Detection and Management of Acute Kidney Injury (AKI) in Low and Low Middle Income Countries: A Pilot Feasibility Project
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02912611|
Recruitment Status : Unknown
Verified November 2016 by Ravindra Mehta, University of California, San Diego.
Recruitment status was: Recruiting
First Posted : September 23, 2016
Last Update Posted : November 25, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Acute Kidney Injury||Procedure: Education and Protocol based management||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||3600 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||October 2016|
|Estimated Primary Completion Date :||June 2017|
|Moderate and High risk for AKI||
Procedure: Education and Protocol based management
- Assess the feasibility of implementing an education and training program to optimize care of AKI [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02912611
|Contact: Etienne Macedo, MD, PhD||619 5437754 ext email@example.com|
|Hospital Obrero #2||Recruiting|
|Contact: Rolando Claure, MD|
|Queen Elizabeth Central Hospital (QECH)||Recruiting|
|Contact: Ulla Hemmila|
|BP Koirala Institute of Health Sciences||Recruiting|
|Contact: Sanjib Sharma, MD|