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Does N-Acetylcysteine (Parvolex) prophylaxis reduce the incidence of renal impairment after on pump Coronary artery bypass surgery? A prospective randomised controlled trial.

Does N-Acetylcysteine (Parvolex) prophylaxis reduce the incidence of renal impairment after on pump Coronary artery bypass surgery? A prospective randomised controlled trial.

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2006-006815-62-GB
Enrollment
224
Registered
2007-04-17
Start date
2007-05-22
Completion date
Unknown
Last updated
2019-12-16

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

Conditions

Renal impairment after coronary artery byapass surgery MedDRA version: 9.1 Level: LLT Classification code 10006894 Term: CABG

Interventions

Trade Name: Parvolex Product Name: Acetylcysteine Pharmaceutical Form: Solution for injection Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 200- Pha

Sponsors

University Hospitals of South Manchester NHS Foundation Trust
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients undergoing elective coronary artery bypasssurgery at Wythenshawe Hospital Manchester 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Urgent and emergency cases Patients with history of hypersensitivity to N-Acetylcysteine Patients already taking N-Acetylcysteine Patients with existing renal failure (creatinine more than 120mmol/l –upper limit of normal range in our laboratory

Design outcomes

Primary

MeasureTime frame
Main Objective: To find out whether prophylactic use of N-Acetylcysteine decreases the incidence of renal impairment after cardiac surgery;Secondary Objective: To find out whether prophylactic N-Acetylcysteine has effect on the length of ICU/HDU stay;Primary end point(s): serum creatinine levels first 48 hrs

Countries

United Kingdom

Outcome results

None listed

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