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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2013-12-31

Brief Summary

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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

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Detailed Description

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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

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Detection of the Correct Position of Intravenous Line

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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IV bicarbonate 4.2% 20 cc

injecting 20cc 4.2% to a newly administered IV line

Group Type EXPERIMENTAL

sodium bicarbonate 4.2%

Intervention Type DRUG

IV normal saline

injecting 20 cc normal saline to a newly administered IV line

Group Type PLACEBO_COMPARATOR

No interventions assigned to this group

Interventions

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sodium bicarbonate 4.2%

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No