Study on the effects of EA-230 on the immune system following heart surgery

Randomized double blind placebo-controlled phase II study on the effects of EA-230 on the innate immune response following on-pump cardiac surgery - Immunomodulation of EA-230 following on-pump CABG

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-005600-28-NL

Enrollment

160

Registered

2016-02-11

Start date

2016-06-17

Completion date

Unknown

Last updated

2020-11-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Systemic inflammatory respons (SIRS) and associated acute kidney injury (AKI)

Interventions

Trade Name: New pharmaceutical compound. The answer on section D2.1 should be "no". But due to persisting error in the form, this answer could not be entered. This error had been notified to the servi

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients scheduled for elective on-pump CABG surgery, with or without valve replacement 2. Written informed consent to participate in this trial prior to any study-mandated procedure. 3. Patients aged >18, both male and female. 4. Patients have to agree to use a reliable way of contraception with their partners from study entry until 3 months after study drug administration. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 160 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. Immune compromised • Solid organ transplantation • Known HIV • Pregnancy • Systemic use of immunosuppressive drugs 2. Non-elective/Emergency surgery 3. Hematological disorders • Known disorders from myeloid and/or lymphoid origin • Leucopenia (leucocyte count < 4x10^9/L) 4. Use of iohexol contrast <48 hours before start of the first study procedure 5. Known hypersensitivity to any excipients of the drug formulations used 6. Treatment with investigational drugs or participation in any other intervention clinical trial within 30 days prior to study drug administration 7. Inability to personally provide written informed consent (e.g. for linguistic or mental reasons) 8. Known or suspected of not being able to comply with the trial protocol.

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess safety and tolerability of EA-230 in patients undergoing cardiac surgery with cardiopulmonary bypass. To assess the anti-inflammatory effect of EA-230 in patients with systemic inflammation following cardiac surgery. ;Secondary Objective: To assess the effects on clinical outcomes in this patient group. ;Primary end point(s): Safety: • Adverse events • Vital signs (blood pressure and heart rate) • Safety laboratory parameters (Hb, Ht, leucocytes, thrombocytes, leucocyte differential blood count, sodium, potassium, creatinine, urea, alkaline phosphatase, ALT, AST, ?GT, CK, CRP) Key-efficacy endpoints: • Blood plasma levels of IL-6 • GFR measured by plasma clearance of iohexol ;Timepoint(s) of evaluation of this end point: Adverse events: Continous form start study till end of study (90days) Vital signs: During treatment and hospital stay Safety laboratory parameters:During treatment and hospital stay Blood plasma levels of IL-6: Baseline, start ECC pump, stop ECC pump, t=2 hours after stop ECC pump, t=4 hours after stop ECC pump, t=6 hours after stop ECC pump, t=24 hours after stop ECC pump GFR measured by plasma clearance of iohexol: Day before surgery and day after surgery	—

Measure

Time frame

Main Objective: To assess safety and tolerability of EA-230 in patients undergoing cardiac surgery with cardiopulmonary bypass. To assess the anti-inflammatory effect of EA-230 in patients with systemic inflammation following cardiac surgery. ;Secondary Objective: To assess the effects on clinical outcomes in this patient group. ;Primary end point(s): Safety: • Adverse events • Vital signs (blood pressure and heart rate) • Safety laboratory parameters (Hb, Ht, leucocytes, thrombocytes, leucocyte differential blood count, sodium, potassium, creatinine, urea, alkaline phosphatase, ALT, AST, ?GT, CK, CRP) Key-efficacy endpoints: • Blood plasma levels of IL-6 • GFR measured by plasma clearance of iohexol ;Timepoint(s) of evaluation of this end point: Adverse events: Continous form start study till end of study (90days) Vital signs: During treatment and hospital stay Safety laboratory parameters:During treatment and hospital stay Blood plasma levels of IL-6: Baseline, start ECC pump, stop ECC pump, t=2 hours after stop ECC pump, t=4 hours after stop ECC pump, t=6 hours after stop ECC pump, t=24 hours after stop ECC pump GFR measured by plasma clearance of iohexol: Day before surgery and day after surgery

