Safety of preoperative administration of hemin to reduce the risk of acute kidney disease after cardiac surgery: a pilot study.

Safety of preoperative administration of hemin to reduce the risk of acute kidney injury after on-pump cardiac surgery: a pilot randomised study in double blind. - Hemin for the prevention of acute kidney injury in cardiac surgery

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-004607-39-BE

Enrollment

Registered

2014-01-08

Start date

2014-04-11

Completion date

Unknown

Last updated

2022-03-14

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

Conditions

Acute kidney injury which is associated with on-pump cardiac surgery

Interventions

Trade Name: Normosang Product Name: Normosang Pharmaceutical Form: Powder for solution for injection Pharmaceutical form of the placebo: Solution for injection/infusion Route of administration of the

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Adults, capable of giving consent personally ; elective on-pump cardiac surgery (ie. valvular surgery and/or CABG) ; high risk of postoperative acute kidney injury as defined by a renal STS score > 5.2% and/or basal estimated glomerular filtration rate =65 years) yes F.1.3.1 Number of subjects for this age range 8

Exclusion criteria

Exclusion criteria: Minor of age, pregnancy, CHILD C cirrhosis, infectious endocarditis, emergent cardiac surgery, preoperative end-stage renal disease, preoperative use of renal replacement therapy, transplanted organs, active neoplasia, allergy to one components of hemin

Design outcomes

Primary

Measure	Time frame
Main Objective: To demonstrate the safety of intravenous hemin in patients with high risk of acute kidney injury after on-pump cardiac surgery;Secondary Objective: To evaluate the efficiency of preoperative administration of hemin to reduce the incidence of postoperative acute kidney injury in the context of cardiac surgery.;Primary end point(s): Safety study: incidence of hemin-related side effects (superficial thrombophlebitis at the site of injection, headache), incidence of other complications;Timepoint(s) of evaluation of this end point: Every 24h after cardiac surgery until day 7 ; at the time of discharge.	—

Measure

Time frame

Main Objective: To demonstrate the safety of intravenous hemin in patients with high risk of acute kidney injury after on-pump cardiac surgery;Secondary Objective: To evaluate the efficiency of preoperative administration of hemin to reduce the incidence of postoperative acute kidney injury in the context of cardiac surgery.;Primary end point(s): Safety study: incidence of hemin-related side effects (superficial thrombophlebitis at the site of injection, headache), incidence of other complications;Timepoint(s) of evaluation of this end point: Every 24h after cardiac surgery until day 7 ; at the time of discharge.

—

Secondary

Measure	Time frame
Secondary end point(s): (1) Modulation of the severity and/or reduction of the incidence of postoperative acute kidney injury as defined by 2012 KDIGO criteria. (2) quantification of heme oxygenate induction at 24h;Timepoint(s) of evaluation of this end point: Every 24h after cardiac surgery until day 7 ; at the time of discharge.	—

Countries

Belgium

Contacts

Public ContactD. Jean-Michel HOUGARDY

CUB Hopital Erasme

nicole.lietaer@erasme.ulb.ac.be003225553532

Outcome results

None listed

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