Preventive Strategies for Early and Late Complications of Leptospirosis

PHASE2RecruitingINTERVENTIONAL
Enrollment

678

Participants

Timeline

Start Date

April 12, 2024

Primary Completion Date

March 31, 2026

Study Completion Date

March 31, 2026

Conditions
Leptospirosis
Interventions
BIOLOGICAL

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.

DEVICE

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.

DEVICE

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"

OTHER

Conventional therapy

Conventional therapy for leptospirosis includes antibiotics, fluids, inotropes, renal replacement therapy, ventilator support, and other treatment that the attending physician deems necessary.

Trial Locations (3)

1000

ACTIVE_NOT_RECRUITING

Institute of Human Genetics, National Institutes of Health - University of the Philippines Manila, Manila

1003

NOT_YET_RECRUITING

San Lazaro Hospital, Manila

1100

RECRUITING

National Kidney and Transplant Institute, Quezon City

All Listed Sponsors
collaborator

San Lazaro Hospital, Philippines

UNKNOWN

collaborator

Institute of Human Genetics, National Institutes of Health - University of the Philippines Manila, Philippines

UNKNOWN

collaborator

Department of Science and Technology, Philippines

UNKNOWN

lead

National Kidney and Transplant Institute, Philippines

OTHER