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Intravenous Sodium Bicarbonate Verifies Intravenous Position of Catheters in Spontaneously Breathing Adult Volunteers

This study is currently recruiting participants.
Verified October 2011 by Sheba Medical Center
Sponsor:
Information provided by (Responsible Party):
Dr. Ilan Keidan, Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT01458873
First received: October 9, 2011
Last updated: October 30, 2011
Last verified: October 2011
History of Changes
  Purpose

Vascular access in patients carries a significant risk of accidental extravasation of intravenous (IV) fluids and medications with the potential for tissue injury. This prospective controlled study assessed the diagnostic utility of using intravenous diluted sodium bicarbonate to confirm placement of IV catheters in volunteers . Diluted sodium bicarbonate or 0.9% normal saline, will be injected in a randomized order while end-tidal carbon dioxide in the exhaled air will be monitored. The investigators hypothesize that the injected bicarbonate will dissolve into carbon dioxide and water and cause a transient increase in the measured exhaled CO2.

The effect is unique to bicarbonate and will not appear once normal saline is injected. the safety of the administration of bicarbonate on the metabolic profile of the volunteers will be assessed by measurement of venous blood pH and electrolytes.


Condition Intervention Phase
Infiltration
Extravasation
 Drug: sodium bicarbonate 4.2%
Drug: diluted sodium bicarbonate 2.1%
Drug: normal saline
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Intravenous Sodium Bicarbonate Verifies Intravenous Position of Catheters in Spontaneously Breathing Adult Volunteers

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • transient increase in end tidal carbon dioxide [ Time Frame: 4-12 seconds ] [ Designated as safety issue: Yes ]
    Once sodium bicarbonate is injected the measured end-tidal carbon dioxide will transiently increase by at least 10% of baseline


Secondary Outcome Measures:
  • Change in venous blood pH [ Time Frame: 10-20 minutes ] [ Designated as safety issue: Yes ]
    Blood pH and will be measured prior and ten minutes after the injections

  • Subjective adverse symptoms associated with injection of sodium bicarbonate [ Time Frame: 1 minute ] [ Designated as safety issue: Yes ]
    The subjective symptoms as well as hemodynamic changes associated with the injection of sodium bicarbonate will be recorded

  • change in venous blood sodium [ Time Frame: 10- 20 minutes ] [ Designated as safety issue: Yes ]
    blood sodium level will be measured before and 10-20 minutes after the end of the injections.

  • change in venous blood bicarbonate level [ Time Frame: 10-20 minutes ] [ Designated as safety issue: Yes ]
    blood level of bicarbonate will be measured before and 10-20 minutes after the injection.

  • change in venous blood potasium level [ Time Frame: 10-20 minutes ] [ Designated as safety issue: Yes ]
    venous blood potasium level will be measured before and 10-20 minutes after injection


Estimated Enrollment: 20
Study Start Date: October 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: sodium bicarbonate 4.2%
sodium bicarbonate 4.2% 50 m"l
 Drug: sodium bicarbonate 4.2%
diluted sodium bicarbonate 50 ml
Other Name: sodium bicarbonate 4.2%
Experimental: sodium bicarbonate 2.1%
sodium bicarbonate 2.1% 1 50 m"l
 Drug: diluted sodium bicarbonate 2.1%
50ml
Other Name: sodium bicarbonate 2.1%
Placebo Comparator: normal saline
50 m"l normal saline
 Drug: normal saline
50ml
Other Name: normal saline

Detailed Description:

Vascular access in patients carries a significant risk of accidental extravasation of intravenous (IV) fluids and medications with the potential for tissue injury. This prospective controlled study assessed the diagnostic utility of using intravenous diluted sodium bicarbonate to confirm placement of IV catheters in volunteers . Diluted sodium bicarbonate or 0.9% normal saline, will be injected in a randomized order while end-tidal carbon dioxide in the exhaled air will be monitored. The investigators hypothesize that the injected bicarbonate will dissolve into carbon dioxide and water and cause a transient increase in the measured exhaled CO2. Arbitrary increase of more than 10%in end-tidal carbon dioxide is considered as a positive response.

The effect is unique to bicarbonate and will not appear once normal saline is injected. the safety of the administration of bicarbonate on the metabolic profile of the volunteers will be assessed by measurement of venous blood pH and electrolytes.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • ASA I,II
  • no cardiovascular or respiratory disease

Exclusion Criteria:

  • ASA > II
  • Cardiovascular disease
  • Respiratory disease
  • renal failure
  • metabolic alkalosis
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01458873

Contacts
Contact: ILAN KEIDAN, MD 972-3-5302754 ilan.keidan@sheba.health.gov.il
Contact: Ilan keidan, MD 972-3-5302754 ilan.keidan@sheba.health.gov.il

Locations
Israel
Sheba Medical Center Recruiting
Tel Hashomer, Israel, 52621
Contact: ilan keidan, MD     972-3-530-2754     ilan.keidan@sheba.health.gov.il    
Sponsors and Collaborators
Sheba Medical Center
  More Information

Publications:

Responsible Party: Dr. Ilan Keidan, Director, Pediatric Anesthesia, Sheba Medical center, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT01458873     History of Changes
Other Study ID Numbers: SHEBA-11-8716-IK-CTIL
Study First Received: October 9, 2011
Last Updated: October 30, 2011
Health Authority: Israel: Ministry of Health

Keywords provided by Sheba Medical Center:
infiltration
extravasation

ClinicalTrials.gov processed this record on June 17, 2013