Preventive Strategies for Early and Late Complications of Leptospirosis

Summary

The goal of this clinical trial is to learn if complement factor I (CFI) works to predict development of complications in participants with leptospirosis. It will also learn if plasma transfusion, hemoperfusion, and extracorporeal membrane oxygenation works to treat participants with leptospirosis. The main questions it aims to answer are:

* Does a low level of CFI predict the development of lung damage in participants with leptospirosis?
* Does plasma tranfusion lower the chances of participants getting lung damage from leptospirosis?
* Does hemoperfusion work to remove harmful materials from the blood of participants with leptospirosis?
* Does extracorporeal membrane oxygenation increase the chance of survival in participants with lung damage?

Researchers will compare plasma tranfusion and hemoperfusion to conventional therapy (standard of care for leptospirosis, including antibiotics, fluids, and other treatment that the doctor deems necessary) to see if these novel therapies work to treat leptospirosis.

Participants will:

* Give blood samples for the study of CFI
* Receive conventional therapy and/or plasma transfusion for 4 times in 2 days, OR
* Receive conventional therapy and/or hemoperfusion for at least 3 days, AND/OR
* Receive extracorporeal membrane oxygenation if their condition worsens

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.

Sponsors & Collaborators

• San Lazaro Hospital, Philippines

  collaborator UNKNOWN

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

  collaborator UNKNOWN

• Department of Science and Technology, Philippines

  collaborator UNKNOWN

• National Kidney and Transplant Institute, Philippines

  lead OTHER

Principal Investigators

• Romina A Danguilan, MD · National Kidney and Transplant Institute, Philippines

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-04-12

Primary Completion

2027-03-31

Completion

2027-03-31

Countries

• Philippines

Study Locations