Last updated 4 years ago

Effect of Simvastatin on Sepsis and Febrile Neutropenia in Patients With Acute Lymphoblastic Leukemia

108 patients around the world

Available in Mexico

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.

Hospital General de Mexico

1Research sites

108Patients around the world

This study is for people with

Leukemia

Acute lymphoblastic leukemia

Requirements for the patient

To 55 Years

All Gender

Medical requirements

: 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

: 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)

Sites

Hospital General de Mexico Dr. Eduardo Liceaga - Ciudad de México

Recruiting

Dr. Balmis 148, Col. Doctores, Del. Cuauhtémoc, Ciudad de México

StudySimvastatin

SponsorHospital General de Mexico

Study typeInterventional

Conditions

Acute lymphoblastic leukemia

Requirements

To 55 YearsAll Gender

Unique study IDclinicaltrials.gov

NCT05133310