In short
There are currently 2 clinical trials investigating treatments and interventions for hypoxia and conditions related to low oxygen levels in the body. These studies are taking place in Austria and Sweden, exploring different approaches including oxygen therapy after surgery and medication to improve the body's response to low oxygen levels in diabetes patients.
Clinical trial locations
- Austria
- Sweden
Oxygen Therapy to Prevent Breathing Problems After Non-Cardiac Surgery in Patients at Risk for Postoperative Complications
This clinical trial, known as the AIOLOS trial, is being conducted in Austria and focuses on preventing temporary drops in blood oxygen levels after surgery. The study aims to determine whether providing supplemental oxygen therapy can help patients recover more safely after undergoing general or urological procedures.
Main focus: The trial investigates whether delivering oxygen through a nasal tube at 3 liters per minute can reduce the time patients spend with low blood oxygen levels (below 90%) during the first two days after surgery. Researchers will use a pulse oximeter, a simple device that clips onto a finger, to continuously monitor oxygen levels. The study will also assess recovery quality, the occurrence of confusion or delirium, and surgical site infections within 30 days of the operation.
Inclusion criteria: Patients must be scheduled for elective non-cardiac surgery (general or urological procedures) with at least one overnight stay before surgery and two planned nights in hospital afterward. Participants must be 60 years or older and have at least one risk factor for postoperative complications, such as elevated heart-related proteins, a history of heart or blood vessel disease, being 75 or older, current or recent smoking, diabetes, high cholesterol, high blood pressure, or irregular heartbeat. The surgery must be performed under general anesthesia, and patients must provide written informed consent.
Exclusion criteria: The trial excludes patients who are not at risk for postoperative complications, those outside the specified age range, and individuals who belong to vulnerable populations requiring special protection or care.
Treatment being tested: The investigational intervention is oxygen therapy delivered through a nasal cannula at a flow rate of 3 liters per minute. This approach is designed to maintain adequate oxygen levels in the blood after surgery and prevent temporary oxygen desaturation.
Study on Deferoxamine to Improve Hypoxia Response in Type 1 Diabetes Patients
This clinical trial is taking place in Sweden and examines whether a medication called Desferal (deferoxamine) can help people with Type 1 Diabetes respond better to situations where their body experiences low oxygen levels. Type 1 Diabetes is a condition where the body cannot produce insulin, the hormone needed to control blood sugar levels.
Main focus: The study aims to determine if Desferal can improve how the body reacts to hypoxia in patients with Type 1 Diabetes. Researchers will monitor specific cells and substances in the blood related to blood vessel growth and oxygen response. The trial uses a cross-over design, meaning participants will receive both the active medication and a placebo at different times, allowing for direct comparison. The study will also evaluate various heart and lung functions to understand the treatment's broader effects.
Inclusion criteria: Patients must have Type 1 Diabetes for a duration between 5 and 40 years, with HbA1c levels (a measure of blood sugar control over 2 to 3 months) between 55 and 100 mmol/mol. Participants must be between 18 and 55 years old and have a normal ECG showing no significant heart problems. Female participants must either be postmenopausal, surgically sterile, or use highly effective contraception during the study and for 30 days after the final visit. All participants must provide signed informed consent.
Exclusion criteria: The trial excludes patients who do not have Type 1 Diabetes, those not experiencing issues with their body's reaction to low oxygen levels, individuals outside the specified age range, and those who belong to vulnerable populations.
Treatment being tested: Desferal (deferoxamine mesilate) is the investigational drug in this trial. It is given as an intravenous injection or infusion to see if it can improve the body's response to hypoxia in Type 1 Diabetes patients. Deferoxamine works at the molecular level by binding to excess iron in the body, which may help reduce oxidative stress and improve how cells function under low oxygen conditions.
Summary
These two clinical trials represent distinct approaches to addressing hypoxia-related challenges in different patient populations. The Austrian trial focuses on a practical intervention—supplemental oxygen therapy—for elderly surgical patients at risk for complications, while the Swedish trial explores a pharmacological solution for improving hypoxia response in Type 1 Diabetes patients using deferoxamine, an iron chelator.
The trials are geographically distributed across Central and Northern Europe, with each study targeting specific patient groups and medical situations. The Austrian study emphasizes prevention of postoperative complications through simple oxygen supplementation, while the Swedish research investigates the more complex relationship between diabetes, iron metabolism, and the body's ability to respond to low oxygen conditions. Both trials are expected to provide valuable insights into managing and treating hypoxia-related health challenges in their respective patient populations.
