Detection and Management of Acute Kidney Injury (AKI) in Low and Low Middle Income Countries: A Pilot Feasibility Project
Primary Purpose
Acute Kidney Injury
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Education and Protocol based management
Sponsored by
About this trial
This is an interventional diagnostic trial for Acute Kidney Injury
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
Sites / Locations
- Hospital Obrero #2
- Queen Elizabeth Central Hospital (QECH)
- BP Koirala Institute of Health Sciences
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Moderate and High risk for AKI
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02912611
First Posted
September 21, 2016
Last Updated
July 24, 2020
Sponsor
University of California, San Diego
Collaborators
International Society of Nephrology
1. Study Identification
Unique Protocol Identification Number
NCT02912611
Brief Title
Detection and Management of Acute Kidney Injury (AKI) in Low and Low Middle Income Countries: A Pilot Feasibility Project
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
October 1, 2016 (undefined)
Primary Completion Date
September 29, 2017 (Actual)
Study Completion Date
March 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego
Collaborators
International Society of Nephrology
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Kidney Injury
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2101 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Moderate and High risk for AKI
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
Education and Protocol based management
Primary Outcome Measure Information:
Title
Assess the feasibility of implementing an education and training program to optimize care of AKI
Description
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.
Time Frame
1 year
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Hospital Obrero #2
City
Cochabamba
Country
Bolivia
Facility Name
Queen Elizabeth Central Hospital (QECH)
City
Blantyre
Country
Malawi
Facility Name
BP Koirala Institute of Health Sciences
City
Dharān Bāzār
State/Province
Sansari District
ZIP/Postal Code
56700
Country
Nepal
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Detection and Management of Acute Kidney Injury (AKI) in Low and Low Middle Income Countries: A Pilot Feasibility Project
We'll reach out to this number within 24 hrs