Last reviewed · How we verify
NCT04157647: IMHeS
Hemadsorption During and After Cardiopulmonary Bypass to Modulate the Inflammatory Response
NA trial testing CytoSorb in Inflammatory Response in 40 participants. Status unknown.
1 November 2021
Quick facts
| Lead sponsor | University Magna Graecia |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | prevention |
| Enrollment | 40 |
| Start date | 15 November 2020 |
| Primary completion | 1 November 2021 |
| Estimated completion | 15 November 2021 |
| Sites | 1 location across Italy |
Drugs / interventions tested
- CytoSorb
- Control
Conditions studied
- Inflammatory Response — all drugs for Inflammatory Response →
- Chronic Renal Disease — all drugs for Chronic Renal Disease →
- Cardiac Surgery — all drugs for Cardiac Surgery →
Sponsor
University Magna Graecia
Who can join
65 and older, any sex, with Inflammatory Response or Chronic Renal Disease. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Chronic kidney disease (CKD) is a risk factor for the development of cardiovascular disease, which increases the risk of death after cardiac surgery. High interleukin 6 (IL-6) blood levels is commonly observed in patients with CKD, and this is particularly high after cardiac surgery. High IL-6 levels are also associated with increased long-term mortality rate after cardiac surgery. To date, the use of ultrafiltration or endotoxin adsorption systems were not found to improve the clinical outcome, although able to reduce the inflammatory mediators concentrations. In the last years, a new extracorporeal hemadsorption filter (CytoSorb) has been developed for removal of inflammatory cytokines and it has been approved by the European Union. However, data lack about the impact on clinical outcome of the use of CytoSorb in patients with CKD undergoing cardiac surgery with cardio-pulmonary bypass (CPB). The investigators have therefore designed this pilot prospective randomized trial to evaluate the efficacy the intraoperative use of CytoSorb for cytokines removal to prevent the inflammatory response associated with the cardiac surgery and complications in patients with CKD.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04157647
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of CytoSorb
Trials testing the same drug.
- NCT06079021 — COOLEY- Study: aCute On chrOnic Liver failurE Using the cYtosorb Device · NA · recruiting
- NCT05242289 — Cytokine Adsorption in Lung Transplantation · NA · completed
- NCT05259514 — CytoSorb SAH Trial · NA · terminated
- NCT05077124 — Safe and Timely Antithrombotic Removal (STAR) Registry · recruiting
- NCT05027529 — ECMOsorb Trial - Impact of a VA-ECMO in Combination With CytoSorb in Critically Ill Patients With Cardiogenic Shock · NA · completed
Other recruiting trials for Inflammatory Response
Currently open trials in the same condition.
- NCT06450704 — Cerebral and Anti-inflammatory Response Through Exercise - Mechanisms In Depressive Disorders · NA · recruiting
- NCT06519487 — Social Experiences and Demographic Factors in the Regulation of Immune Cells · NA · recruiting
- NCT06434701 — Severe COVID-19 Infection in Children Presenting to EDs in Israel and England · NA · recruiting
- NCT06491966 — Clinical Outcomes and Inflammatory Responses in Viral vs. Bacterial Sepsis · recruiting
- NCT06342024 — Pistachio Consumption on Inflammatory Markers and Lean Body Mass · NA · active not recruiting
Other University Magna Graecia trials
Trials by the same sponsor.
- NCT07173660 — Consensus Statements on Deep Brain Stimulation in Patients With Parkinson's Disease · not yet recruiting
- NCT06830460 — Measurement of the Optic Nerve Diameter in Different Healthcare Operators · NA · not yet recruiting
- NCT06274931 — Analysis of the Pulmonary Microbiome · unknown
- NCT05398289 — FOUR-SIX TRIAL for the Treatment of Enterococcal Endocarditis · Phase 4 · not yet recruiting
- NCT05681962 — Practice of Oxygenation and Respiratory Support During Fiberoptic Bronchoscopy · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04157647 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University Magna Graecia
- Last refreshed: 12 November 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04157647.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing