A Phase 2/3 interventional study of sodium bicarbonate 4.2% and diluted sodium bicarbonate 2.1% in Infiltration and Extravasation, sponsored by Sheba Medical Center. Status unknown at 1 site in Israel. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-11-01.
Sponsored by Sheba Medical Center · Phase 2/3, Interventional, and Diagnostic
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.
Sheba Medical Center is the lead sponsor of 660 studies on the registry; 63 are open to participants now.
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Exclusion Criteria:
sodium bicarbonate 4.2% 50 m"l
Drug: sodium bicarbonate 4.2%
sodium bicarbonate 2.1% 1 50 m"l
Drug: diluted sodium bicarbonate 2.1%
50 m"l normal saline
Drug: normal saline
diluted sodium bicarbonate 50 ml
50ml
Also known as: sodium bicarbonate 2.1%
50ml
transient increase in end tidal carbon dioxide
Once sodium bicarbonate is injected the measured end-tidal carbon dioxide will transiently increase by at least 10% of baseline
Time frame: 4-12 seconds
Change in venous blood pH
Blood pH and will be measured prior and ten minutes after the injections
Time frame: 10-20 minutes
Subjective adverse symptoms associated with injection of sodium bicarbonate
The subjective symptoms as well as hemodynamic changes associated with the injection of sodium bicarbonate will be recorded
Time frame: 1 minute
change in venous blood sodium
blood sodium level will be measured before and 10-20 minutes after the end of the injections.
Time frame: 10- 20 minutes
change in venous blood bicarbonate level
blood level of bicarbonate will be measured before and 10-20 minutes after the injection.
Time frame: 10-20 minutes
change in venous blood potasium level
venous blood potasium level will be measured before and 10-20 minutes after injection
Time frame: 10-20 minutes
This study is status unknown, as verified in Oct 2011. You cannot join it, but the record below documents what was studied.
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Sheba Medical Center