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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
108
Combination of Simvastatin with Standard Chemotherapy scheme for acute lymphoblastic patients.
Hospital General de México "Dr. Eduardo Liceaga"
Mexico City, Mexico
RECRUITINGHospital Discharge
The event in which patient is discharge from Hospital stay,
Time frame: 3 months
Feverish Event
Determination of a temperature above 38 ° persistently for more than 30 minutes
Time frame: 3 months
Sepsis
Presence of hemodynamic alterations characterized by persistent hypotension, elevated heart rate, fever, and abnormal respiration
Time frame: 3 months
Neutrophils count
Number of neutrophils found in peripheral blood at the end of each chemotherapy cycle
Time frame: 3 months
Platelets count
Number of platelets found in peripheral blood at the end of each chemotherapy cycle
Time frame: 3 month
Blasts in marrow
Presence of more than 5% of blasts in bone marrow after each chemotherapy cycle
Time frame: 3 month
Neutrophil recovery time
Time in days for neutrophil recovery
Time frame: 1 month
Bacterial isolation
Description of the germ isolated in cultures during follow-up
Time frame: 3 months
Procalcitonin
Biomarker used in infectious and inflammatory processes associated mainly with gram-negative germs, this measurement is routine in the follow-up of individuals with febrile neutropenia
Time frame: 3 months
Hospital Stay
Measurement of days of hospital stay
Time frame: 1 month
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