Diabetes Mellitus
Conditions
Interventions
52 diabetic patients hospitalized for severe sepsis or septic shock will participate in the study. After randomization, 26 patients will receive medication (ranitidine) and 26 will receive placebo (sa
2- Isotonic saline solution (placebo), intravenous, 120 mL every 6 hours for 7 days. If the patient has creatinine clearance <50mL / min, the 120mL dose will be used every 12 hours
In addition to the above intervention, patients from both groups will continue to receive similarly the treatment of the clinical condition that will lead to hospitalization, according to the protocol
Drug
D03.383.312.750
Sponsors
Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patient with age greater than 18 years; Admitted to the Emergency Unit of Clinical Hospital of Ribeirão Preto medical school of University of São Paulo (UE-HCFMRP/USP); diagnosis of diabetes mellitus or serum glucose > 200 mg / dL at the admission; diagnosis of severe sepsis or septic shock; ability of the patient or his or her legal representative to decide whether or not to participate in the survey before completing 48 hours of admission.
Exclusion criteria
Exclusion criteria: Septic Patients who do not have the criteria for severe sepsis or septic shock; continuous use of ranitidine or other H2 antagonist; hypersensitivity to ranitidine or other H2 blockers; pregnant women; participation in another study; diagnosis of HIV; realization of chemotherapy in the last 30 days; palliative care; lymphoproliferative disease; refusal to signing the consent form (CF) or not to participate in the study; need of procedure or examination with contrast which requires the use of ranitidine as premedication.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| main: Increased Migration of neutrophils assessed by counting in the neubauer chamber, with 50% increase at day 7 compared to baseline; ;Increased expression of the CXCR2 receptor on neutrophils, as measured by the flow cytometer, with 50% more at day 7 compared to baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| Levels of histamine dosed by ELISA will be higher in the placebo group compared to those who received treatment after 2 and 7 days of intervention.;Levels of inflammatory cytokines evaluated by ELISA, which will be higher in the placebo group compared to those receiving treatment after 2 and 7 days of intervention.;SOFA variation at days zero, two and seven (d2-d7; d0-d7; d0-d2), with lower variation values in the ranitidine group compared with placebo group.;Survival in 7 days and hospital survival, with a higher survival rate in the ranitidine group compared with placebo. | — |
Countries
Brazil
Contacts
Public ContactDaniel Zoppi
Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
Outcome results
None listed