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

Detection of the Correct Position of Intravenous Line Clinical Trial

— IVBICONCOL  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01748097
• Other study ID #: IV BIC for IVONCOL
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: December 10, 2012
• Last updated: December 30, 2012
• Start date: December 2012
• Est. completion date: December 2013

Study information

• Verified date: December 2012
• Source: Sheba Medical Center
• Contact: ilan keidan, MD
• Phone: 97235302754
• Email: ilan.keidan[@]sheba.health.gov.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Detection of the Correct Position of Intravenous Line

Intervention

Drug:
• sodium bicarbonate 4.2%

Locations

Country	Name	City	State
Israel	Oncology Clinic	Tel Hashomer
Israel	Sheba Medical Center Oncology	Tel Hashomer

Sponsors (2)

Lead Sponsor	Collaborator
Sheba Medical Center	Netherlands: Ministry of Health, Welfare and Sports

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes