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

Sheba Medical Center

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Detection of the Correct Position of Intravenous Line

Treatments: Drug: sodium bicarbonate 4.2%

Study type: Interventional

Funder types: Other

Identifiers

NCT01748097

IV BIC for IVONCOL

Details and patient eligibility

About

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

Full 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

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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100 participants in 2 patient groups, including a placebo group

IV bicarbonate 4.2% 20 cc

Experimental group

Description:

injecting 20cc 4.2% to a newly administered IV line

Treatment:

Drug: sodium bicarbonate 4.2%

IV normal saline

Placebo Comparator group

Description:

injecting 20 cc normal saline to a newly administered IV line