Renal protection by radical-scavenging with N-acetylcysteine in cardiac surgery patients

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN94244587

Enrollment

Registered

2006-08-29

Start date

2007-01-01

Completion date

Unknown

Last updated

2015-01-13

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

Conditions

Renal dysfunction induced by cardiopulmonary bypass (CPB) during cardiac surgery Urological and Genital Diseases Renal dysfunction induced by cardiopulmonary bypass (CPB) during cardiac surgery

Interventions

NAC at 100 mg per kg of body weight into the CPB prime followed by NAC infusion at 20 mg per kg of bodyweight per hour until the end of CPB versus placebo (25 patients for each group). In addition to

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Male or female 2. No renal dysfunction requiring hemodialysis/hemofitration 3. Isolated coronary artery disease 4. Left ventricular ejection fraction more than 40%

Exclusion criteria

Exclusion criteria: 1. Pregnancy 2. Aged over 18 years

Design outcomes

Primary

Measure	Time frame
Postoperative renal function assessed by means of the following variables in plasma and urine: 1. Creatinine concentration (primary variable) 2. Cystatin C concentration (co-primary variable)	—

Secondary

Measure	Time frame
1. Urea, retinol-binding protein, albumine, alpha1-microglobulin 2. Quantity of post-surgery diuretic medication, serum creatinine clearance 3. Oxidative stress variable in plasma and urine: 8-isoprostaglandinF2a	—

Countries

Germany

Outcome results

None listed

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