Clinical trial NCT06321874: Effects of Oxygen After Abdominal Oncological Surgery
Official title: Exploring Postoperative Effects of Hyperoxic Intermittent Stimuli on Reticulocytes Levels in Abdominal Surgery: A Randomized Single-blind Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Abdominal Cancer
Keywords: oncology
abdominal surgery
oxygen
Lead sponsor: Jules Bordet Institute
Sponsor class: OTHER
First posted: 2024-03-20
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: BASIC_SCIENCE

Brief summary: 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

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage change in reticulocyte count
timeFrame: 6 days
Secondary outcomes:
measure: haematocrit levels mesure
timeFrame: 6 days
measure: haemoglobin levels mesure
timeFrame: 6 days
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Khalife Maher
Study officials:
affiliation: Jules Bordet Institute
name: Maher Khalife, MD
role: PRINCIPAL_INVESTIGATOR
References: