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

Phase 2

• Conditions: Detection of the Correct Position of Intravenous Line
• Interventions: Drug: sodium bicarbonate 4.2%

• Registration Number: NCT01748097
• Lead Sponsor: 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

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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2012-12
• Study Start: 2012-12
• Study First Submitted: 2012-12-10
• Study First Submitted QC: 2012-12-11
• Study First Posted: 2012-12-12
• Last Update Submitted: 2012-12-30
• Last Update Posted: 2013-01-03
• Primary Completion: 2013-12
• Study Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• age 18-80 oncological disease requires intravenous chemotherapy

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
IV bicarbonate 4.2% 20 cc	sodium bicarbonate 4.2%	injecting 20cc 4.2% to a newly administered IV line

Primary Outcome Measures

Name	Time	Method
change in exhaled end tidal co2	1-3 minutes	the injection of bicarbonate in a vein cause a rapid and distinct change in exhaled end-tidal CO2

Trial Locations

Locations (2)

Sheba Medical Center Oncology; 🇮🇱 Tel Hashomer, Israel

Oncology Clinic; 🇮🇱 Tel Hashomer, Israel