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OpenTrials
Completed

NCT Number: NCT06321874

Effects of Oxygen After Abdominal Oncological Surgery

The aims of the research is to determine whether a Hyperoxic intermittent stimuli protocol can increase reticulocyte counts, signififying a rise in EPO production, in patients undergoing abdominal surgery

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Khalife Maher

Brussels, 1000, Belgium

About this study

For anemia treatment in cancer patients, human recombinant erythropoietin is often used. However, its application is constrained due to high costs, side effects, and limited availability in some regions. This research and clinical exploration aim to identify an tool alternative to transfusion.

Randomization was conducted post-surgery in a 1:1 ratio across groups: Normobaric Oxygen Paradox (NOP) group, and a control (CTR) group. The NOP group received 60% oxygen for two hours on days 1, 3, and 5 post-surgery using a venti-mask. The CTR group did not receive oxygen therapy during the post-operatory period starting from day 1. All patients could receive oxygen during the surgery and the first 24 hours post-surgery (day 0) as needed. The belonging to one group or the other was blinded to the laboratory staff.

Pre-surgery, all patients were administered an oral benzodiazepine. General anesthesia was employed, potentially combined with epidural techniques and standard anesthesia monitors were used. The choice of anesthesia technique was at the discretion of the anesthetist. During surgery, patients received 40-50% FiO2 ventilation and were extubated at the surgery's end. Post-surgery, patients were admitted to the ICU for at least 24 hours, receiving oxygen if saturation dropped below 98%. The oxygen protocol commenced 24 hours after ICU admission (day 1). The transfusion threshold was set at 8 g/dl with clinical signs.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients undergoing abdominal oncological surgery

Exclusion criteria

  • GFR<60 ml/minute and/ or creatinine serum level > 2mg/dl
  • Transfusion of red blood cells per or postoperatively
  • Bleeding requiring repeated transfusions during or after surgery
  • Severe respiratory syndrome necessitating continuous oxygen
  • Intolerance to oxygen mask

Treatment and study plan

Oxygen

Procedure

Primary outcomes

  1. Percentage change in reticulocyte count

    Time frame: 6 days

    Percentage change in reticulocyte count from baseline to day six within each group

Secondary outcomes

  1. haematocrit levels mesure

    Time frame: 6 days

    haematocrit levels mesured at baseline and on day six

  2. haemoglobin levels mesure

    Time frame: 6 days

    haemoglobin levels mesured at baseline and on day six

Sponsors and collaborators

Lead sponsor

Jules Bordet Institute

Other

Registry information

Official study title

Exploring Postoperative Effects of Hyperoxic Intermittent Stimuli on Reticulocytes Levels in Abdominal Surgery: A Randomized Single-blind Study

Acronym: EPHIRAS

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Mar 20, 2024
Registry last updated
Apr 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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