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

NCT ID: NCT02912611

Last Updated: 2020-07-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 2101 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-01
• Study Completion Date: 2018-03-31

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.

Conditions

Acute Kidney Injury

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Moderate and High risk for AKI

Group Type: OTHER

Education and Protocol based management

Intervention Type: PROCEDURE

Interventions

Education and Protocol based management

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

International Society of Nephrology

OTHER

Sponsor Role: collaborator

University of California, San Diego

OTHER

Sponsor Role: lead

Responsible Party

Ravindra Mehta

Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hospital Obrero #2

Cochabamba, , Bolivia

Queen Elizabeth Central Hospital (QECH)

Blantyre, , Malawi

BP Koirala Institute of Health Sciences

Dharān, Sansari District, Nepal

Countries

Bolivia; Malawi; Nepal

Other Identifiers

160610

Identifier Type: -

Identifier Source: org_study_id