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

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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
Sponsor:
Collaborator:
International Society of Nephrology
Information provided by (Responsible Party):
Ravindra Mehta, University of California, San Diego

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.


Condition or disease Intervention/treatment Phase
Acute Kidney Injury Procedure: Education and Protocol based management Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3600 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Study Start Date : October 2016
Estimated Primary Completion Date : June 2017

Arm Intervention/treatment
Moderate and High risk for AKI Procedure: Education and Protocol based management



Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Contacts
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Contact: Etienne Macedo, MD, PhD 619 5437754 ext 37754 emmacedo@ucsd.edu

Locations
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Bolivia
Hospital Obrero #2 Recruiting
Cochabamba, Bolivia
Contact: Rolando Claure, MD         
Malawi
Queen Elizabeth Central Hospital (QECH) Recruiting
Blantyre, Malawi
Contact: Ulla Hemmila         
Nepal
BP Koirala Institute of Health Sciences Recruiting
Dharan, Nepal
Contact: Sanjib Sharma, MD         
Sponsors and Collaborators
University of California, San Diego
International Society of Nephrology

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Responsible Party: Ravindra Mehta, Professor of Medicine, University of California, San Diego
ClinicalTrials.gov Identifier: NCT02912611     History of Changes
Other Study ID Numbers: 160610
First Posted: September 23, 2016    Key Record Dates
Last Update Posted: November 25, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
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Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases