Effects of Oxygen After Abdominal Oncological Surgery (EPHIRAS)

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

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

Study Overview

• Status: Completed
• Conditions: Abdominal Cancer
• Intervention / Treatment: Procedure: Oxygen

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.

• Study Type: Interventional
• Enrollment (Actual): 49
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, 1000
    • Khalife Maher

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Normobaric Oxygen Paradox (NOP) group; The NOP group received 60% oxygen for two hours on days 1, 3, and 5 post-surgery using a venti-mask.	Procedure: Oxygen
No Intervention: Control (CTR) group; The CTR group did not receive oxygen therapy during the post-operatory period starting from day 1.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage change in reticulocyte count	Percentage change in reticulocyte count from baseline to day six within each group	6 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
haematocrit levels mesure	haematocrit levels mesured at baseline and on day six	6 days
haemoglobin levels mesure	haemoglobin levels mesured at baseline and on day six	6 days

Collaborators and Investigators

• Sponsor: Jules Bordet Institute
• Investigators: Principal Investigator: Maher Khalife, MD, Jules Bordet Institute

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2011
• Primary Completion (Actual): November 1, 2011
• Study Completion (Actual): November 1, 2011

Study Registration Dates

• First Submitted: February 22, 2024
• First Submitted That Met QC Criteria: March 13, 2024
• First Posted (Actual): March 20, 2024

Study Record Updates

• Last Update Posted (Actual): April 10, 2024
• Last Update Submitted That Met QC Criteria: April 8, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: oncology; oxygen; abdominal surgery
• Other Study ID Numbers: EPHIRAS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No