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IV iron administration in a peritoneal dialysis clinic.

Q: How can we safely and effectively administer intravenous iron to our peritoneal dialysis (PD) patients on recombinant human erythropoietin (rHuEPO) therapy to achieve and maintain adequate transferrin saturation (TSAT) and ferritin levels for erythropoiesis?

A: One of the advantages of PD is that patients spend less time in a clinic setting. Keeping that in mind, our objective was to develop a protocol for intravenous (IV) iron administration that was safe, effective, and less intrusive to our patients' lifestyle. Gastrointestinal (GI) changes seen in patients with end stage renal disease (ESRD) lead to decreased absorption of oral iron supplements (Lancaster, 2001). In addition to poor absorption, there are issues of patient compliance and GI side effects. Nausea and constipation are the most common GI side effects. Poor iron absorption coupled with decreased red blood cell production (Lancaster, 2001) leads to iron deficiency anemia in the majority of our patients. We need to be cognizant of these facts through the continuum of caring for the patient with ESRD.

The treatment for iron deficiency anemia has been oral or IV iron preparations and rHuEPO for many years. This treatment for anemia in our PD population is no exception. To improve patient outcomes, we have incorporated the DOQI evidence-based guidelines and strive for TSAT > 20%, serum ferritin levels > 100 ng/ml, and Hgb levels of 11-12 gm/dl for those on rHuEPO therapy (National Kidney Foundation [NKF], 1997).

In April 2002, our Medical Director reviewed the current protocol for anemia management and decided to change the unit IV iron administration to Venofer[R] (iron sucrose), which is an injectable iron preparation used to treat iron deficiency anemia (Venofer Package Insert, 2003). After reviewing the literature, we had a few questions.

Some of the questions we pondered were:

1. Should a test dose be given?

2. What is the ideal dose of Venofer to achieve and maintain TSAT > 20%/<500% and ferritin > 100 ng/ml/< 800 ng/ml?

3. How will we dose for maintenance iron, IV or oral, when iron is repleted (TSAT > 20% and ferritin > 100 ng/ml) (Dittrich, Schillinger, Sunder-Plassmann, & Horl, 2002)?

4. When should IV iron be held?

5. How often should iron stores be monitored?

After assessing the patients on rHuEPO therapy for absolute (ferritin < 100 ng/ml) or functional (ferritin >100 ng/ml, TSAT<20%) iron deficiency (Dittrich et al., 2002), we initiated the IV Venofer protocol.

An informed consent was obtained that stated the risks and benefits of Venofer. After pre-assessments, patients were given Venofer 200 mg in 150 cc 0.9% sodium chloride solution, to infuse over 1 hour with close monitoring. Post infusion assessments were done to ascertain any adverse reactions. If there were no reactions to the first dose, we repeated the same dose every other week x 5 doses for a total of one gram. The subsequent doses were given over 30-45 minutes with the same monitoring and assessments. Iron stores were repeated after the 5th dose was administered. Once repletion was established, patients were maintained on oral iron, if tolerated, or given Venofer 200 mg IV in 150 cc of 0.9% sodium chloride once a month.

Maintaining iron repletion is very important in managing anemia. Therefore, iron levels were monitored on a monthly basis if patients were on a maintenance IV iron dose. Iron levels were monitored quarterly if they were taking oral iron supplements. Evaluating iron levels at these intervals alerted us early to levels trending toward iron overload or levels needing a different dose schedule. TSAT > 50% and ferritin > 800 ng/ml were the parameters we used to hold iron therapy. When iron therapy was on hold, we continued to monitor iron stores monthly. The time to restart iron therapy was as important as the time to hold.

In evaluating this Venofer protocol for safety, we noted no adverse effects from its use. Since the literature reports anaphylactoid reactions to Venofer (Venofer Package Insert, 2003), we had medications and equipment available to treat patients if such reactions occurred.

In addition, none of our patients complained about the schedule and were compliant with clinic appointments. Hence, we concluded that our protocol was safe and minimally intrusive.

In conclusion, our team looked at pre and post Venofer TSAT, serum ferritin, calculated hematocrit (chct), and rHuEPO doses on all patients monthly to determine trends and effectiveness of our protocol. After using Venofer for 6 months and determining positive responses, we decided to continue.

As of February 2004, we had administered Venofer per protocol to 33 patients. One hundred percent had increases in their ferritin levels, and 97% had increases in their TSAT. Serum ferritin levels > 800 ng/ml were seen in only 12%. We also saw decreased rHuEPO doses in 40.7% of these patients 2 weeks into protocol to 8 weeks post 5th dose.

In our clinical setting, we will continue administering IV Venofer to our PD population and monitor closely for adverse reactions and efficacy. To assure optimum outcomes, the data will be analyzed to determine if different dose schedules are needed to maintain iron stores and to prevent elevations in serum ferritin levels. We will continue to use the data gathered and make changes as necessary.

References

Dittrich, S., Schillinger, M., Sunder-Plassmann, G.,& Horl, W.H. (2002). Efficacy of a low dose intravenous iron sucrose regimen in peritoneal dialysis patients. Peritoneal Dialysis International, 22, 60-66.

Lancaster, L.E., (2001). Systemic manifestations of renal disease. In L.E. Lancaster (Ed.), Core curriculum for nephrology nursing (3rd ed.) (pp. 140-142). Pitman, NJ: American Nephrology Nurses' Association.

National Kidney Foundation (NKF). (1997). DOQI clinical practice guidelines for the treatment of anemia of chronic renal failure (p. 30). New York: Author.

Venofer[R] Package Insert. (2003). Shirley, NY: American Regent Laboratories, Inc.

Acknowledgment: The author wishes to acknowledge the support and data monitoring assistance from Dr. Christina Ynares; Cheryl Conquest, RN; Tina O'Connor, PLN; and Kay Lister, RN; and the invaluable feedback from SFC Gary L. Bush II and Suzanne Kelso in preparation of this article.

Barbara Bush, RN, BSN, CNN, is Staff Nurse, Peritoneal Dialysis Center, Middle Tennessee/Dialysis Clinic, Inc., Nashville, TN. She is a member of ANNA's Music City Chapter.
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Title Annotation:Clinical Consult
Author:Bush, Barbara (American first lady)
Publication:Nephrology Nursing Journal
Geographic Code:1USA
Date:Jul 1, 2004
Words:1030
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