sepsis with thrombocytopenia
Conditions
Interventions
control group:antimicrobial therapy alone
oseltamivir group:antimicrobial therapy plus oseltamivir
Sponsors
Qilu Hospital, Shandong University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: In Study I, patients were eligible for enrollment if they were 18 to 80 years of age; if they presented with sepsis, severe sepsis, or septic shock; and if they had thrombocytopenia (platelet counts less than 100 × 10^9/L) at their admission. To detect platelet desialylation levels, gender and age matched heathy adults were selected as normal controls. In Study II, we only included the severe sepsis patients whose platelet counts were less than 50 × 10^9/L. The diagnostic criteria for sepsis, severe sepsis, and septic shock were based on the Surviving Sepsis Campaign guidelines. Briefly, sepsis was defined by a documented or suspected infection plus at least two the following conditions: temperature higher than 38.3°C or lower than 36°C, heart rate more than 90 beats/min, tachypnea, altered mental status, substantial edema or positive fluid balance, hyperglycemia in the absence of diabetes, white blood cell (WBC) count greater than 12×10^9/L or less than 4×10^9/L, elevated plasma C-reactive protein, elevated plasma procalcitonin, et al. Severe sepsis was defined as sepsis plus organ dysfunction. Septic shock was defined as sepsis plus hypotension (refractory to intravenous fluids) or hyperlactatemia. Thrombocytopenia was defined as a peripheral blood platelet count less than 100,000/uL.
Exclusion criteria
Exclusion criteria: The exclusion criteria were as follows: (1) patients with malignancies or bone marrow stem cell disorders within the last two years; (2) patients who received chemotherapy or immunosuppressive agents within 6 months; (3) patients who had a history of ITP or such autoimmune diseases; (4) patients after cardiopulmonary resuscitation (CPR); (5) pregnant patients; (6) patients having acute gastrointestinal hemorrhage; (7) patients who have a history of bone marrow, lung, liver, kidney, or small bowel transplantation; (8) patients with end-stage hepatic or renal failure; (9) patients with disseminated intravascular coagulation (DIC); and (10) patients with drug (eg., antibiotics or heparin)-associated thrombocytopenia.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| platelet desialylation level;platelet overall response;all-cause mortality within 28 days after randomization; | — |
Secondary
| Measure | Time frame |
|---|---|
| platelet recovery time;occurrence of bleeding events;amount of platelets transfused; | — |
Countries
China
Contacts
Public ContactJun Peng
Departments of Hematology, Qilu hospital, Shandong University
Outcome results
None listed