AKINCT04631289
Preadmission Metformin Exposure and Incidence of Acute Kidney Injury
An observational study of AKI, run by Second Affiliated Hospital of Guangzhou Medical University at 1 site in China.
Trial summary
More than 50% of ICU patients suffer from Acute kidney injury (AKI). Metformin shows protective properties in kidney disease. Our study aimed to validate AKI incidence among diabetes patients in the ICU with or without preadmission metformin exposure. Read more about this study
- Who is it for?
- Ages 16 to 90 years
- Conditions the study is for
- AKI
- How many people
- 3,841 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2020to 10 Nov 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 16 to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Type 2 diabetes patients without AKI were eligible in our study. AKI was defined according to the Kidney Disease: Improving Global Outcomes (KDIGO) criteria. KDIGO criteria are as follows: increase in SCr to ≥1.5 times baseline must have occurred within the prior 7 days; or ≥0.3 mg/dl increase in serum creatinine (SCr) occurred within 48 h; or urine volume <0.5 ml/kg/h for 6 h or more. The minimum of the SCr values available within the 7 days before admission was used as the baseline SCr[12]. When the preadmission SCr was not available, the first SCr measured at admission was used as the baseline SCr. The diagnosis of type 2 diabetes was based on International Classification of Disease, Ninth Revision (ICD-9). We only included adult patients (age>16 years).
Who may be able to join
- type 2 diabetes
- >16 years old and <90 years old
- without AKI
Who cannot join
- CKD
- data error
- type 1 diabetes
- diabetes patients with pregnancy
- no metformin record
- with AKI
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Association of Preadmission Metformin Exposure and Incidence of Acute Kidney Injury Within 7 Days in Patients With Type 2 Diabetes in Intensive Care Unit: a Retrospective Cohort Study
More than 50% of ICU patients suffer from Acute kidney injury (AKI). Metformin shows protective properties in kidney disease. Our study aimed to validate AKI incidence among diabetes patients in the ICU with or without preadmission metformin exposure. We included non-AKI patients with type 2 diabetes in Medical Information Mart for Intensive Care (MIMIC)-III database. Incidence of AKI and mortality were compared between those with and without preadmission prescriptions.
Read the detailed description
Emerged as a major public healthy problem, Acute kidney injury (AKI) is now influencing millions of people worldwide and leading to reduced survival, increased progression of latent chronic kidney disease (CKD), and even new onset of CKD. More than half of intensive care unit (ICU) patients underwent AKI in a recent multinational cross-sectional study, often resulting in the need for renal replacement therapy with a high socio-economic impact for the patients.The effective precaution and treatment strategy remains limited.
As the most general and first-line biguanide antihyperglycemic drug, metformin has anti-inflammatory characteristics and is related with decreased all-cause mortality compared with other antihyperglycemics.. In some clinical trials and experimental studies conducted on divergent rodent models representing various types of kidney diseases going from AKI to CKD, metformin has been shown beneficial effects on the kidney. Moreover, preadmission metformin exposure is associated with a lower rate of 28-day mortality among AKI patients showed in several clinical studies.
However, in critical care patients with type 2 diabetes, the evidence of preadmission metformin usage decreasing a risk of AKI incidence is still absented. Therefore we performed a retrospective cohort study to validate the association of preadmission metformin exposure and AKI incidence in patients with diabetes in the ICU .
- Conditions
- AKI
- Keywords
- Metformin;AKI; Type 2 diabetes; ICU
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| metformin/non-metformin group | Preadmission metformin exposure was defined as a record of metformin usage in "Medications on admission" in MIMIC-III. Metformin group included non-AKI type 2 diabetes patients with preadmission metformin exposure. Non-metformin group included non-AKI type 2 diabetes patients without preadmission metformin exposure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of AKI
AKI was defined according to the Kidney Disease: Improving Global Outcomes (KDIGO) criteria.
