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Effects of single and multiple oxygen administration under elevated ambient pressure on the healthy human kidney

Effects of single and multiple oxygen administration under elevated ambient pressure on the healthy human kidney - RENOX

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
DRKS
Registry ID
DRKS00028147
Enrollment
20
Registered
2022-02-16
Start date
2022-02-22
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

TINNITUS

Interventions

Group 1: All patients get blood drawn before and after the first hyperbaric oxygen therapy, as well as after the fifth and after the tenth therapy. Also, urine samples are given by all patients before

Sponsors

HBO-Zentrum Euregio Aachen
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: HBO therapy in the context of a hearing loss/ tinnitus - No known previous kidney diseases - No known vascular diseases - GFR > 90m/min (via CKD-EPI) - No use of permanent medication with influence on renal function - Sufficient knowledge of German

Exclusion criteria

Exclusion criteria: - GFR < 90ml/min - Diseases with limitation of endocrine and exocrine renal function - Known intolerance to high ambient pressures with inability to equalize pressure (via Valsalva maneuver). Exclusion is based on patient history and symptoms. - Diseases of the middle ear - claustrophobia - Pulmonary disorders, such as severe bronchial asthma, emphysema, pneumothorax, acute infectious diseases - Acute upper respiratory tract and/or sinus infections with sinunasal congestion ("stuffy nose" or rhinitis) - Non-removable implants such as pacemakers, drug pumps, breast implants depending on manufacturer's instructions - Pregnancy and lactation - Severe cardiovascular diseases, in particular uncontrolled or poorly controlled arterial hypertension or heart failure - Sickle cell anemia - Condition following surgical procedures on the chest, ear or eye - seizure disorders - Taking medications that lower the seizure threshold (e.g., antidepressants) - Persistent foramen ovale (PFO) - Known vascular diseases

Design outcomes

Primary

MeasureTime frame
The primary endpoints will be measured using laboratory analysis of blood and urine samples. The primary endpoints are: 1.Hyperbaric oxygen therapy causes adjustments in renal metabolism that can be detected by urinary parameters. 2.Repeated hyperbaric oxygen therapy induces responses in the body that resemble intermittent hypoxia.

Secondary

MeasureTime frame
The following secondary hypotheses are put forward: 1. even single hyperbaric oxygen therapy has a detectable effect on metabolic adaptations of the kidney. 2. repeated hyperbaric oxygen therapy stimulates hematopoietic processes, primarily Erythropoetin formation.

Countries

Germany

Contacts

Public ContactUllrich Siekmann

HBO-Zentrum Euregio Aachen

renox-studie@web.de0241 84044

Outcome results

None listed

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