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IRCT20190425043368N1 IRCT 2019-06-02 Shiraz University of Medical Sciences The comparison between short and long infusion of Ampicillin-Sulbactam in patients with sepsis and severe sepsis in the intensive care unit of Namazee and shahid Rajaee hospital in Shiraz. The evaluation of clinical and laboratory efficacy of four-hour infusion vs. half-hour infusion of Ampicillin-Sulbactam in empiric and definite treatment of patients with sepsis and severe sepsis in the intensive care unit of Namazee and shahid Rajaee hospital in Shiraz. 2019-05-22 anticipated 136 Complete https://irct.ir/trial/39212 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Method of randomization: Permuted block randomization. Unit of randomization: Individual. Tools used in randomization: computer software, Blinding description: In this study, the participants, the principle investigator, the physicians and the data collectors are blinded. The patients who are going to receive the drug as short or long infusion, are determined by numbers and these numbers are given to the head nurse and nurses of the ICU. 3 Condition 1: Severe Sepsis. Condition 2: Sepsis. Intervention 1: Intervention group: Receiving Ampicillin-Sulbactam as a 4-hour infusion Patients receive 9 grams Ampicillin-Sulbactam every 8 hours, which is the therapeutic dose for resistant pathogens (3 Ampicillin-Sulbactam 3 gram vials every 8 hours, Jaber ebne hayyan pharmaceutical co). Infusion pumps will be used to determine the exact time of infusion. All the patients will receive this drug for at least 3 days. The decision to continue or stop drug is based on the microbial culture results and the patient's condition. Intervention 2: Control group: Receiving Ampicillin-Sulbactam as a 0.5-hour infusion Patients receive 9 grams Ampicillin-Sulbactam every 8 hours, which is the therapeutic dose for resistant pathogens (3 Ampicillin-Sulbactam 3 gram vials every 8 hours, Jaber ebne hayyan pharmaceutical co). The drug is administered as the routine protocol which is 0.5-hour infusion. All the patients will receive this drug for at least 3 days. The decision to continue or stop drug is based on the microbial culture results and the patient's condition. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Mahtabalsadat Mirjalili
Shiraz school of pharmacy, Karafarin Street, Roknabad Town
Shiraz Iran (Islamic Republic of) 713451583 +98 71 3242 4127 mahtab.mirjalili@gmail.com Shiraz University of Medical Sciences scientific Mahtabalsadat Mirjalili
Shiraz school of pharmacy, Karafarin street, Roknabad Town
Shiraz Iran (Islamic Republic of) 713451583 +98 71 3242 4127 mahtab.mirjalili@gmail.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) More than 18 years old Diagnosis of sepsis and severe sepsis based on qSOFA criteria Taking Ampicillin- Sulbactam at least for three days 18 years no limit Both Pregnancy Sensitivity to Ampicillin- Sulbactam Receiving Ampicillin- Sulbactam more than 24 hours during 1 week before being admitted to the intensive care unit Patients with GFR<10 ml/min or hemodialysis Patients with Pseudomonas, penicillin-resistant staph aureus (MRSA), or stenotrophomonas R65.2 A41.9 Severe sepsis Sepsis, unspecified organism Treatment - Drugs Treatment - Drugs Intervention group: Receiving Ampicillin-Sulbactam as a 4-hour infusion Patients receive 9 grams Ampicillin-Sulbactam every 8 hours, which is the therapeutic dose for resistant pathogens (3 Ampicillin-Sulbactam 3 gram vials every 8 hours, Jaber ebne hayyan pharmaceutical co). Infusion pumps will be used to determine the exact time of infusion. All the patients will receive this drug for at least 3 days. The decision to continue or stop drug is based on the microbial culture results and the patient's condition. Control group: Receiving Ampicillin-Sulbactam as a 0.5-hour infusion Patients receive 9 grams Ampicillin-Sulbactam every 8 hours, which is the therapeutic dose for resistant pathogens (3 Ampicillin-Sulbactam 3 gram vials every 8 hours, Jaber ebne hayyan pharmaceutical co). The drug is administered as the routine protocol which is 0.5-hour infusion. All the patients will receive this drug for at least 3 days. The decision to continue or stop drug is based on the microbial culture results and the patient's condition. Clinical cure (resolution of signs and symptoms related to the infection, including hypothermia or hyperthermia, low platelet count, high heart rate, high respiratory rate or low PaCO2, abnormal white blood cell count and positive microbial culture. Timepoint: At the end of therapy and 14 days after cessation of antibiotic. Method of measurement: Individual examination, measuring temperature by thermometer, complete blood count and determination of platelet and white blood cell count, measurement of heart rate and respiratory rate, analysis of blood gases, microbial culture. Shiraz University of Medical Sciences Approved 2019-03-10 Ethics committee of Shiraz University of Medical Sciences School of Pharmacy, Shiraz-Marvdasht Highway,Rokn Abad Town Shiraz Fars Iran (Islamic Republic of)