scholarly journals Evaluation of an Oral Sodium Bicarbonate Protocol for High-Dose Methotrexate Urine Alkalinization

2021 ◽  
Author(s):  
Rachel Heisler ◽  
Jordan Kelly ◽  
Sara Abedinzadegan Abdi ◽  
Jennifer Hawker ◽  
Leanne Fong ◽  
...  
Keyword(s):  
Serum Creatinine ◽  
Sodium Bicarbonate ◽  
Retrospective Chart Review ◽  
High Dose ◽  
High Dose Methotrexate ◽  
Dose Methotrexate ◽  
Urine Alkalinization ◽  
Nausea And Emesis ◽  
Alberta Health ◽  
Oral Sodium

Abstract Purpose: Intravenous (IV) sodium bicarbonate is considered standard therapy for high-dose methotrexate (HDMTX) urine alkalinization. Due to a national IV sodium bicarbonate shortage, an oral (PO) sodium bicarbonate protocol was implemented by Alberta Health Services (AHS) for HDMTX urine alkalinization. This study aims to evaluate the efficacy and safety of the PO sodium bicarbonate protocol compared to IV sodium bicarbonate for HDMTX urine alkalinization. Methods: A retrospective chart review of adult patients who received HDMTX (>500 mg/m2) with sodium bicarbonate for urine alkalinization at 4 hospitals in Alberta was conducted. Patients who received IV sodium bicarbonate between January-June 2017 and PO sodium bicarbonate between July-December 2017 were compared for the primary outcome of time to methotrexate clearance. Results: A total of 84 and 78 HDMTX cycles were included in the IV and PO cohorts, respectively. No difference in time to methotrexate clearance was seen between the IV and PO cohorts, 91.6 (± 35.4) hours and 95.2 (± 44) hours respectively; p=0.5. The proportion of HDMTX cycles that experienced a >25% increase in serum creatinine was not statistically significant, IV protocol 12% and PO protocol 5%; p=0.13. Nausea and emesis occurred more frequently in the PO cohort than the IV cohort, though rarely resulted in refused doses or change to alternate sodium bicarbonate formulations.Conclusions: The results of this study indicate that the AHS PO sodium bicarbonate protocol was no different in time to methotrexate clearance or rates of increased serum creatinine when compared to IV sodium bicarbonate.

scholarly journals Evaluation of an oral sodium bicarbonate protocol for high-dose methotrexate urine alkalinization

2021 ◽  
Author(s):  
Rachel D. Heisler ◽  
Jordan J. Kelly ◽  
Sara Abedinzadegan Abdi ◽  
Jennifer L. Hawker ◽  
Leanne G. Fong ◽  
...  
Keyword(s):  
Sodium Bicarbonate ◽  
High Dose ◽  
High Dose Methotrexate ◽  
Dose Methotrexate ◽  
Urine Alkalinization ◽  
Oral Sodium

Safety and efficacy of a urine alkalinization protocol developed for high-dose methotrexate patients during intravenous bicarbonate shortage

2019 ◽  
Vol 25 (8) ◽  
pp. 1860-1866 ◽  
Author(s):  
Amanda M Roy ◽  
Matthew Lei ◽  
Uvette Lou
Keyword(s):  
Sodium Bicarbonate ◽  
Creatinine Clearance ◽  
Urine Output ◽  
Retrospective Chart Review ◽  
High Dose ◽  
High Dose Methotrexate ◽  
Urine Ph ◽  
Dose Methotrexate ◽  
Mean Time ◽  
Intravenous Sodium

Purpose Urinary alkalinization with intravenous sodium bicarbonate is standard during high-dose methotrexate administration. Due to a national intravenous sodium bicarbonate shortage, a urinary alkalinization protocol involving hyperhydration with intravenous fluids, oral bicarbonate, and intravenous or oral acetazolamide was utilized from 10 April to 30 May 2017 (“shortage protocol”). This study compared outcomes between protocols. Methods A single-center, retrospective chart review was conducted for adults who received methotrexate ≥500 mg/m2 on ≥ two occasions, at least once during each protocol, between 19 February and 19 July 2017. Results Eighteen patients (50% male), median age 65 years, received 76 total high-dose methotrexate cycles. Shortage protocol was used in 37 cycles (48.7%). Mean time to methotrexate clearance did not differ between groups (p = ns). Mean time to urinary alkalinization and duration of hospitalization were not statistically different (p = 0.49 and 0.23, respectively). Average total bicarbonate administered per 24 hours was higher in standard protocol (p < 0.05), but hydration rates were similar (p = 0.73). Creatinine clearance and urine output on days 1 and 2 post-high-dose methotrexate did not significantly differ (creatinine clearance day 1, p = 0.27; creatinine clearance day 2, p = 0.55; urine output day 1, p = 0.62; urine output day 2, p = 0.60). Interruptions in alkalinization were significantly higher during shortage (0.41 ± 0.75 instances of urine pH < 7 during standard vs. 1.3 ± 1.7 under shortage, p < 0.05).

