Leptospirosis Care Bundle Study: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Chulalongkorn University
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- Number of Participants with Reduce AKI in 72 hours
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •Hemorrhagic manifestations (pulmonary and intestine)
- •Meningeal irritation
- •Nausea, vomiting, abdominal pain, diarrhea.
- •Admitted in hospital
Exclusion Criteria
- •other infectious disease
- •pregnancy
Arms & Interventions
Care Bundle Group
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)
Intervention: Care Bundle (Procedure)
Control Group
Outcomes
Primary Outcomes
Number of Participants with Reduce AKI in 72 hours
Time Frame: 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
Secondary Outcomes
No secondary outcomes reported
Investigators
Nattachai Srisawat ,M.D.
Assoc. Prof. Dr.Nattachai Srisawat
Chulalongkorn University