NCT02912611

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,101

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2016

Geographic Reach
3 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 21, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 23, 2016

Completed
8 days until next milestone

Study Start

First participant enrolled

October 1, 2016

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 29, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2018

Completed
Last Updated

July 28, 2020

Status Verified

July 1, 2020

Enrollment Period

12 months

First QC Date

September 21, 2016

Last Update Submit

July 24, 2020

Conditions

Acute Kidney Injury

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Moderate and High risk for AKI

OTHER
Procedure: Education and Protocol based management

Interventions

Education and Protocol based managementPROCEDURE
Moderate and High risk for AKI

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Decreased urine volume
  • Hypotension/ shock
  • Coma
  • Jaundice
  • Confusion
  • Dyspnea
  • Symptoms of respiratory infection
  • Petechia, ecchymosis, bleeding
  • Hypertension (in pregnancy)

You may not qualify if:

  • Chronic kidney disease in patients receiving regular dialysis treatment
  • Kidney transplant patients
  • Unable to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Hospital Obrero #2

Cochabamba, Bolivia

Location

Queen Elizabeth Central Hospital (QECH)

Blantyre, Malawi

Location

BP Koirala Institute of Health Sciences

Dharān, Sansari District, 56700, Nepal

Location

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

September 21, 2016

First Posted

September 23, 2016

Study Start

October 1, 2016

Primary Completion

September 29, 2017

Study Completion

March 31, 2018

Last Updated

July 28, 2020

Record last verified: 2020-07

Locations

MA(1)NE(1)BO(1)