Acute Kidney InjuryNCT05167292
Aetiology, Management and Outcomes of Acute Kidney Injury in Samoa.
An observational study of Acute Kidney Injury, run by Dr Annette Kaspar at 1 site in Samoa.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- Observational study
- How many people
- 114 participants
- Where
- 1 siteSamoa
- Study dates
- 1 Dec 2019to 31 May 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All adult patients presenting to TTM Hospital in Samoa during the study period.
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Samoa1 site
Tupua Tamasese Meaole Hospital
Apia, QLD, 0
About this study
Official title: Acute Kidney Injury Among Adults in the Pacific Islands: Incidence, Aetiology, Management and Outcome Measures From the Tertiary Referral Hospital of Samoa.
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.
Read the detailed description
- METHODS 2.1. Ethical approval Ethical approval for the present study was obtained from the Fiji National University College Health Research Ethics Committee (CHREC) and the Government of Samoa Ministry of Health - Health Research Committee (MoH-HRC). Gatekeeper approval was also obtained from the Deputy Director General of the TTM Hospital.
2.2. Study Design and Data Collection This was a single-centre prospective observational study. Participants were recruited from the hospital patient information system. The inclusion criteria for participation were (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. Patients with underlying chronic kidney disease who experienced an episode of AKI during the study period were also included in the present study. Exclusion criteria were (1) patients on chronic haemodialysis, (2) patients with underlying chronic kidney disease with no evidence of AKI, and (3) 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).
The hospital Laboratory Database was accessed to identify all patients admitted to TTM Hospital during the study period with a serum creatinine level greater than 200 micromol/L. This is higher than the reference intervals for normal creatinine levels reported in the literature (60-110 micromol/L for adults males, 45-90 micromol/L for adult females) [10]. This criteria was chosen to align with the criteria used by the Fijian teaching hospital that is affiliated with the Fiji National University: the 200mcmol/L criteria reflects their AKI triage management guidelines based on the low-resourced context. The present study therefore adopted the same criteria to evaluate the similarly low-resourced context of Samoa. A total of 1185 patients were identified, and a request for their complete medical records was made to the Medical Record Department. Each record was reviewed for its suitability, and a total of 1071 records did not meet inclusion criteria. The sample size for the present study was therefore 114 patients.
The data collection form is an adaptation of the form used by the International Society for Nephrology for the Global Snapshot Project [11]. For each participant, the following information was collected:
2.2.1. Demographic and Baseline characteristics
- Demographic Information: age (years), gender (male/female), ethnicity (Samoan/Other).
- Admission Information: Admitting Department (Medica/Surgical/Obstetrics\&Gynecology), risk factors for AKI (age>75 years/Diabetes Mellitus/Chronic Liver Disease/Chronic Heart Failure/Chronic Kidney Disease/anemia (Hb<9g/dL)/none/unknown), AKI acquisition (community/hospital), baseline serum creatinine within previous 12 months (micromole/L).
- Presenting symptoms for suspicion of AKI: Dehydration (diarrhea/vomiting/increased thirst/decreased intake), urinary symptoms (oliguria/polyuria/dysuria/heamaturia/incontinence/urolith passed), swelling (anasarca/face \& neck/ upper limbs/ lower limbs/other), hypotension (MAP<65/shock and use of vasopressors/hemmorrhage), pregnancy and delivery-related symptoms (PV bleeding/coma/seizures/other), Fever, Traumatic injury (site), allergic reaction (specify), poisoning (specify).
- AKI KDIGO criteria-based diagnosis: increase in serum creatinine by 0.3 mg/dL or more within 48 hours OR, increase in serum creatinine to 1.5 times baseline or more within the last 7 days OR, urine output less than 0.5 mL/kg/h for 6 hours.
2.2.2. Aetiology
- Factors contributing to development of AKI: dehydration (diarrhea/vomiting/polyuria/decreased intake), liver (hepatorenal syndrome/cirrhosis/acute liver failure), cardiac (acute myocardial infarct/VHD/heart failure/pulmonary embolism/infective endocarditis/cardiorenal syndrome), hypotension and shock (cardiogenic shock/hemorrhage/sepsis/drug induced/anaphylaxis/post partum/hypotension of unclear cause), acute kidney diseases (acute glomerulonephritis/interstitial nephritis/pyelonephritis/rhabdomyolysis/intravascular hemolysis), urinary obstruction (sone/tumor/prostate condition), infections (leptospirosis/dengue/TB, other bacterial/other viral), pregnancy related (miscarriage with septic shock/puerperal sepsis), systemic diseases (multiple myeloma/SLE/DIC/pre-eclampsia/PPH/hyperemesis gravidarum), nephrotoxic agents (ACEI/ARB, NSAIDS, aminoglycosides/chemotherapy/contrast), poisoning (yes/no).
- Blood parameter on the day AKI was confirmed: Urea (umol/L), creatinine (umol/L), urine output in past 24 hours (mls).
- Known infection site (yes/no), and if yes specify infection site.
- Other organ failures: pulmonary, cardiovascular, hepatic, hematological, neurological, none.
2.2.3. Management
- Non-dialytic treatment at the time of AKI diagnosis: fluid therapy, diuretics, vasosupressors, antibiotics, urinary diversion (percutaneous nephrostomy, cystectomy, urethral catheterization), fluid restriction, other.
- Patient received dialysis (yes/no).
- Indication for starting dialysis: fluid overload, symptomatic uremia, electrolyte or acid-based disturbance, intoxication/poisoning, other.
- Number of days from diagnosis of AKI to initiation of haemodialysis (days).
- Blood parameters on the day hemodialysis was started: Urea (umol/L), creatinine (umol/L), urine output in past 24 hours (mls).
2.2.4. Outcome
- Patient status: Alive/deceased.
- Cause of death: kidney failure, infection/sepsis, cardiovascular, shock, dehydration, hemorrhage, pregnancy-related, liver failure, pulmonary condition, neurological, trauma, poisoning, systemic illness, malignancy, unknown.
2.3. Data analysis The data was analysed using the Microsoft Excel and STATA statistical software packages. Descriptive analysis and pivot tables were performed initially, followed by comparison of binary variables (unpaired t-test significant at p<0.05) and the unadjusted Kaplan Meier curve.
- Conditions
- Acute Kidney Injury
- Being tested
- Observational study
- Keywords
- Pacific Islands; Incidence; Aetiology; Prevention; Complications
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational studyOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
aetiology of AKI
the causes of AKI will be retrieved from the medical records and tallied for reporting in group summary format
Measured: 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.
Measured: 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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2021
- Study start1 Dec 2019
- Primary completion31 May 2020
- Study completion31 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr Annette Kaspar
- Sponsor type
- Other government
- Collaborators
- Fiji National University
- Responsible party
- Sponsor-investigator, Dr Annette Kaspar, Tupua Tamasese Meaole Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05167292
- Sponsor's protocol ID
- 117.19
- Status last verified
- Dec 2021
- First submitted
- 23 Nov 2021
- Last updated
- 22 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: At this time, there is no IPD plan.
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Kidney Injury Among Adults in the Pacific Islands: Incidence, Aetiology, Management and Outcome Measures From the Tertiary Referral Hospital of Samoa.
- ClinicalTrials.gov ID
- NCT05167292
- Acronym / sponsor ID
- 117.19
- Conditions
- Acute Kidney Injury
- Keywords
- Pacific Islands; Incidence; Aetiology; Prevention; Complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Dr Annette KasparOther government
- Collaborators
- Fiji National University
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 31 May 2020 (actual)
- Study completion
- 31 May 2020 (actual)
- First posted
- 22 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- METHODS 2.1. Ethical approval Ethical approval for the present study was obtained from the Fiji National University College Health Research Ethics Committee (CHREC) and the Government of Samoa Ministry of Health - Health Research Committee (MoH-HRC). Gatekeeper approval was also obtained from the Deputy Director General of the TTM Hospital.
2.2. Study Design and Data Collection This was a single-centre prospective observational study. Participants were recruited from the hospital patient information system. The inclusion criteria for participation were (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. Patients with underlying chronic kidney disease who experienced an episode of AKI during the study period were also included in the present study. Exclusion criteria were (1) patients on chronic haemodialysis, (2) patients with underlying chronic kidney disease with no evidence of AKI, and (3) 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).
The hospital Laboratory Database was accessed to identify all patients admitted to TTM Hospital during the study period with a serum creatinine level greater than 200 micromol/L. This is higher than the reference intervals for normal creatinine levels reported in the literature (60-110 micromol/L for adults males, 45-90 micromol/L for adult females) [10]. This criteria was chosen to align with the criteria used by the Fijian teaching hospital that is affiliated with the Fiji National University: the 200mcmol/L criteria reflects their AKI triage management guidelines based on the low-resourced context. The present study therefore adopted the same criteria to evaluate the similarly low-resourced context of Samoa. A total of 1185 patients were identified, and a request for their complete medical records was made to the Medical Record Department. Each record was reviewed for its suitability, and a total of 1071 records did not meet inclusion criteria. The sample size for the present study was therefore 114 patients.
