Intravenous Bicarbonate To Verify The Correct Position of IV Catheters in Oncological Patients Oncological Patients Receiving Chemotherapy (IVBICONCOL)
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|ClinicalTrials.gov 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
|Condition or disease||Intervention/treatment||Phase|
|Detection of the Correct Position of Intravenous Line||Drug: sodium bicarbonate 4.2%||Phase 2 Phase 3|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
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
- 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
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
|Contact: ilan keidan, MDfirstname.lastname@example.org|
|Oncology Clinic||Not yet recruiting|
|Tel Hashomer, Israel, 52621|
|Contact: ilan keidan, MD 972526669370 email@example.com|
|Sheba Medical Center Oncology||Recruiting|
|Tel Hashomer, Israel, 52621|
|Contact: ilan keidan, MD 07235302754 firstname.lastname@example.org|