—

Secondary

Measure	Time frame
Secondary end point(s): Inflammatory • Plasma levels of other cytokines: TNFa, IL-8, IL-10, IL-1RA, MCP-1, IL12-p70, MIP1a , MIP1ß • Body temperature • SIRS score • SOFA score Outcome • Length of stay (ICU and general) • 90 days mortality • Apache score Renal: • Creatinine clearance using urine and plasma creatinine • Urine markers: KIM-1, NGAL, L-FABP, TIMP-2*IGFBP-7 • Urine output (per 4 hrs during ICU-length of stay ) • Urine biochemistry: Urea, sodium, Creatinine • Incidence of AKI stages, according to RIFLE-criteria • Need for Renal replacement therapy (RRT) and days of RRT Cardiovascular • Vasopressor use, expressed as inotropic score • Fluid therapy Pulmonary • Time until detubation • A-a O2gradient Pharmacokinetics • Blood plasma levels of EA-230 and, AUC, Cmax, terminal t1/2, Cl, V. ;Timepoint(s) of evaluation of this end point: cytokines: BBaseline, start ECC pomp, stop ECC pomp, t=2 uur na stop ECC pomp, t=4 uur na stop ECC pomp, t=6 uur na stop ECC pomp, t=24 uur na stop ECC pomp Lichaamstemperatuur, SIRS score, SOFA score, opname duur (ICU en algemeen), mortaliteit, Apache score, Creatinine klaring, Incidentie van AKI, niervervangende therapie: Gedurende ziekenhuisopname Urine markers en biochemie: dga na operatie Urine productie, vocht therapie, Vasopressor gebruik, tijd tot detubatie, A-a O2gradient: gedurende ICU-opname Pharmacokinetiek: Frequente sampling gedurdende studie medicatie behandeling tot 2 uur na stop van de infusie.	—

Measure

Time frame

Secondary end point(s): Inflammatory • Plasma levels of other cytokines: TNFa, IL-8, IL-10, IL-1RA, MCP-1, IL12-p70, MIP1a , MIP1ß • Body temperature • SIRS score • SOFA score Outcome • Length of stay (ICU and general) • 90 days mortality • Apache score Renal: • Creatinine clearance using urine and plasma creatinine • Urine markers: KIM-1, NGAL, L-FABP, TIMP-2*IGFBP-7 • Urine output (per 4 hrs during ICU-length of stay ) • Urine biochemistry: Urea, sodium, Creatinine • Incidence of AKI stages, according to RIFLE-criteria • Need for Renal replacement therapy (RRT) and days of RRT Cardiovascular • Vasopressor use, expressed as inotropic score • Fluid therapy Pulmonary • Time until detubation • A-a O2gradient Pharmacokinetics • Blood plasma levels of EA-230 and, AUC, Cmax, terminal t1/2, Cl, V. ;Timepoint(s) of evaluation of this end point: cytokines: BBaseline, start ECC pomp, stop ECC pomp, t=2 uur na stop ECC pomp, t=4 uur na stop ECC pomp, t=6 uur na stop ECC pomp, t=24 uur na stop ECC pomp Lichaamstemperatuur, SIRS score, SOFA score, opname duur (ICU en algemeen), mortaliteit, Apache score, Creatinine klaring, Incidentie van AKI, niervervangende therapie: Gedurende ziekenhuisopname Urine markers en biochemie: dga na operatie Urine productie, vocht therapie, Vasopressor gebruik, tijd tot detubatie, A-a O2gradient: gedurende ICU-opname Pharmacokinetiek: Frequente sampling gedurdende studie medicatie behandeling tot 2 uur na stop van de infusie.

—

Countries

Netherlands

Contacts

Public ContactRoger van Groenendael

Radboud University Medical Center

r.vangroenendael@radoudumc.nl

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026