Reduced IV Fluids to Improve Clearance of HDMTX in Children w/Lymphoma or Acute Lymphoblastic Leukemia

Overseen By Lindsey B Gwaltney, RN

Age: < 18

Sex: Any

Trial Phase: Phase 1

Sponsor: Virginia Commonwealth University

Disqualifiers: Trisomy 21, Dialysis, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

10 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing if giving patients less fluid through an IV after a high dose of methotrexate can help clear the drug faster compared to the usual amount of fluid. It targets patients who receive high doses of methotrexate and need effective hydration to remove the drug from their system. The study alternates between different fluid amounts to see which works better. Methotrexate is a cytotoxic agent used to treat several malignancies, and its clearance can be influenced by hydration levels.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What data supports the effectiveness of intravenous fluids as a treatment?

Intravenous fluids are commonly used in hospitals to help patients who are very sick, especially when they can't drink enough fluids or need help with blood circulation. Studies show that the type and amount of fluid given can affect how well patients recover, with balanced solutions often being preferred for better outcomes. ^{1 2 3 4 5}

Is intravenous fluid therapy generally safe for humans?

Intravenous fluid therapy is commonly used in hospitals, but it can have side effects like errors in administration, which may lead to serious complications. In children, using the wrong type of fluid can cause issues like low sodium levels and brain swelling. It's important for healthcare providers to carefully choose the right type and amount of fluid to ensure safety. ^{3 6 7 8 9}

How is intravenous fluid therapy different from other treatments?

Intravenous fluid therapy is unique because it directly delivers fluids into the bloodstream, allowing for rapid correction of fluid and electrolyte imbalances, especially in acutely ill patients. Unlike oral treatments, it is used when patients cannot take fluids by mouth, and it can be tailored in composition and rate to meet specific medical needs. ^{3 4 10 11 12}

Research Team

Cady P Noda, PharmD

Principal Investigator

Virginia Commonwealth University

Eligibility Criteria

Inclusion Criteria

Creatinine clearance ≥ 65 mL/min by modified Schwartz equation

Patients of childbearing potential must have a negative pregnancy test (serum or urine)

Lactating female patients must agree not to nurse a child while on this trial

Exclusion Criteria

Known or suspected pleural effusion

Trisomy 21

History of dialysis within 30 days prior to study registration or currently on dialysis

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo 4 cycles of High Dose Methotrexate (HDMTX) with alternating standard and reduced volume hydration regimens

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including effects on therapy delays, fluid overload, severe mucositis, and kidney toxicity

12 weeks

Treatment Details

Interventions

• Intravenous fluids

Participant Groups

Group I: Reduced hydration regimen Experimental Treatment 1 Intervention

The reduced intravenous fluid (IVF) protocol, post HDMTX IVF will be initiated at 62.5 mL/m2/hr following completion of HDMTX infusion.

Group II: Standard Hydration Regimen Active Control 1 Intervention

In the standard intravenous fluid (IVF) protocol, following completion of HDMTX infusion, post HDMTX IVF will be initiated at 125 mL/m2/hr (no maximum mL/hr total rate).

Who Is Running the Clinical Trial?

Virginia Commonwealth University

Lead Sponsor

Trials

732

Recruited

22,900,000+

Findings from Research

In a study of 2825 patients across 61 ICUs in Australia and New Zealand, the use of crystalloid fluids for resuscitation significantly increased from 28.9% in 2007 to 50.5% in 2013, indicating a shift towards these fluids in critical care.

The use of colloid fluids decreased notably during the same period, particularly gelatin-based colloids, which dropped from 28.9% to just 2.1%, suggesting a change in preference towards buffered salt solutions for better patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Resuscitation fluid use in Australian and New Zealand Intensive Care Units between 2007 and 2013. Hammond, NE., Taylor, C., Saxena, M., et al.[2018]

References

1. England pubmed.ncbi.nlm.nih.gov

Conservative fluid therapy in septic shock: an example of targeted therapeutic minimization. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Pilot randomized controlled trial of restricted versus liberal crystalloid fluid management in pediatric post-operative and trauma patients. [2023]

3. Czech Republic pubmed.ncbi.nlm.nih.gov

Intravenous fluid therapy in acutely ill patients for non-intensivists. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Issuing of isotonic crystalloid solutions to Danish public hospitals in 2021-A retrospective nationwide observational study. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Resuscitation fluid use in Australian and New Zealand Intensive Care Units between 2007 and 2013. [2018]

6. Spain pubmed.ncbi.nlm.nih.gov

Do we overestimate intravenous fluid therapy needs? Adverse effects related to isotonic solutions during pediatric hospital admissions. [2023]

7. Norway pubmed.ncbi.nlm.nih.gov

Intravenous isotonic fluids induced a positive trend in natraemia in children admitted to a general paediatric ward. [2017]

8. England pubmed.ncbi.nlm.nih.gov

Factors predictive of intravenous fluid administration errors in Australian surgical care wards. [2018]

9. England pubmed.ncbi.nlm.nih.gov

Standardisation of intravenous infusion therapy for paediatrics: big challenges for the little patients. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Intravenous maintenance fluid tonicity and hyponatremia after major surgery- a cohort study. [2022]

11. England pubmed.ncbi.nlm.nih.gov

The use of crystalloidal and colloidal solutions for volume replacement in hypovolemic shock. [2005]

12. United States pubmed.ncbi.nlm.nih.gov

Intravenous fluid management for the acutely ill child. [2022]