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Particulate matter assessment of a clinical investigation on filtration and infusion phlebitis
Abstract:
Particulate contamination levels of a base intravenous solution and five admixtures were assessed in a double-blind study conducted to determine the effect of inline i.v. filtration on infusion phlebitis. Only a qualitative evaluation on actual patient filters was possible due to deformation of the filter membrane after 72 hours; simulation of i.v. therapy in the laboratory gave more reliable information about particle counts and distribution. The base solution was dextrose 5% in 0.2% sodium chloride injection; the admixtures contained this base solution and the following additives (per liter): (1) 20 mEq potassium chloride, (2) 20 mEq potassium chloride and 2 ml vitamin B complex, (3) 20 mEq potassium chloride and 5 million units of potassium penicillin G, (4) 20 mEq potassium chloride and 1 g cephalothin sodium (delivered in a 100-ml volume from a medication chamber), and (5) 30 mEq potassium chloride and 3 million units of penicillin G (delivered every four hours from a medication chamber) and 80 mg of gentamicin sulfate (delivered every eight hours from a medication chamber). None of the six i.v. infusion schedules simulated exceeded the standards for particulate matter prescribed by the USP XIX. As expected, however, the particle counts increased as a function of the additives used in the simulation, particularly with the antibiotics.
Insights
Particulate contamination in intravenous (IV) solutions increased with additives, especially antibiotics. Laboratory simulations showed particle counts rose with added components, but all tested IV infusion schedules remained within United States Pharmacopeia (USP) standards.
Area of Science:
- Pharmaceutical Science
- Medical Technology
- Clinical Pharmacy
Background:
- Particulate contamination in intravenous (IV) solutions is a concern for patient safety.
- Inline IV filtration is used to reduce particulate load during infusions.
- Infusion phlebitis can be associated with particulate matter in IV fluids.
Purpose of the Study:
- To assess particulate contamination levels in a base IV solution and five admixtures.
- To determine the effect of inline IV filtration on infusion phlebitis.
- To evaluate particle counts and distribution in simulated IV therapy.
Main Methods:
- A double-blind study was conducted.
- Particulate contamination was assessed in a base dextrose 5% in 0.2% sodium chloride injection and five admixtures.
- Laboratory simulations of IV therapy were used to evaluate particle counts and distribution.
- Actual patient filters were qualitatively evaluated due to membrane deformation after 72 hours.
Main Results:
- None of the six simulated IV infusion schedules exceeded the particulate matter standards set by USP XIX.
- Particle counts increased with the addition of components to the base IV solution.
- Antibiotic additives, specifically penicillin G and cephalothin sodium, significantly increased particle counts.
Conclusions:
- Simulated IV therapy particle counts increase with additives, particularly antibiotics.
- While particle counts rise with additives, tested IV infusion schedules met USP standards.
- Laboratory simulations provide reliable data on particle counts and distribution in IV admixtures.