Effect of Simvastatin on Sepsis and Febrile Neutropenia in Patients With Acute Lymphoblastic Leukemia
试验速览
- 阶段
- 4 期
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Neutrophils count
研究概览
简要总结
In general, the percentage of complete remissions is 85 - 90 % for acute lymphoid leukemia (ALL). In developing countries, percentages are lower secondary to higher sepsis-related mortality. Although the effect of statins on inflammatory response associated with sepsis has been demonstrated, including an effect on bacterial proliferation in patients with a state of immunosuppression, their effect has not been demonstrated so far in patients with hemato-oncological cancer.
详细描述
Death associated with sepsis is one of the principal complications related to chemotherapy treatment; there are currently no strategies to prevent its development besides the use of prophylactic antibiotics or granulocyte colony stimulants to reduce the period of febrile neutropenia. Most of the trials on the use of statins are retrospective with controversial results and include patients with different clinical situations that conditioned the septic study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with acute leukemia under treatment of a chemotherapy regimen
- •Stable performance status (ECOG: 0 or Karnofsky scale greater than 80%) at time of analysis and under chemotherapy regimen
- •Life expectancy greater than 48 hours after diagnosis
- •Oral route available
- •Have signed informed consent at the time of the study
- •Patients whose chemotherapy regimen is administered in a hospital rather than an outpatient manner
排除标准
- •Patients with acute leukemias over 55 years of age and with impaired functional status at the time of diagnosis
- •Elevation of liver enzymes 3 times higher than the range established by the central laboratory
- •Persistent kidney involvement despite having adequate hydration
- •Pregnant patients
- •Patients with peripheral neuropathy considered severe or disabling grade
- •Patients with a history of psychiatric disorders or psychotic attacks
- •Individuals who do not have the oral route available, who are maintained with a nasogastric tube, or who require support for the diagnosis through parenteral nutrition
- •Patients undergoing peritoneal dialysis or hemodialysis treatment
- •Patients with leukemia associated with Down syndrome
- •Patients under low-intensity chemotherapy regimen or palliative regimen
- •Previous allergy to any statin component
- •Patients with a history of liver failure (Child-Pugh Stage B or C)
研究组 & 干预措施
Simvastatin Treatment Group
Patients will combine the standard CALGB treatment scheme plus Simvastatin 10mg orally every 24 hours during the first 7 days of treatment and then continue with 20mg every 24 hours until the end of treatment and hospitalization.
干预措施: Simvastatin (Drug)
结局指标
主要结局
Neutrophils count
时间窗: 3 months
Number of neutrophils found in peripheral blood at the end of each chemotherapy cycle
Feverish Event
时间窗: 3 months
Determination of a temperature above 38 ° persistently for more than 30 minutes
Hospital Discharge
时间窗: 3 months
The event in which patient is discharge from Hospital stay,
Sepsis
时间窗: 3 months
Presence of hemodynamic alterations characterized by persistent hypotension, elevated heart rate, fever, and abnormal respiration
Platelets count
时间窗: 3 month
Number of platelets found in peripheral blood at the end of each chemotherapy cycle
Blasts in marrow
时间窗: 3 month
Presence of more than 5% of blasts in bone marrow after each chemotherapy cycle
Neutrophil recovery time
时间窗: 1 month
Time in days for neutrophil recovery
次要结局
- Bacterial isolation(3 months)
- Procalcitonin(3 months)
- Hospital Stay(1 month)
研究者
Christian Omar Ramos-Peñafiel, MD, PhD
Principal Investigator
Hospital General de Mexico