To investigate the effect of methylprednisolone on inflammatory cytokines and urinary N-acetyl-beta-D-glucosaminidase/creatinine ratio in elective aortic aneurysm repair.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-000195-41-GB

Enrollment

Registered

2005-05-27

Start date

2005-06-14

Completion date

Unknown

Last updated

2019-11-25

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

Conditions

Abdominal aortic aneurysm, unruptured.

Interventions

Trade Name: Solu-Medrone Product Name: Solu-Medrone Pharmaceutical Form: Powder for injection* INN or Proposed INN: Methylprednisolone sodium succinate

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Patients who are found to have an aortic aneurym larger than 6 cm diameter and who elect to undergo elective open surgical ( as opposed to radiological endovascular stenting) repair of the aneurysm. - Males and Females - Aged between 18 and 75 years 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: - Patients who have diabetes mellitus. - Patients with an active proven bacterial or viral infection. - Pre-existing cortico-steroid therapy. - Systemic fungal infection. - Acute renal failure or renal replacement therapy. - Patients who are pregnant or lactating will be excluded.

Design outcomes

Primary

Measure	Time frame
Main Objective: To determine whether patients undergoing repair of an abdominal aortic aneurysm can be protected from renal dysfunction in the post-operative period by the use of corticosteroids given at the time of induction of anaesthesia.;Secondary Objective: To study markers of renal tubular dysfunction and the pattern of inflammatory mediator production in this group of patients.;Primary end point(s): Urinary N-acetyl-beta-glucosaminidase/creatinine ratio. Used as a marker of subclinical proximal convoluted renal tubular dysfunction.	—

Measure

Time frame

Main Objective: To determine whether patients undergoing repair of an abdominal aortic aneurysm can be protected from renal dysfunction in the post-operative period by the use of corticosteroids given at the time of induction of anaesthesia.;Secondary Objective: To study markers of renal tubular dysfunction and the pattern of inflammatory mediator production in this group of patients.;Primary end point(s): Urinary N-acetyl-beta-glucosaminidase/creatinine ratio. Used as a marker of subclinical proximal convoluted renal tubular dysfunction.

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Countries

United Kingdom

Outcome results

None listed

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