drugset / Trial / NCT01458873

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

NCT01458873

Phase 2/3 Unknown 20 enrolled Sheba Medical Center
Non-randomizedCrossoverTriple-blindDiagnostic

Summary

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.

Timeline

Start
2011-10
Primary completion
2012-12
Completion
2012-12

Drugs

EvaluationDrugModalityDoseRoute
Subject sodium bicarbonate Diagnostic / imaging agent 2.1 % Intravenous
Subject sodium bicarbonate Diagnostic / imaging agent 4.2 % Intravenous
Subject sodium bicarbonate Diagnostic / imaging agent 50 ml Intravenous

Indications

No indication recorded.