The data collection form is an adaptation of the form used by the International Society for Nephrology for the Global Snapshot Project [11]. For each participant, the following information was collected:
2.2.1. Demographic and Baseline characteristics
- Demographic Information: age (years), gender (male/female), ethnicity (Samoan/Other).
- Admission Information: Admitting Department (Medica/Surgical/Obstetrics\&Gynecology), risk factors for AKI (age>75 years/Diabetes Mellitus/Chronic Liver Disease/Chronic Heart Failure/Chronic Kidney Disease/anemia (Hb<9g/dL)/none/unknown), AKI acquisition (community/hospital), baseline serum creatinine within previous 12 months (micromole/L).
- Presenting symptoms for suspicion of AKI: Dehydration (diarrhea/vomiting/increased thirst/decreased intake), urinary symptoms (oliguria/polyuria/dysuria/heamaturia/incontinence/urolith passed), swelling (anasarca/face \& neck/ upper limbs/ lower limbs/other), hypotension (MAP<65/shock and use of vasopressors/hemmorrhage), pregnancy and delivery-related symptoms (PV bleeding/coma/seizures/other), Fever, Traumatic injury (site), allergic reaction (specify), poisoning (specify).
- AKI KDIGO criteria-based diagnosis: increase in serum creatinine by 0.3 mg/dL or more within 48 hours OR, increase in serum creatinine to 1.5 times baseline or more within the last 7 days OR, urine output less than 0.5 mL/kg/h for 6 hours.
2.2.2. Aetiology
- Factors contributing to development of AKI: dehydration (diarrhea/vomiting/polyuria/decreased intake), liver (hepatorenal syndrome/cirrhosis/acute liver failure), cardiac (acute myocardial infarct/VHD/heart failure/pulmonary embolism/infective endocarditis/cardiorenal syndrome), hypotension and shock (cardiogenic shock/hemorrhage/sepsis/drug induced/anaphylaxis/post partum/hypotension of unclear cause), acute kidney diseases (acute glomerulonephritis/interstitial nephritis/pyelonephritis/rhabdomyolysis/intravascular hemolysis), urinary obstruction (sone/tumor/prostate condition), infections (leptospirosis/dengue/TB, other bacterial/other viral), pregnancy related (miscarriage with septic shock/puerperal sepsis), systemic diseases (multiple myeloma/SLE/DIC/pre-eclampsia/PPH/hyperemesis gravidarum), nephrotoxic agents (ACEI/ARB, NSAIDS, aminoglycosides/chemotherapy/contrast), poisoning (yes/no).
- Blood parameter on the day AKI was confirmed: Urea (umol/L), creatinine (umol/L), urine output in past 24 hours (mls).
- Known infection site (yes/no), and if yes specify infection site.
- Other organ failures: pulmonary, cardiovascular, hepatic, hematological, neurological, none.
2.2.3. Management
- Non-dialytic treatment at the time of AKI diagnosis: fluid therapy, diuretics, vasosupressors, antibiotics, urinary diversion (percutaneous nephrostomy, cystectomy, urethral catheterization), fluid restriction, other.
- Patient received dialysis (yes/no).
- Indication for starting dialysis: fluid overload, symptomatic uremia, electrolyte or acid-based disturbance, intoxication/poisoning, other.
- Number of days from diagnosis of AKI to initiation of haemodialysis (days).
- Blood parameters on the day hemodialysis was started: Urea (umol/L), creatinine (umol/L), urine output in past 24 hours (mls).
2.2.4. Outcome
- Patient status: Alive/deceased.
- Cause of death: kidney failure, infection/sepsis, cardiovascular, shock, dehydration, hemorrhage, pregnancy-related, liver failure, pulmonary condition, neurological, trauma, poisoning, systemic illness, malignancy, unknown.
2.3. Data analysis The data was analysed using the Microsoft Excel and STATA statistical software packages. Descriptive analysis and pivot tables were performed initially, followed by comparison of binary variables (unpaired t-test significant at p<0.05) and the unadjusted Kaplan Meier curve.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult patients presenting to TTM Hospital in Samoa during the study period.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational studyRoutine 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. | Other | – |
Primary outcome
aetiology of AKI
Time frame: 6 months
the causes of AKI will be retrieved from the medical records and tallied for reporting in group summary format
management options chosen to treat AKI
Time frame: 6 months
the management options chosen to treat AKI will be retrieved from the medical records and tallied for reporting in group summary format.
outcome of AKI cases presenting to the emergency department
Time frame: 6 months
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2021.
- Individual participant dataSharing planned: No. At this time, there is no IPD plan.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Kidney Injury, run by Dr Annette Kaspar at 1 site in Samoa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Samoa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
aetiology of AKI (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2021.