Effects of Oxygen After Abdominal Oncological Surgery

Abdominal Cancer Clinical Trial

— EPHIRAS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06321874
• Other study ID #: EPHIRAS
• Status: Completed
• Phase: N/A
• Start date: January 1, 2011
• Est. completion date: November 1, 2011

Study information

• Verified date: February 2024
• Source: Jules Bordet Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: November 1, 2011
• Est. primary completion date: November 1, 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Abdominal Cancer

Intervention

Procedure:
• Oxygen

Locations

Country	Name	City	State
Belgium	Khalife Maher	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Jules Bordet Institute

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage change in reticulocyte count	Percentage change in reticulocyte count from baseline to day six within each group	6 days
Secondary	haematocrit levels mesure	haematocrit levels mesured at baseline and on day six	6 days
Secondary	haemoglobin levels mesure	haemoglobin levels mesured at baseline and on day six	6 days