The role of the antioxidants ascorbic acid and n-acetylcysteine in the attenuation of ischaemia reperfusion injury in a human model

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-004613-10-IE

Enrollment

Registered

2008-07-14

Start date

2008-09-12

Completion date

Unknown

Last updated

2025-04-14

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

Conditions

Ischaemia reperfusion injury MedDRA version: 9.1 Level: LLT Classification code 10063837 Term: Reperfusion injury MedDRA version: 9.1 Level: PT Classification code 10063837 Term: Reperfusion injury

Interventions

Trade Name: Rubex effervescent Pharmaceutical Form: Effervescent tablet INN or Proposed INN: ASCORBIC ACID CAS Number: 50817 Other descriptive name: Vitamin C Concentration unit: g gram(s) Concentrati

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients undergoing elective knee surgery Age range 18-60 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) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Smokers Patients on vitamin supplements Patients on anti-inflammatory medications Patients with inflammatory medical conditions (eg Crohn's disease, UC, SLE, RA) Patients with diabetes Patients with a history of renal calculi Pregnant women

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of this project is to demonstrate that the administration of an antioxidant substance attenuates the inflammatory response of the body to ischaemia reperfusion injury (IRI), thereby reducing or preventing the potential deleterious effects that may result from IRI;Secondary Objective: We intend to show that safe, cheap and readily available antioxidant substances (eg vitamin C and N-Acetylcysteine) have a measurable clinical role in the potential prophylaxis of compartment syndrome and may also have a role in prolonging the safe tourniquet time for elective and trauma orthopaedic surgery. These clinical applications of our research would have the potential to change current practice and improve patient welfare.;Primary end point(s): This study aims to observe the inflammatory reaction in the participating subjects to an IRI caused by tourniquet application in the setting of elective surgery. We intend to compare the inflammatory response between groups taking antioxidants (vitamin C or NAC) and those receiving placebo. As this study has a limited duration, the primary endpoint is the final clinical review at 6 weeks post op.	—

Measure

Time frame

Main Objective: The primary objective of this project is to demonstrate that the administration of an antioxidant substance attenuates the inflammatory response of the body to ischaemia reperfusion injury (IRI), thereby reducing or preventing the potential deleterious effects that may result from IRI;Secondary Objective: We intend to show that safe, cheap and readily available antioxidant substances (eg vitamin C and N-Acetylcysteine) have a measurable clinical role in the potential prophylaxis of compartment syndrome and may also have a role in prolonging the safe tourniquet time for elective and trauma orthopaedic surgery. These clinical applications of our research would have the potential to change current practice and improve patient welfare.;Primary end point(s): This study aims to observe the inflammatory reaction in the participating subjects to an IRI caused by tourniquet application in the setting of elective surgery. We intend to compare the inflammatory response between groups taking antioxidants (vitamin C or NAC) and those receiving placebo. As this study has a limited duration, the primary endpoint is the final clinical review at 6 weeks post op.

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Countries

Ireland

Outcome results

None listed

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