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

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

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

Study Overview

• Status: Unknown
• Conditions: Detection of the Correct Position of Intravenous Line
• Intervention / Treatment: Drug: sodium bicarbonate 4.2%

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

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in exhaled end tidal co2	the injection of bicarbonate in a vein cause a rapid and distinct change in exhaled end-tidal CO2	1-3 minutes

Collaborators and Investigators

• Sponsor: Sheba Medical Center
• Collaborators: Netherlands: Ministry of Health, Welfare and Sports

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (Anticipated): December 1, 2013
• Study Completion (Anticipated): December 1, 2013

Study Registration Dates

• First Submitted: December 10, 2012
• First Submitted That Met QC Criteria: December 11, 2012
• First Posted (Estimate): December 12, 2012

Study Record Updates

• Last Update Posted (Estimate): January 3, 2013
• Last Update Submitted That Met QC Criteria: December 30, 2012
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Keywords: chemotherapy; capnography; sodium bicarbonate; infiltration; extravasation; end tidal carbon dioxide
• Other Study ID Numbers: IV BIC for IVONCOL