Who is sponsoring NCT01458873?

NCT01458873 is sponsored by Sheba Medical Center.

What condition does NCT01458873 study?

NCT01458873 studies Infiltration, Extravasation.

What drugs are being tested in NCT01458873?

Interventions: sodium bicarbonate 4.2%, diluted sodium bicarbonate 2.1%, normal saline.

What is the status of NCT01458873?

NCT01458873 is currently UNKNOWN.

Last reviewed 2011-10-30 · How we verify

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

NCT01458873 Phase 2/Phase 3 UNKNOWN

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.

Details

Lead sponsor	Sheba Medical Center
Phase	Phase 2/Phase 3
Status	UNKNOWN
Enrolment	20
Start date	2011-10
Completion	2012-12

Conditions

Infiltration
Extravasation

Interventions

sodium bicarbonate 4.2%
diluted sodium bicarbonate 2.1%
normal saline

Primary outcomes

transient increase in end tidal carbon dioxide — 4-12 seconds
Once sodium bicarbonate is injected the measured end-tidal carbon dioxide will transiently increase by at least 10% of baseline

Countries

Israel