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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05425524
Other study ID # IRB.521/62
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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