Investigation of the role of infusate properties related to midline catheter failure in an ovine model

Author:

Ryder Marcia1,Gunther Robert A2,Nishikawa Reid A3,Stranz Marc4,Meyer Britt M56,Spangler Taylor A7,Parker Albert E8,Sylvia Charles9

Affiliation:

1. Ryder Science Inc., Brentwood, TN

2. University of California, Davis, Davis, CA

3. Nutrishare, Inc., Elk Grove, CA

4. StranzCrossley Inc, Weston, FL

5. Duke University Hospital, Durham, NC

6. East Carolina University School of Nursing, Greenville, NC

7. VDx Veterinary Diagnostics and Preclinical Research Services, Davis, CA

8. Center for Biofilm Engineering, Department of Mathematical Sciences, Montana State University, Bozeman, MT

9. Covance Laboratories, Inc., Princeton, NJ

Abstract

Abstract Purpose Infusate osmolarity, pH, and cytotoxicity were investigated as risk factors for midline catheter failure. Methods An experimental, randomized, controlled, blinded trial was conducted using an ovine model. Two 10-cm, 18-gauge single-lumen midline catheters were inserted into the cephalic veins of sheep. The animals were divided into 6 study arms and were administered solutions of vancomycin 4 mg/mL (a low-cytotoxicity infusate) or 10 mg/mL (a high-cytotoxicity infusate), doxycycline 1 mg/mL (an acidic infusate), or acyclovir 3.5 mg/mL (an alkaline infusate) and 0.9% sodium chloride injection; or 1 of 2 premixed Clinimix (amino acids in dextrose; Baxter International) products with respective osmolarities of 675 mOsm/L (a low-osmolarity infusate) and 930 mOsm/L (a mid-osmolarity infusate). Contralateral legs were infused with 0.9% sodium chloride injection for control purposes. Catheter failure was evaluated by assessment of adverse clinical symptoms (swelling, pain, leakage, and occlusion). A quantitative vessel injury score (VIS) was calculated by grading 4 histopathological features: inflammation, mural thrombus, necrosis, and perivascular reaction. Results Among 20 sheep included in the study, the overall catheter failure rate was 95% for test catheters (median time to failure, 7.5 days; range, 3–14 days), while 60% of the control catheters failed before or concurrently (median time to failure, 7 days; range, 4.5–14 days). Four of the 6 study arms (all but the Clinimix 675-mOsm/L and acyclovir 3.5-mg/mL arms) demonstrated an increase in mean VIS of ≥77% in test vs control legs (P ≤ 0.034). Both pain and swelling occurred at higher rates in test vs control legs: 65% vs 10% and 70% vs 50%, respectively. The mean difference in rates of occlusive pericatheter mural thrombus between the test and control arms was statistically significant for the vancomycin 10-mg/mL (P = 0.0476), Clinimix 930-mOsm/L (P = 0.0406), and doxycycline 1-mg/mL (P = 0.032) arms. Conclusion Administration of infusates of varied pH, osmolarity, and cytotoxicity via midline catheter resulted in severe vascular injury and premature catheter failure; therefore, the tested infusates should not be infused via midline catheters.

Publisher

Oxford University Press (OUP)

Subject

Health Policy,Pharmacology

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