Detection and Management of Acute Kidney Injury (AKI) in Low and Low Middle Income Countries: A Pilot Feasibility Project
- Conditions
- Acute Kidney Injury
- Interventions
- Procedure: Education and Protocol based management
- Registration Number
- NCT02912611
- Lead Sponsor
- University of California, San Diego
- Brief Summary
This feasibility study will be conducted at 4 international sites located in Asia (Dhahran, Nepal); Africa (Blantyre, Malawi and Kilimanjaro, Tanzania) and Latin America (Cochabamba, Bolivia).
Each site comprises a cluster (including 3-4 health centers - 1 district hospital - 1 regional referral hospital) that service the population around the site area. Patients presenting at a health care clinic or hospital emergency department with signs and symptoms associated with high and moderate risk of developing AKI will undergo a point of care (POC) test to measure serum creatinine, saliva urea nitrogen dipstick (exclusively in Malawi), and a urine dipstick test for color, protein, glucose, blood and specific gravity. Patients who meet the study inclusion criteria will be approached for consent. Patients enrolled in the study will be followed throughout the health care evaluation and tracked through their course by location i.e. health care center, hospital, and home. Outcomes will be recorded through 6 months following the health care evaluation.
The protocol will have an initial observation phase, during which relevant healthcare staff and the research team will be trained to identify patients at moderate or high risk of AKI and use of the point of care (POC) test for serum creatinine, saliva urea nitrogen dipstick (exclusively in Malawi), and urine dipstick test. During this phase patients will be tracked throughout the health care evaluation, however the teleconsultation will not be implemented and no specific guidance for managing the patient will be provided.
During the subsequent intervention phase, the research team will interact with the local healthcare providers to and the teleconsultation physician, providing guidance on the management of the patient based on a standardized protocol. Protocols for patient care will be pre-specified, with minor adjustments to meet local requirements.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2101
Presence of Signs and Symptoms determining AKI risk
- Decreased urine volume
- Hypotension/ shock
- Coma
- Jaundice
- Confusion
- Dyspnea
- Symptoms of respiratory infection
- Petechia, ecchymosis, bleeding
- Hypertension (in pregnancy)
- Chronic kidney disease in patients receiving regular dialysis treatment
- Kidney transplant patients
- Unable to give informed consent
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Moderate and High risk for AKI Education and Protocol based management -
- Primary Outcome Measures
Name Time Method Assess the feasibility of implementing an education and training program to optimize care of AKI 1 year Managment will be based on a protocol driven comprehensive 5R (Risk, Recognition, Response, Renal Support and Rehabilitation) approach in resource constrained regions in Africa, Asia and Latin America.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (3)
Hospital Obrero #2
🇧🇴Cochabamba, Bolivia
BP Koirala Institute of Health Sciences
🇳🇵Dharān Bāzār, Sansari District, Nepal
Queen Elizabeth Central Hospital (QECH)
🇲🇼Blantyre, Malawi