NCT01748097

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

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

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Sheba Medical Center · Other Government
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Conditions

• Detection of the Correct Position of Intravenous Line

Interventions

Type	Name	Description
DRUG	sodium bicarbonate 4.2%

Timeline

• Start date: 2012-12-01
• Primary completion: 2013-12-01
• Completion: 2013-12-01
• First posted: 2012-12-12
• Last updated: 2013-01-03

Locations

2 sites across 1 country: Israel