Leptospirosis Care Bundle Study

Leptospirosis Clinical Trial

Official title:

Leptospirosis Care Bundle Study: A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05425524
• Other study ID #: IRB.521/62
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2019
• Est. completion date: January 2024

Study information

• Verified date: May 2023
• Source: Chulalongkorn University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: January 2024
• Est. primary completion date: January 19, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Leptospirosis

Intervention

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)

Locations

Country	Name	City	State
Thailand	Chulalongkorn university	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Chulalongkorn University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Reduce AKI in 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	72 hours