Measured: within 7days in the ICU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2020
- Study start1 Aug 2020
- Primary completion1 Sep 2020
- Study completion10 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AKIStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital of Guangzhou Medical UniversityThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 3,841 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shikun Qian, Principal investigator, Second Affiliated Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04631289
- Sponsor's protocol ID
- met on AKI
- Status last verified
- Nov 2020
- First submitted
- 12 Nov 2020
- Last updated
- 17 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Preadmission Metformin Exposure and Incidence of Acute Kidney Injury Within 7 Days in Patients With Type 2 Diabetes in Intensive Care Unit: a Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT04631289
- Acronym / sponsor ID
- met on AKI
- Conditions
- AKI
- Keywords
- Metformin;AKI; Type 2 diabetes; ICU
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,841 participants (actual)
- Lead sponsor
- Second Affiliated Hospital of Guangzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 1 Sep 2020 (actual)
- Study completion
- 10 Nov 2020 (actual)
- First posted
- 17 Nov 2020 (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.
More than 50% of ICU patients suffer from Acute kidney injury (AKI). Metformin shows protective properties in kidney disease. Our study aimed to validate AKI incidence among diabetes patients in the ICU with or without preadmission metformin exposure. We included non-AKI patients with type 2 diabetes in Medical Information Mart for Intensive Care (MIMIC)-III database. Incidence of AKI and mortality were compared between those with and without preadmission prescriptions.
Detailed description
Emerged as a major public healthy problem, Acute kidney injury (AKI) is now influencing millions of people worldwide and leading to reduced survival, increased progression of latent chronic kidney disease (CKD), and even new onset of CKD. More than half of intensive care unit (ICU) patients underwent AKI in a recent multinational cross-sectional study, often resulting in the need for renal replacement therapy with a high socio-economic impact for the patients.The effective precaution and treatment strategy remains limited.
As the most general and first-line biguanide antihyperglycemic drug, metformin has anti-inflammatory characteristics and is related with decreased all-cause mortality compared with other antihyperglycemics.. In some clinical trials and experimental studies conducted on divergent rodent models representing various types of kidney diseases going from AKI to CKD, metformin has been shown beneficial effects on the kidney. Moreover, preadmission metformin exposure is associated with a lower rate of 28-day mortality among AKI patients showed in several clinical studies.
However, in critical care patients with type 2 diabetes, the evidence of preadmission metformin usage decreasing a risk of AKI incidence is still absented. Therefore we performed a retrospective cohort study to validate the association of preadmission metformin exposure and AKI incidence in patients with diabetes in the ICU .
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| metformin/non-metformin group | – | –Preadmission metformin exposure was defined as a record of metformin usage in "Medications on admission" in MIMIC-III. Metformin group included non-AKI type 2 diabetes patients with preadmission metformin exposure. Non-metformin group included non-AKI type 2 diabetes patients without preadmission metformin exposure. |
Who may qualify
- Ages
- 16 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Type 2 diabetes patients without AKI were eligible in our study. AKI was defined according to the Kidney Disease: Improving Global Outcomes (KDIGO) criteria. KDIGO criteria are as follows: increase in SCr to ≥1.5 times baseline must have occurred within the prior 7 days; or ≥0.3 mg/dl increase in serum creatinine (SCr) occurred within 48 h; or urine volume <0.5 ml/kg/h for 6 h or more. The minimum of the SCr values available within the 7 days before admission was used as the baseline SCr[12]. When the preadmission SCr was not available, the first SCr measured at admission was used as the baseline SCr. The diagnosis of type 2 diabetes was based on International Classification of Disease, Ninth Revision (ICD-9). We only included adult patients (age>16 years).
Key inclusion criteria (3 listed)
- type 2 diabetes
- >16 years old and <90 years old
- without AKI
Key exclusion criteria (6 listed)
- CKD
- data error
- type 1 diabetes
- diabetes patients with pregnancy
- no metformin record
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of AKI
Time frame: within 7days in the ICU
AKI was defined according to the Kidney Disease: Improving Global Outcomes (KDIGO) criteria.
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 17 Nov 2020.
- Individual participant dataSharing planned: Undecided
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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.
Shikun Qian principal investigator
Second Affiliated Hospital of Guangzhou Medical University
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 AKI, run by Second Affiliated Hospital of Guangzhou Medical University at 1 site in China.
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 6 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 17 Nov 2020. 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 China. 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?
Incidence of AKI (time frame: within 7days in the ICU). 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 17 Nov 2020.