NCT05167292

Brief Summary

Single-centre prospective observational study. Participants were recruited from the hospital patient information system. The inclusion criteria for participation was (1) adults (\>18 years) admitted to general wards of Tupua Tamasese Meaole (TTM) Hospital with a diagnosis of AKI between the 1st December 2019 and the 31st of May 2020, and (2) serum creatinine level of \>200 micromol/L, and (3) compliance with the current Kidney Disease Improving Global Outcomes (KDIGO) criteria for AKI diagnosis. The data collection form was adapted from the International Society for Nephrology - Global Snapshot Project, and recorded demographic and baseline characteristics, precipitating causes of AKI, treatment/management, and outcomes measures.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
114

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

December 1, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2020

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

November 23, 2021

Completed
29 days until next milestone

First Posted

Study publicly available on registry

December 22, 2021

Completed
Last Updated

December 22, 2021

Status Verified

December 1, 2021

Enrollment Period

6 months

First QC Date

November 23, 2021

Last Update Submit

December 7, 2021

Conditions

Keywords

Pacific Islands; Incidence; Aetiology; Prevention; Complications

Outcome Measures

Primary Outcomes (3)

  • aetiology of AKI

    the causes of AKI will be retrieved from the medical records and tallied for reporting in group summary format

    6 months

  • management options chosen to treat AKI

    the management options chosen to treat AKI will be retrieved from the medical records and tallied for reporting in group summary format.

    6 months

  • outcome of AKI cases presenting to the emergency department

    the outcomes of AKI cases presenting to the emergency department will be retrieved from the medical records and tallied for reporting in group summary format

    6 months

Interventions

Routine clinical care was provided to all AKI cases presenting to the TTM Hospital in Samoa. This prospective observational study reviewed incidence, aetiology and outcomes for these cases.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All adult patients presenting to TTM Hospital in Samoa during the study period.

You may qualify if:

  • adults (\>18 years) admitted to general wards of Tupua Tamasese Meaole (TTM) Hospital with a diagnosis of AKI between the 1st December 2019 and the 31st of May 2020
  • serum creatinine level of \>200 micromol/L
  • compliance with the current Kidney Disease Improving Global Outcomes (KDIGO) criteria for AKI diagnosis

You may not qualify if:

  • patients on chronic haemodialysis
  • patients with underlying chronic kidney disease with no evidence of AKI
  • patients for whom it was not possible to ascertain a diagnosis (i.e., patients with one elevated serum creatinine result and no subsequent follow-up haematology)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tupua Tamasese Meaole Hospital

Apia, QLD, 0, Samoa

Location

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Observation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Head of Audiology

Study Record Dates

First Submitted

November 23, 2021

First Posted

December 22, 2021

Study Start

December 1, 2019

Primary Completion

May 31, 2020

Study Completion

May 31, 2020

Last Updated

December 22, 2021

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

At this time, there is no IPD plan.

Locations