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

This study is currently recruiting participants.

Verified December 2012 by Sheba Medical Center

Sponsor:

Collaborator:

Netherlands: Ministry of Health, Welfare and Sports

Information provided by (Responsible Party):

Dr. Ilan Keidan, Sheba Medical Center

ClinicalTrials.gov Identifier:

NCT01748097

First received: December 10, 2012

Last updated: December 30, 2012

Last verified: December 2012

History of Changes

Purpose

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	Intervention	Phase
Detection of the Correct Position of Intravenous Line	Drug: sodium bicarbonate 4.2%	Phase 2 Phase 3

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, 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

Resource links provided by NLM:

Drug Information available for: Sodium bicarbonate

U.S. FDA Resources

Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:

change in exhaled end tidal co2 [ Time Frame: 1-3 minutes ] [ Designated as safety issue: Yes ]
the injection of bicarbonate in a vein cause a rapid and distinct change in exhaled end-tidal CO2

Estimated Enrollment:	100
Study Start Date:	December 2012
Estimated Study Completion Date:	December 2013
Estimated Primary Completion Date:	December 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01748097

Contacts

Contact: ilan keidan, MD

97235302754

ilan.keidan@sheba.health.gov.il

Locations

Israel
Oncology Clinic	Not yet recruiting
Tel Hashomer, Israel, 52621
Contact: ilan keidan, MD 972526669370 ilan.keidan@sheba.health.gov.il
Sheba Medical Center Oncology	Recruiting
Tel Hashomer, Israel, 52621
Contact: ilan keidan, MD 07235302754 ilan.keidan@sheba.health.gov.il

Sponsors and Collaborators

Sheba Medical Center

Netherlands: Ministry of Health, Welfare and Sports

More Information

No publications provided

Responsible Party:	Dr. Ilan Keidan, director pediatric anesthesia, Sheba Medical Center
ClinicalTrials.gov Identifier:	NCT01748097 History of Changes
Other Study ID Numbers:	IV BIC for IVONCOL
Study First Received:	December 10, 2012
Last Updated:	December 30, 2012
Health Authority:	Israel: Ministry of Health

Keywords provided by Sheba Medical Center:

infiltration
extravasation
sodium bicarbonate

capnography
end tidal carbon dioxide
chemotherapy

ClinicalTrials.gov processed this record on May 16, 2013

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