Clinical trial NCT02912611: Detection and Management of Acute Kidney Injury (AKI) in Low and Low Middle Income Countries: A Pilot Feasibility Project
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Kidney Injury
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: International Society of Nephrology
First posted: 2016-09-23
Enrollment: 2101
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: Inclusion Criteria: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)

Exclusion Criteria:

* Chronic kidney disease in patients receiving regular dialysis treatment
* Kidney transplant patients
* Unable to give informed consent

Primary outcomes:
measure: Assess the feasibility of implementing an education and training program to optimize care of AKI
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Cochabamba
country: Bolivia
facility: Hospital Obrero #2
city: Blantyre
country: Malawi
facility: Queen Elizabeth Central Hospital (QECH)
city: Dharān Bāzār
country: Nepal
facility: BP Koirala Institute of Health Sciences
state: Sansari District
Study officials:
References: