapy

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

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

high cut off

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No