Detection of the Correct Position of Intravenous LinePhase 2/3IVBICONCOLNCT01748097
Intravenous Bicarbonate To Verify The Correct Position of IV Catheters in Oncological Patients Oncological Patients Receiving Chemotherapy
A Phase 2/3 study testing sodium bicarbonate 4.2% in people with Detection of the Correct Position of Intravenous Line, run by Sheba Medical Center at 2 sites in Israel.
Trial summary
The investigators use bicarbonate injected to an intravenous line and the changes in the exhaled end-tidal carbon dioxide to verify whether the IV line is in the vein or surrounding tissue Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Detection of the Correct Position of Intravenous Line
- What is being tested?
- sodium bicarbonate 4.2%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 2 sitesIsrael
- Study dates
- Dec 2012to Dec 2013
- Phase
- Phase 2/3
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 18-80 oncological disease requires intravenous chemotherapy
Who cannot join
- 1. refusal to participate 2. lung disease acute or chronic sPo2 < 92%, PaCO2 > 50 3. renal failure Creatinine > 2 mg% 4. metabolic alkalosis HCO3 > 30 meq/L 5. medication that affect bicarbonate levels: Bicarbonate, Diamox, Fusid 6. obesity BMI > 38 7. congestive heart failure EF < 40 % or clinical signs of congestive heart failure
Trial locations and contacts
2 sites in 1 country.
Israel2 sites, 2 recruiting
- Recruiting
Sheba Medical Center Oncology
Tel HaShomer, Israel, 52621
ilan keidan, MD, 07235302754, ilan.keidan@sheba.health.gov.il
- Not yet recruiting
Oncology Clinic
Tel HaShomer, 52621
ilan keidan, MD, 972526669370, ilan.keidan@sheba.health.gov.il
About this study
Official title: Phase III Study to Assess the Utility of a New Innovative Technique Using Intravenous Bicarbonate to Verify the Correct Position of Patients Scheduled for Intravenous Bicarbonate
The investigators use bicarbonate injected to an intravenous line and the changes in the exhaled end-tidal carbon dioxide to verify whether the IV line is in the vein or surrounding tissue
Read the detailed description
The method was proved useful in previous phase I, II studies. Now the investigators move on to assess the method in a phase III study in oncological patients.
each patients which will be subjected to intravenous chemotherapy will be eligible ( see also inclusion/exclusion criteria).
Once consent obtained the patient will have an IV line placed. each line placed will be categorized by the clinical team into 3 categories:
- IV in place ready to use for chemotherapy ( good blood return)
- Doubtful position ( no blood return/ little blood return bu flushes well).
- IV not in place. Study design Category 1. IV bicarbonate 4.2% 20 cc and NS 20 cc in a randomized fashion Category 2. same as above Category 3. No injections
- Being tested
- sodium bicarbonate 4.2%
- Keywords
- infiltration, extravasation, sodium bicarbonate, capnography, end tidal carbon dioxide, chemotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sodium bicarbonate 4.2%Drug
| Study group | Role | What they receive |
|---|---|---|
| IV bicarbonate 4.2% 20 cc | Experimental | injecting 20cc 4.2% to a newly administered IV line Receives: Drug: sodium bicarbonate 4.2% |
| IV normal saline | Placebo comparator | injecting 20 cc normal saline to a newly administered IV line |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in exhaled end tidal co2
the injection of bicarbonate in a vein cause a rapid and distinct change in exhaled end-tidal CO2
Measured: 1-3 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2012 (estimated)
- Study startDec 2012
- Primary completionDec 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Detection of the Correct Position of Intravenous LineStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Collaborators
- Netherlands: Ministry of Health, Welfare and Sports
- Responsible party
- Principal investigator, Dr. Ilan Keidan, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01748097
- Sponsor's protocol ID
- IV BIC for IVONCOL
- Acronym
- IVBICONCOL
- Status last verified
- Dec 2012
- First submitted
- 10 Dec 2012
- Last updated
- 3 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Study to Assess the Utility of a New Innovative Technique Using Intravenous Bicarbonate to Verify the Correct Position of Patients Scheduled for Intravenous Bicarbonate
- ClinicalTrials.gov ID
- NCT01748097
- Acronym / sponsor ID
- IVBICONCOL / IV BIC for IVONCOL
- Keywords
- infiltration, extravasation, sodium bicarbonate, capnography, end tidal carbon dioxide, chemotherapy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Collaborators
- Netherlands: Ministry of Health, Welfare and Sports
- Study start
- Dec 2012
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 12 Dec 2012 (estimated)
- 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 investigators use bicarbonate injected to an intravenous line and the changes in the exhaled end-tidal carbon dioxide to verify whether the IV line is in the vein or surrounding tissue
Detailed description
The method was proved useful in previous phase I, II studies. Now the investigators move on to assess the method in a phase III study in oncological patients.
each patients which will be subjected to intravenous chemotherapy will be eligible ( see also inclusion/exclusion criteria).
Once consent obtained the patient will have an IV line placed. each line placed will be categorized by the clinical team into 3 categories:
- IV in place ready to use for chemotherapy ( good blood return)
- Doubtful position ( no blood return/ little blood return bu flushes well).
- IV not in place. Study design Category 1. IV bicarbonate 4.2% 20 cc and NS 20 cc in a randomized fashion Category 2. same as above Category 3. No injections
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IV bicarbonate 4.2% 20 cc | Experimental | Drug: sodium bicarbonate 4.2%injecting 20cc 4.2% to a newly administered IV line |
| IV normal saline | Placebo comparator | –injecting 20 cc normal saline to a newly administered IV line |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- age 18-80 oncological disease requires intravenous chemotherapy
Key exclusion criteria (1 listed)
- 1. refusal to participate 2. lung disease acute or chronic sPo2 < 92%, PaCO2 > 50 3. renal failure Creatinine > 2 mg% 4. metabolic alkalosis HCO3 > 30 meq/L 5. medication that affect bicarbonate levels: Bicarbonate, Diamox, Fusid 6. obesity BMI > 38 7. congestive heart failure EF < 40 % or clinical signs of congestive heart failure
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 |
|---|---|---|
| sodium bicarbonate 4.2% | Drug | IV bicarbonate 4.2% 20 cc |
Primary outcome
change in exhaled end tidal co2
Time frame: 1-3 minutes
the injection of bicarbonate in a vein cause a rapid and distinct change in exhaled end-tidal CO2
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2013.
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing sodium bicarbonate 4.2% in people with Detection of the Correct Position of Intravenous Line, run by Sheba Medical Center at 2 sites in Israel.
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 1 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: status not confirmed, as of the sponsor's last update on 3 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ilan keidan, MD (97235302754, ilan.keidan@sheba.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in exhaled end tidal co2 (time frame: 1-3 minutes). 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 3 Jan 2013.