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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by Sheba Medical Center.
Recruitment status was  Recruiting
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

October 9, 2011
October 30, 2011
October 2011
December 2012   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01458873 on ClinicalTrials.gov Archive Site
  • 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
  • Change in blood pH and electrolytes [ Time Frame: 10-20 minutes ] [ Designated as safety issue: Yes ]
    Blood pH and electrolytes 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
Not Provided
Not Provided
 
Intravenous Sodium Bicarbonate Verifies Intravenous Position of Catheters in Spontaneously Breathing Adult Volunteers
Intravenous Sodium Bicarbonate Verifies Intravenous Position of Catheters in Spontaneously Breathing Adult Volunteers

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.

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.

Interventional
Phase 2
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Diagnostic
  • Infiltration
  • Extravasation
  • Drug: sodium bicarbonate 4.2%
    diluted sodium bicarbonate 50 ml
    Other Name: sodium bicarbonate 4.2%
  • Drug: diluted sodium bicarbonate 2.1%
    50ml
    Other Name: sodium bicarbonate 2.1%
  • Drug: normal saline
    50ml
    Other Name: normal saline
  • Experimental: sodium bicarbonate 4.2%
    sodium bicarbonate 4.2% 50 m"l
    Intervention: Drug: sodium bicarbonate 4.2%
  • Experimental: sodium bicarbonate 2.1%
    sodium bicarbonate 2.1% 1 50 m"l
    Intervention: Drug: diluted sodium bicarbonate 2.1%
  • Placebo Comparator: normal saline
    50 m"l normal saline
    Intervention: Drug: normal saline
Keidan I, Ben-Menachem E, Barzilai A, Nur I, Berkenstadt H. Intravenous sodium bicarbonate verifies intravenous position of catheters in ventilated patients. Anesth Analg. 2011 Aug;113(2):279-81. doi: 10.1213/ANE.0b013e3182222ed0. Epub 2011 Jun 3.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
December 2012
December 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • ASA I,II
  • no cardiovascular or respiratory disease

Exclusion Criteria:

  • ASA > II
  • Cardiovascular disease
  • Respiratory disease
  • renal failure
  • metabolic alkalosis
Both
18 Years to 50 Years
Yes
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
Israel
 
NCT01458873
SHEBA-11-8716-IK-CTIL
No
Dr. Ilan Keidan, Sheba Medical Center
Sheba Medical Center
Not Provided
Not Provided
Sheba Medical Center
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP