Effects of oxygen treatment on mechanisms involved in tissue damage caused by lack of oxygen.

Effects of oxygen treatment on mechanisms involved in ischemia-reperfusion injury: A pilot study in healthy volunteers. - Oxygen treatment and markers of ischemia-reperfusion injury

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-002282-30-SE

Enrollment

Registered

2014-06-17

Start date

2014-07-30

Completion date

Unknown

Last updated

2024-10-21

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

Conditions

Study performed in healthy male vonlunteers.

Interventions

Trade Name: Lipitor, tablets 80 mg Pharmaceutical Form: Coated tablet INN or Proposed INN: ATORVASTATIN CAS Number: 134523-00-5 Concentration unit: mg milligram(s) Concentration type: equal Concentrat

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 1. Male gender 2. Age 18-40 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 36 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Any chronic disease - Any acute disease or trauma within 30 days of study inclusion -Any regular or temporary medication within 10 days of study inclusion - Inability to communicate, understand or follow study instructions - Participant in another on-going interventional trial - Previous Typhim Vi® vaccination - Known allergy to any of the components of the intervention (Typhim Vi® and Lipitor®) - Current smoker

Design outcomes

Primary

Measure	Time frame
Main Objective: To study the effect of oxygen treatment on biomarkers reflecting the processes involved in myocardial ischemia-reperfusion injury.;Secondary Objective: To evaluate the effect of Atorvastatin on those biomarkers in oxygen-treated healthy volunteers with a low-grade induced inflammation.;Primary end point(s): Plasma levels of MMPs, TIMPS, markers of apoptosis, markers of inflammation and markers of oxidative stress ;Timepoint(s) of evaluation of this end point: Baseline and 3 hours, 6 hours and 8 hours after initiation of treatment.	—

Measure

Time frame

Main Objective: To study the effect of oxygen treatment on biomarkers reflecting the processes involved in myocardial ischemia-reperfusion injury.;Secondary Objective: To evaluate the effect of Atorvastatin on those biomarkers in oxygen-treated healthy volunteers with a low-grade induced inflammation.;Primary end point(s): Plasma levels of MMPs, TIMPS, markers of apoptosis, markers of inflammation and markers of oxidative stress ;Timepoint(s) of evaluation of this end point: Baseline and 3 hours, 6 hours and 8 hours after initiation of treatment.

—

Secondary

Measure	Time frame
Secondary end point(s): Levels of mRNA of markers of apoptosis, MMP-2 and TIMP-2 and markers of oxidative stress. Platelet aggregation.;Timepoint(s) of evaluation of this end point: Baseline and 3 hours, 6 hours and 8 hours after initiation of treatment.	—

Countries

Sweden

Contacts

Public ContactLennart Nilsson

County council of Ostergotland

lennart.nilsson@liu.se+46732703844

Outcome results

None listed

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