Leptospirosis Care Bundle Study

NCT05425524 — Not applicable, Recruiting, 300 participants, Chulalongkorn University

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Leptospirosis Care Bundle Study: A Randomized Controlled Trial

Registry	NCT05425524
Status	Recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: single, treatment
Enrollment	300 (Estimated)
Sponsor	Chulalongkorn University (Other)
Conditions	Leptospirosis
Interventions	Care Bundle (Procedure)
Dates	start 2019-10-01, primary completion 2022-01-19, completion 2026-12-31 (estimated), first posted 2022-06-21, last updated 2026-10-02
Locations	1 site in Thailand

-Summary

So in management of Leptospirosis patients There really is no another approach to treatment. The importance of the problem was acknowledged by the researchers. As a result, this study was performed in order to The Leptospirosis Care Bundle has been used, and has been proved that its use can reduce the risk of acute renal failure.

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+Arms and interventions

Arm	Type	Interventions	Description
Care Bundle Group	Experimental	Procedure: Care Bundle	Treatment step by step we have 5 steps STEP 1: Leptospirosis suspected case STEP 2: Investigations STEP 3: Antibiotics within 1 hour after Hemocultures were taken STEP 4: Intravenous Fluid STEP 5: Stage-Base Management of AKI (KDIGO)
Control Group	No intervention

Care Bundle (Procedure): Treatment step by step we have 5 steps STEP 1: Leptospirosis suspected case STEP 2: Investigations STEP 3: Antibiotics within 1 hour after Hemocultures were taken STEP 4: Intravenous Fluid STEP 5: Stage-Base Management of AKI (KDIGO)

+Outcome measures

Primary outcomes

Number of Participants with Reduce AKI in 72 hours [72 hours]: To see if using care bundle for leptospirosis patients can improve reduce the incidence of acute renal failure in the first 72 hours of being admitted to hospital.It classified AKI into three categories (risk, injury, and failure) according to the status of serum creatinine (SCr) and urine output (UO) by AKIN/KDIGO

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* age > 18 years
* Suspicious Leptospirosis including body temperature > 38 celcius, Severe myalgia, and exposure to reservoir hospital of flood water.
* Calf muscle tenderness
* Conjunctival suffusion
* Anuria or oliguria and/or proteinuria
* Jaundice
* Hemorrhagic manifestations (pulmonary and intestine)
* Meningeal irritation
* Nausea, vomiting, abdominal pain, diarrhea.
* Admitted in hospital

Exclusion Criteria:

* other infectious disease
* pregnancy

+Locations (1)

Facility	City	Country	Status
Chulalongkorn university	Bangkok, Bangkok	Thailand	Recruiting