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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2012 by Dr. Ilan Keidan, Sheba Medical Center.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01748097
First Posted: December 12, 2012
Last Update Posted: January 3, 2013
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.
Collaborator:
Netherlands: Ministry of Health, Welfare and Sports
Information provided by (Responsible Party):
Dr. Ilan Keidan, Sheba Medical Center
  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
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

Resource links provided by NLM:


Further study details as provided by Dr. Ilan Keidan, Sheba Medical Center:

Primary Outcome Measures:
  • 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


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:

  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
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: December 10, 2012
First Posted: December 12, 2012
Last Update Posted: January 3, 2013
Last Verified: December 2012

Keywords provided by Dr. Ilan Keidan, Sheba Medical Center:
infiltration
extravasation
sodium bicarbonate
capnography
end tidal carbon dioxide
chemotherapy


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