678
Participants
Start Date
April 12, 2024
Primary Completion Date
March 31, 2026
Study Completion Date
March 31, 2026
Prophylactic Plasma Transfusion
ABO/Rh-type compatible fresh frozen plasma (FPP) units will be thawed to 37° prior to administration. Plasma transfusion will be administered intravenously, 1 unit for 4 hours every 12 hours. There will be two consecutive days for the transfusion for a total of 4 units.
Hemoperfusion
The hemoperfusion (HP) procedure will follow the standard procedure of National Kidney and Transplant Institute (NKTI) using Jafron HA330 hemoperfusion cartridge. First, an internal jugular catheter is attached to the patient. Alternatively, an arteriovenous fistula or arteriovenous graft may be placed on the patient. The patient will then be hooked to a hemodialysis machine. Blood pump speed will be set to 150-200mL/min, and HP will last for 2 to 2.5 hours. Whole blood will flow through the sorbent HA330 cartridge and back to the patient. Anticoagulation is not necessary due to the short treatment time. Hemoperfusion will be repeated after 12-24 hours for at least three days.
Extracorporeal Membrane Oxygenation
"A veno-venous ECMO (VV ECMO) will be applied by aseptically inserting a venous cannula into the femoral veins. The patients will be hooked to an ECMO machine. Patients without significant bleeding or vascular intervention will be managed with an activated clotting time set at 140-180 sec by 800-1000 U/h of heparin. Otherwise, heparin will be titrated to maintain a partial thromboplastin time of 60-80 sec.~ECMO settings are as follows:~* Mean blood pressure of \>60 mm~* SaO2 at \>90% with a flow of 3.5-4.5 L/min~* Hematocrit at \>35%~* Platelets \>50000-100000/mL~* Transfusions will be done when necessary~Criteria for weaning:~* ABG:~ * pH 7.35-7.45~ * PaO2 \>80 mm Hg~ * PCO2 \<45 mm Hg~* Under the following conditions:~ * Gas blender FiO2 of 0.21~ * Sweep gas of 0 L/min at an ECMO flow of 2 L/min~ * Ventilator mode (if applicable):~ * FiO2 of 0.6~ * Tidal volume of 6 mL/kg~ * PEEP of 8 cmH2O~ * RR of 12-16/min for VV ECMO or 3 L/min of O2 via nasal prong with awakening ECMO patients"
Conventional therapy
Conventional therapy for leptospirosis includes antibiotics, fluids, inotropes, renal replacement therapy, ventilator support, and other treatment that the attending physician deems necessary.
ACTIVE_NOT_RECRUITING
Institute of Human Genetics, National Institutes of Health - University of the Philippines Manila, Manila
NOT_YET_RECRUITING
San Lazaro Hospital, Manila
RECRUITING
National Kidney and Transplant Institute, Quezon City
San Lazaro Hospital, Philippines
UNKNOWN
Institute of Human Genetics, National Institutes of Health - University of the Philippines Manila, Philippines
UNKNOWN
Department of Science and Technology, Philippines
UNKNOWN
National Kidney and Transplant Institute, Philippines
OTHER