Abdominal CancerEPHIRASNCT06321874
Effects of Oxygen After Abdominal Oncological Surgery
A study testing Oxygen in people with Abdominal Cancer, run by Jules Bordet Institute at 1 site in Belgium.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdominal Cancer
- What is being tested?
- Oxygen
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Jan 2011to 1 Nov 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients undergoing abdominal oncological surgery
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- Abdominal Cancer
- Being tested
- Oxygen
- Keywords
- oncology, abdominal surgery, oxygen
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxygenProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Normobaric Oxygen Paradox (NOP) group | Experimental | The NOP group received 60% oxygen for two hours on days 1, 3, and 5 post-surgery using a venti-mask. Receives: Procedure: Oxygen |
| Control (CTR) group | No intervention | The CTR group did not receive oxygen therapy during the post-operatory period starting from day 1. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage change in reticulocyte count
Percentage change in reticulocyte count from baseline to day six within each group
Measured: 6 days
Secondary outcomes (2)
haematocrit levels mesure
haematocrit levels mesured at baseline and on day six
Measured: 6 days
haemoglobin levels mesure
haemoglobin levels mesured at baseline and on day six
Measured: 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2024
- Study start1 Jan 2011
- Primary completion1 Nov 2011
- Study completion1 Nov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jules Bordet Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maher Khalife, MD, Principal investigator, Jules Bordet Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06321874
- Sponsor's protocol ID
- EPHIRAS
- Acronym
- EPHIRAS
- Status last verified
- Feb 2024
- First submitted
- 22 Feb 2024
- Last updated
- 10 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring Postoperative Effects of Hyperoxic Intermittent Stimuli on Reticulocytes Levels in Abdominal Surgery: A Randomized Single-blind Study
- ClinicalTrials.gov ID
- NCT06321874
- Acronym / sponsor ID
- EPHIRAS / EPHIRAS
- Conditions
- Abdominal Cancer
- Keywords
- oncology, abdominal surgery, oxygen
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Jules Bordet InstituteUniversity, hospital or other
- Study start
- 1 Jan 2011 (actual)
- Primary completion
- 1 Nov 2011 (actual)
- Study completion
- 1 Nov 2011 (actual)
- First posted
- 20 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Normobaric Oxygen Paradox (NOP) group | Experimental | Procedure: OxygenThe NOP group received 60% oxygen for two hours on days 1, 3, and 5 post-surgery using a venti-mask. |
| Control (CTR) group | No intervention | –The CTR group did not receive oxygen therapy during the post-operatory period starting from day 1. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients undergoing abdominal oncological surgery
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oxygen | Procedure or surgery | Normobaric Oxygen Paradox (NOP) group |
Primary outcome
Percentage change in reticulocyte count
Time frame: 6 days
Percentage change in reticulocyte count from baseline to day six within each group
2 secondary outcomes
haematocrit levels mesure
Time frame: 6 days
haemoglobin levels mesure
Time frame: 6 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maher Khalife, MD principal investigator
Jules Bordet Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oxygen in people with Abdominal Cancer, run by Jules Bordet Institute at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage change in reticulocyte count (time frame: 6 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2024.