Detection and Management of Acute Kidney Injury (AKI) in Low and Low Middle Income Countries: A Pilot Feasibility Project

Acute Kidney Injury Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02912611
• Other study ID #: 160610
• Status: Completed
• Phase: N/A
• Start date: October 1, 2016
• Est. completion date: March 31, 2018

Study information

• Verified date: July 2020
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2101
• Est. completion date: March 31, 2018
• Est. primary completion date: September 29, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury

Intervention

Procedure:
• Education and Protocol based management

Locations

Country	Name	City	State
Bolivia	Hospital Obrero #2	Cochabamba
Malawi	Queen Elizabeth Central Hospital (QECH)	Blantyre
Nepal	BP Koirala Institute of Health Sciences	Dharan Bazar	Sansari District

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Diego	International Society of Nephrology

Countries where clinical trial is conducted

Bolivia,  Malawi,  Nepal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess the feasibility of implementing an education and training program to optimize care of AKI	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.	1 year