Retrospective evaluation of sodium acetate use for urine alkalinization in patients receiving high dose methotrexate

2021 ◽  
pp. 107815522110602
Author(s):  
Cassandra L Perkey ◽  
Laura A Flynn ◽  
Katie Lentz ◽  
Sara Butler
Keyword(s):  
Sodium Bicarbonate ◽  
Sodium Acetate ◽  
Similar Efficacy ◽  
Primary Objective ◽  
High Dose ◽  
High Dose Methotrexate ◽  
Efficacy And Safety ◽  
Dose Methotrexate ◽  
Urine Alkalinization ◽  
Intravenous Sodium

Purpose Methotrexate is an antifolate agent used in treatment of several malignancies. Many toxicities accompany methotrexate that are minimized with urine alkalinization. Parenteral sodium bicarbonate is the historical standard alkalinizing agent, but use has been limited by intermittent shortages. However, intravenous sodium acetate may be considered as a chemically equivalent alternative. The primary objective of this study is to determine the efficacy of sodium acetate versus sodium bicarbonate for urine alkalinization for high-dose methotrexate (HDMTX). Methods This is a retrospective cohort study including adults admitted to Barnes-Jewish Hospital to receive HDMTX for lymphoma, breast cancer with leptomeningial spread, or osteosarcoma. Patients must have received intravenous sodium acetate or sodium bicarbonate alkalinization. Results Of 192 HDMTX encounters, 154 (sodium bicarbonate, n = 86; sodium acetate, n = 68) were evaluated for efficacy and safety. Safety outcomes were not significantly different between groups except for higher peak methotrexate level in the bicarbonate group (2.9 mcmol/L vs. 1.7 mcmol/L, p = 0.023), and increased incidence of grade 3–4 ALT in the sodium bicarbonate group (23.5% vs. 9%, p = 0.02). Time from alkalinizer initiation to pH ≥7 was significantly shorter with sodium bicarbonate (4 vs. 5.15 h, p = 0.021). Nonetheless, outcomes such as length of stay (4.4 vs. 4 days respectively, p = 0.037) and time to methotrexate clearance (3.6 vs. 3.2 days respectively, p = 0.023) reveal that inpatient time was shorter with sodium acetate overall. Conclusion This retrospective analysis suggests that sodium acetate has similar efficacy and safety to sodium bicarbonate for alkalinization and may be considered as an alternative in future shortage situations.

Oral sodium bicarbonate protocol for high-dose methotrexate urine alkalinization: A pediatric experience

2020 ◽  
pp. 107815522091576
Author(s):  
Mark Diachinsky ◽  
Tracey Tran ◽  
Jennifer Jupp ◽  
Krista McKinnon
Keyword(s):  
Adverse Effects ◽  
Sodium Bicarbonate ◽  
Chart Review ◽  
Retrospective Chart Review ◽  
High Dose ◽  
Children's Hospital ◽  
Children’S Hospital ◽  
Urine Alkalinization ◽  
Feasible Alternative ◽  
Oral Sodium

Introduction Methotrexate (MTX) is a cytotoxic antimetabolite. Intravenous (IV) hydration and urine alkalinization with sodium bicarbonate (NaHCO3) can mitigate nephrotoxicity associated with high-dose MTX (HDMTX, doses ≥500 mg/m2). A shortage of IV NaHCO3 in 2017 prompted Alberta Children’s Hospital (ACH) and Stollery Children’s Hospital (SCH) to adopt an alternative protocol including oral NaHCO3 and IV hydration with Lactated Ringer’s (LR). Methods A retrospective chart review was conducted for ACH and SCH inpatients who received HDMTX between January and December 2017. The primary outcome was the proportion of cycles with delayed HDMTX clearance within the IV and oral cohorts. Secondary outcomes include NaHCO3 administered until clearance, NaHCO3 required to reach pH ≥7, time to reach pH ≥7, incidence of pH <7, time to clearance, and time to discharge. Adverse effects associated with delayed clearance or NaHCO3 administration were also reported. Results 112 MTX cycles were included, 50 and 62 from the IV and oral cohorts, respectively. Clearance delays beyond protocol expectations occurred in 10 cycles (8.9%), 5 from each cohort ( p = 0.72). Differences between cohorts were not statistically significant, except the amounts of NaHCO3 required until clearance (383 vs. 277 mmol/m2, p = 0.005) and to reach pH ≥7 (52 vs. 40 mmol/m2, p = 0.004) were lower in the oral cohort. Incidences of adverse effects were not different. Conclusions Oral NaHCO3 with LR is a feasible alternative for urine alkalinization. The total dose of NaHCO3 utilized was lower in the oral cohort, with no additional delays in clearance.

scholarly journals A single center retrospective analysis of a protocol for high-dose methotrexate and leucovorin rescue administration

2017 ◽  
Vol 25 (1) ◽  
pp. 76-84 ◽  
Author(s):  
Zak Cerminara ◽  
Alison Duffy ◽  
Jennifer Nishioka ◽  
James Trovato ◽  
Steven Gilmore
Keyword(s):  
Medical Center ◽  
Cost Savings ◽  
Retrospective Chart Review ◽  
Patient Characteristics ◽  
High Dose ◽  
High Dose Methotrexate ◽  
Protocol Implementation ◽  
Dose Methotrexate ◽  
Before And After ◽  
The Cost

Background Methotrexate has a wide dosing range. High-dose methotrexate is a dose of 1000 mg/m2 or greater. In the 1970s, the incidence of mortality associated with High-dose methotrexate ranged from 4.6 to 6%. In 2012, the University of Maryland Medical Center implemented a standardized high-dose methotrexate protocol. The purpose of this study was to evaluate whether the institution followed recommendations based on the Bleyer nomogram for the administration of high-dose methotrexate more closely after the implementation of the protocol. Methods In this retrospective chart review, 37 patients received 119 cycles of high-dose methotrexate before the protocol implementation (1 January 2009 through 31 December 2010) and 45 patients received 106 cycles of high-dose methotrexate after protocol implementation (1 January 2013 through 31 December 2014). Patient characteristics, protocol data, and complications were analyzed. Results Protocol implementation significantly reduced the deviation of methotrexate level timing at 24, 48, and 72 h: median 7.47 vs. 1.46 h, 7.23 vs. 1.35 h, and 7.00 vs. 1.52 h before and after implementation, respectively (p < 0.0001 for each). The protocol significantly reduced deviation of the first dose of leucovorin administration: median 5.2 vs. 0.675 h before and after implementation, respectively (p<0.0001). After protocol implementation, there was an increase in the use of leucovorin prescriptions written appropriately for patients discharged before methotrexate levels reached a value of ≤0.05 µmol/L. Conclusions Implementation of a protocol for the administration of high-dose methotrexate improved the adherence to consensus recommendations. Further analysis is needed to assess clinical pharmacist involvement and the cost savings implications within this protocol.

Outcomes Associated with Reducing the Urine Alkalinization Threshold in Patients Receiving High-Dose Methotrexate

2017 ◽  
Vol 37 (6) ◽  
pp. 684-691 ◽  
Author(s):  
Sarah A. Drost ◽  
Jason R. Wentzell ◽  
Pierre Giguère ◽  
Darcy L. McLurg ◽  
Mitchell Sabloff ◽  
...  
Keyword(s):  
High Dose ◽  
High Dose Methotrexate ◽  
Dose Methotrexate ◽  
Urine Alkalinization

Comparison of enteral and parenteral methods of urine alkalinization in patients receiving high-dose methotrexate

2016 ◽  
Vol 23 (1) ◽  
pp. 3-9 ◽  
Author(s):  
Jamie A Rouch ◽  
Bradley Burton ◽  
Alix Dabb ◽  
Vicky Brown ◽  
Amy H Seung ◽  
...  
Keyword(s):  
Sodium Bicarbonate ◽  
Sodium Citrate ◽  
Primary Objective ◽  
High Dose ◽  
Renal Tubules ◽  
Citric Acid Solution ◽  
Urine Ph ◽  
Routes Of Administration ◽  
Dose Methotrexate ◽  
Urine Alkalinization

Purpose Hyperhydration and urinary alkalinization is implemented with all high-dose (HD)-methotrexate infusions to promote excretion and prevent precipitation of methotrexate in the renal tubules. Our institution utilized enteral alkalinizing agents (sodium bicarbonate tablets and sodium citrate/citric acid solution) to alkalinize the urine of patients receiving HD-methotrexate during a parenteral sodium bicarbonate and sodium acetate shortage. The purpose of this study is to establish the safety and efficacy of the enteral route for urine alkalinization. Methods A single-center, retrospective, cohort study was conducted comparing cycles of HD-methotrexate using enteral alkalinizing agents to parenteral sodium bicarbonate. The primary objective was to compare the time, in hours, from administration of first inpatient administered dose of alkalinizing agent to time of achieving goal urine pH. Secondary objectives evaluated total dose of sodium bicarbonate required to achieve goal urine pH, time from start of urine alkalinizing agent until time of achieving methotrexate level safe for discharge, and toxicities associated with methotrexate and the alkalinizing agents. Results A total of 118 patients were included in this study, equally divided into two cohorts based on parenteral versus enteral routes of administration. No statistical difference was determined between the two cohorts regarding time to goal urine pH (6.5 h versus 7.9 h, P = 0.051) or regarding time to methotrexate level deemed safe for discharge (63.5 h versus 62.5 h, p = 0.835). There were no significant differences in methotrexate-induced toxicities. Conclusion Our study found enteral routes of urine alkalinization to be a viable alternative to the traditional parenteral sodium bicarbonate, especially during parenteral sodium bicarbonate and acetate shortages.

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