InfiltrationPhase 2/3NCT01458873
Intravenous Sodium Bicarbonate Verifies Intravenous Position of Catheters in Spontaneously Breathing Adult Volunteers
A Phase 2/3 study testing sodium bicarbonate 4.2%, diluted sodium bicarbonate 2.1% and normal saline in people with Infiltration and Extravasation, run by Sheba Medical Center at 1 site in Israel.
Trial summary
Vascular access in patients carries a significant risk of accidental extravasation of intravenous (IV) fluids and medications with the potential for tissue injury. This prospective controlled study assessed the diagnostic utility of using intravenous diluted sodium bicarbonate to confirm placement of IV catheters in… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Infiltration, Extravasation
- What is being tested?
- sodium bicarbonate 4.2%, diluted sodium bicarbonate 2.1% and normal saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteIsrael
- Study dates
- Oct 2011to Dec 2012
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- ASA I,II
- no cardiovascular or respiratory disease
Who cannot join
- ASA > II
- Cardiovascular disease
- Respiratory disease
- renal failure
- metabolic alkalosis
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Sheba Medical Center
Tel HaShomer, 52621
ilan keidan, MD, 972-3-530-2754, ilan.keidan@sheba.health.gov.il
About this study
Vascular access in patients carries a significant risk of accidental extravasation of intravenous (IV) fluids and medications with the potential for tissue injury. This prospective controlled study assessed the diagnostic utility of using intravenous diluted sodium bicarbonate to confirm placement of IV catheters in volunteers . Diluted sodium bicarbonate or 0.9% normal saline, will be injected in a randomized order while end-tidal carbon dioxide in the exhaled air will be monitored. The investigators hypothesize that the injected bicarbonate will dissolve into carbon dioxide and water and cause a transient increase in the measured exhaled CO2.
The effect is unique to bicarbonate and will not appear once normal saline is injected. the safety of the administration of bicarbonate on the metabolic profile of the volunteers will be assessed by measurement of venous blood pH and electrolytes.
Read the detailed description
Vascular access in patients carries a significant risk of accidental extravasation of intravenous (IV) fluids and medications with the potential for tissue injury. This prospective controlled study assessed the diagnostic utility of using intravenous diluted sodium bicarbonate to confirm placement of IV catheters in volunteers . Diluted sodium bicarbonate or 0.9% normal saline, will be injected in a randomized order while end-tidal carbon dioxide in the exhaled air will be monitored. The investigators hypothesize that the injected bicarbonate will dissolve into carbon dioxide and water and cause a transient increase in the measured exhaled CO2. Arbitrary increase of more than 10%in end-tidal carbon dioxide is considered as a positive response.
The effect is unique to bicarbonate and will not appear once normal saline is injected. the safety of the administration of bicarbonate on the metabolic profile of the volunteers will be assessed by measurement of venous blood pH and electrolytes.
- Conditions
- Infiltration, Extravasation
- Being tested
- sodium bicarbonate 4.2%, diluted sodium bicarbonate 2.1%, normal saline
- Keywords
- infiltration, extravasation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sodium bicarbonate 4.2%Drug
diluted sodium bicarbonate 50 ml
diluted sodium bicarbonate 2.1%Drug
Also called sodium bicarbonate 2.1%
50ml
normal salineDrug
50ml
| Study group | Role | What they receive |
|---|---|---|
| sodium bicarbonate 4.2% | Experimental | sodium bicarbonate 4.2% 50 m"l Receives: Drug: sodium bicarbonate 4.2% |
| sodium bicarbonate 2.1% | Experimental | sodium bicarbonate 2.1% 1 50 m"l Receives: Drug: diluted sodium bicarbonate 2.1% |
| normal saline | Placebo comparator | 50 m"l normal saline Receives: Drug: normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
transient increase in end tidal carbon dioxide
Once sodium bicarbonate is injected the measured end-tidal carbon dioxide will transiently increase by at least 10% of baseline
Measured: 4-12 seconds
Secondary outcomes (5)
Change in venous blood pH
Blood pH and will be measured prior and ten minutes after the injections
Measured: 10-20 minutes
Subjective adverse symptoms associated with injection of sodium bicarbonate
The subjective symptoms as well as hemodynamic changes associated with the injection of sodium bicarbonate will be recorded
Measured: 1 minute
change in venous blood sodium
blood sodium level will be measured before and 10-20 minutes after the end of the injections.
Measured: 10- 20 minutes
change in venous blood bicarbonate level
blood level of bicarbonate will be measured before and 10-20 minutes after the injection.
Measured: 10-20 minutes
change in venous blood potasium level
venous blood potasium level will be measured before and 10-20 minutes after injection
Measured: 10-20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2011 (estimated)
- Study startOct 2011
- Primary completionDec 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for InfiltrationStudies 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
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. Ilan Keidan, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01458873
- Sponsor's protocol ID
- SHEBA-11-8716-IK-CTIL
- Status last verified
- Oct 2011
- First submitted
- 9 Oct 2011
- Last updated
- 1 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Keidan I, Ben-Menachem E, Barzilai A, Nur I, Berkenstadt H. Intravenous sodium bicarbonate verifies intravenous position of catheters in ventilated patients. Anesth Analg. 2011 Aug;113(2):279-81. doi: 10.1213/ANE.0b013e3182222ed0. Epub 2011 Jun 3.
PubMed 21642603Keidan I, Sidi A, Ben-Menachem E, Derazne E, Berkenstadt H. A simple diagnostic test to confirm correct intravascular placement of peripheral catheters in order to avoid extravasation. J Clin Anesth. 2015 Nov;27(7):585-8. doi: 10.1016/j.jclinane.2015.07.004. Epub 2015 Aug 15.
