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

Phase 1

• Conditions: Acute kidney injury which is associated with on-pump cardiac surgery; Therapeutic area: Not possible to specify

• Registration Number: EUCTR2013-004607-39-BE
• Lead Sponsor: CUB Hopital Erasme

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-01-08
• Last Update Posted: 14 March 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

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 < 55 ml/min/1.73m2 as defined by CKD-EPI equation.
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 22
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 8

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.