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Intravenous Bicarbonate To Verify The Correct Position of IV Catheters in Oncological Patients Oncological Patients Receiving Chemotherapy (IVBICONCOL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01748097
Recruitment Status : Unknown
Verified December 2012 by Dr. Ilan Keidan, Sheba Medical Center.
Recruitment status was:  Recruiting
First Posted : December 12, 2012
Last Update Posted : January 3, 2013
Netherlands: Ministry of Health, Welfare and Sports
Information provided by (Responsible Party):
Dr. Ilan Keidan, Sheba Medical Center

Brief 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

Condition or disease Intervention/treatment Phase
Detection of the Correct Position of Intravenous Line Drug: sodium bicarbonate 4.2% Phase 2 Phase 3

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:

  1. IV in place ready to use for chemotherapy ( good blood return)
  2. Doubtful position ( no blood return/ little blood return bu flushes well).
  3. 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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Diagnostic
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
Study Start Date : December 2012
Estimated Primary Completion Date : December 2013
Estimated Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: IV bicarbonate 4.2% 20 cc
injecting 20cc 4.2% to a newly administered IV line
Drug: sodium bicarbonate 4.2%
Placebo Comparator: IV normal saline
injecting 20 cc normal saline to a newly administered IV line

Primary Outcome Measures :
  1. 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • age 18-80 oncological disease requires intravenous chemotherapy

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01748097

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Contact: ilan keidan, MD 97235302754

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Oncology Clinic Not yet recruiting
Tel Hashomer, Israel, 52621
Contact: ilan keidan, MD    972526669370   
Sheba Medical Center Oncology Recruiting
Tel Hashomer, Israel, 52621
Contact: ilan keidan, MD    07235302754   
Sponsors and Collaborators
Sheba Medical Center
Netherlands: Ministry of Health, Welfare and Sports

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Responsible Party: Dr. Ilan Keidan, director pediatric anesthesia, Sheba Medical Center Identifier: NCT01748097    
Other Study ID Numbers: IV BIC for IVONCOL
First Posted: December 12, 2012    Key Record Dates
Last Update Posted: January 3, 2013
Last Verified: December 2012
Keywords provided by Dr. Ilan Keidan, Sheba Medical Center:
sodium bicarbonate
end tidal carbon dioxide