The effects of improving oxygen concentration in the reduction of dialysis induced myocardial stunning – A pilot study - Oxygenation and myocardial stunning

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-004012-31-GB

Enrollment

Registered

2009-04-16

Start date

2009-07-06

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

Chronic renal failure patients who are receiving haemodialysis treatment MedDRA version: 9.1 Level: LLT Classification code 10066623 Term: Chronic haemodialysis

Interventions

Trade Name: Oxygen Product Name: Oxygen Pharmaceutical Form: Inhalation gas CAS Number: 7782447 Other descriptive name: OXYGEN

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients on HD treatment at least 3times/week. 2. Willing to provide consent. 3. Male and female, age>18 years old. 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: 1. Dialysis for <4 months 2. Unable to obtain echocardiographic data of sufficient quality to allow analysis 3. Cardiac transplant recipients 4. NYHA IV heart failure 5. Chronic obstructive airway disease, other chronic/acute lung condition exacerbating hypoxia and/or unable to tolerate O2 therapy. 6. Patients on long term oxygen therapy (LTOT). 7. Pregnant women or female subjects in childbearing age.

Design outcomes

Primary

Measure	Time frame
Main Objective: Test if increasing inhaled O2 concentration at 4 litre/minute via nasal cannulae, reduces dialysis related myocardial stunning. ; Secondary Objective: 1. Observe the difference in the haemodynamic variables during HD including the frequency and severity of intradislytic hypotension and pulse rate in response to inhaled O2 at 4litre/min. 2. Observe the difference in the global left ventricular ejection fraction with and without inhaled O2 at 4litre/min, pre and post dialysis. ;Primary end point(s): The response to O2 administration at 4 litre/minute during HD on the frequency and severity of myocardial stunning, measured by the number of the new Regional Wall Motion Abnormalities (RWMA) and the reduction in the myocardial contractility in each of the segment affected by RWMAs respectively	—

Measure

Time frame

Main Objective: Test if increasing inhaled O2 concentration at 4 litre/minute via nasal cannulae, reduces dialysis related myocardial stunning. ; Secondary Objective: 1. Observe the difference in the haemodynamic variables during HD including the frequency and severity of intradislytic hypotension and pulse rate in response to inhaled O2 at 4litre/min. 2. Observe the difference in the global left ventricular ejection fraction with and without inhaled O2 at 4litre/min, pre and post dialysis. ;Primary end point(s): The response to O2 administration at 4 litre/minute during HD on the frequency and severity of myocardial stunning, measured by the number of the new Regional Wall Motion Abnormalities (RWMA) and the reduction in the myocardial contractility in each of the segment affected by RWMAs respectively

—

Countries

United Kingdom

Outcome results

None listed

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