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

December 30, 2012 updated by: Dr. Ilan Keidan, Sheba Medical Center

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sheba Medical Center

Collaborators

Netherlands: Ministry of Health, Welfare and Sports

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Other Study ID Numbers

  • IV BIC for IVONCOL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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