PubMed 26286133
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous Sodium Bicarbonate Verifies Intravenous Position of Catheters in Spontaneously Breathing Adult Volunteers
- ClinicalTrials.gov ID
- NCT01458873
- Acronym / sponsor ID
- SHEBA-11-8716-IK-CTIL
- Conditions
- Infiltration, Extravasation
- Keywords
- infiltration, extravasation
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Oct 2011
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 25 Oct 2011 (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.
Vascular access in patients carries a significant risk of accidental extravasation of intravenous (IV) fluids and medications with the potential for tissue injury. This prospective controlled study assessed the diagnostic utility of using intravenous diluted sodium bicarbonate to confirm placement of IV catheters in volunteers . Diluted sodium bicarbonate or 0.9% normal saline, will be injected in a randomized order while end-tidal carbon dioxide in the exhaled air will be monitored. The investigators hypothesize that the injected bicarbonate will dissolve into carbon dioxide and water and cause a transient increase in the measured exhaled CO2.
The effect is unique to bicarbonate and will not appear once normal saline is injected. the safety of the administration of bicarbonate on the metabolic profile of the volunteers will be assessed by measurement of venous blood pH and electrolytes.
Detailed description
Vascular access in patients carries a significant risk of accidental extravasation of intravenous (IV) fluids and medications with the potential for tissue injury. This prospective controlled study assessed the diagnostic utility of using intravenous diluted sodium bicarbonate to confirm placement of IV catheters in volunteers . Diluted sodium bicarbonate or 0.9% normal saline, will be injected in a randomized order while end-tidal carbon dioxide in the exhaled air will be monitored. The investigators hypothesize that the injected bicarbonate will dissolve into carbon dioxide and water and cause a transient increase in the measured exhaled CO2. Arbitrary increase of more than 10%in end-tidal carbon dioxide is considered as a positive response.
The effect is unique to bicarbonate and will not appear once normal saline is injected. the safety of the administration of bicarbonate on the metabolic profile of the volunteers will be assessed by measurement of venous blood pH and electrolytes.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| sodium bicarbonate 4.2% | Experimental | Drug: sodium bicarbonate 4.2%sodium bicarbonate 4.2% 50 m"l |
| sodium bicarbonate 2.1% | Experimental | Drug: diluted sodium bicarbonate 2.1%sodium bicarbonate 2.1% 1 50 m"l |
| normal saline | Placebo comparator | Drug: normal saline50 m"l normal saline |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- ASA I,II
- no cardiovascular or respiratory disease
Key exclusion criteria (5 listed)
- ASA > II
- Cardiovascular disease
- Respiratory disease
- renal failure
- metabolic alkalosis
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%diluted sodium bicarbonate 50 ml | Drug | sodium bicarbonate 4.2% |
| diluted sodium bicarbonate 2.1%Also: sodium bicarbonate 2.1%50ml | Drug | sodium bicarbonate 2.1% |
| normal saline50ml | Drug | normal saline |
Primary outcome
transient increase in end tidal carbon dioxide
Time frame: 4-12 seconds
Once sodium bicarbonate is injected the measured end-tidal carbon dioxide will transiently increase by at least 10% of baseline
5 secondary outcomes
Change in venous blood pH
Time frame: 10-20 minutes
Subjective adverse symptoms associated with injection of sodium bicarbonate
Time frame: 1 minute
change in venous blood sodium
Time frame: 10- 20 minutes
change in venous blood bicarbonate level
Time frame: 10-20 minutes
change in venous blood potasium level
Time frame: 10-20 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2011.
- Background: PubMed 21642603Keidan I, Ben-Menachem E, Barzilai A, Nur I, Berkenstadt H. Intravenous sodium bicarbonate verifies intravenous position of catheters in ventilated patients. Anesth Analg. 2011 Aug;113(2):279-81. doi: 10.1213/ANE.0b013e3182222ed0. Epub 2011 Jun 3.
- Derived from this study: PubMed 26286133Keidan I, Sidi A, Ben-Menachem E, Derazne E, Berkenstadt H. A simple diagnostic test to confirm correct intravascular placement of peripheral catheters in order to avoid extravasation. J Clin Anesth. 2015 Nov;27(7):585-8. doi: 10.1016/j.jclinane.2015.07.004. Epub 2015 Aug 15.
Related trials for Infiltration
RecruitingPhase 4
Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery
Head and Neck Cancer (H&N)
RecruitingPhase 2
Multitargeted Recombinant Ad5 PSA/MUC-1/Brachyury-Based Immunotherapy (TriAdeno) Vaccine With IL-15 Superagonist N-803 in Participants With Clinically Localized Prostate Cancer Undergoing Active Surveillance
Adenocarcinoma, Prostate Cancer
RecruitingPhase 2
Immunotherapy Using Tumor Infiltrating Lymphocytes for Patients With Metastatic Cancer
Metastatic Colorectal Cancer, Metastatic Pancreatic Cancer
RecruitingPhase 1/2
Safety and Efficacy of OBX-115 in Advanced Solid Tumors
Tumor Skin, Metastatic Melanoma
RecruitingPhase 1/2
A Phase 1/2 Study of KSQ-004EX, Autologous Tumor Infiltrating Lymphocytes Engineered to Inactivate Genes Encoding SOCS1 and Regnase-1, in Patients With Select Advanced Solid Tumors
Select Advanced Solid Tumors
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.
1 site 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%, diluted sodium bicarbonate 2.1% and normal saline in people with Infiltration and Extravasation, run by Sheba Medical Center at 1 site 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 2 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: status not confirmed, as of the sponsor's last update on 1 Nov 2011. 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 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 (972-3-5302754, 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?
transient increase in end tidal carbon dioxide (time frame: 4-12 seconds). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01458873, which also lists 2 linked publications.
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 1 Nov 2011.