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Preadmission Metformin Exposure and Incidence of Acute Kidney Injury

Sponsor
Second Affiliated Hospital of Guangzhou Medical University (Other)
Overall Status
Completed
CT.gov ID
NCT04631289
Collaborator
(none)
3,841
Enrollment
1
Location
3.3
Actual Duration (Months)
1157.5
Patients Per Site Per Month

Study Details

Study Description

Brief 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. 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.

Condition or Disease Intervention/Treatment Phase

    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

    Study Type:
    Observational
    Actual Enrollment :
    3841 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    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
    Actual Study Start Date :
    Aug 1, 2020
    Actual Primary Completion Date :
    Sep 1, 2020
    Actual Study Completion Date :
    Nov 10, 2020

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of AKI [within 7days in the ICU]

      AKI was defined according to the Kidney Disease: Improving Global Outcomes (KDIGO) criteria.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    16 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • type 2 diabetes

    • 16 years old and <90 years old

    • without AKI

    Exclusion Criteria:

    • CKD

    • data error

    • type 1 diabetes

    • diabetes patients with pregnancy

    • no metformin record

    • with AKI

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 SAHGuangzhouMU Guangzhou Guangdong China

    Sponsors and Collaborators

    • Second Affiliated Hospital of Guangzhou Medical University

    Investigators

    • Principal Investigator: Shikun Qian, Second Affiliated Hospital of Guangzhou Medical University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Second Affiliated Hospital of Guangzhou Medical University
    ClinicalTrials.gov Identifier:
    NCT04631289
    Other Study ID Numbers:
    • met on AKI
    First Posted:
    Nov 17, 2020
    Last Update Posted:
    Nov 17, 2020
    Last Verified:
    Nov 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Second Affiliated Hospital of Guangzhou Medical University
    Metformin;AKI; Type 2 diabetes; ICU
    Additional relevant MeSH terms:
    Acute Kidney Injury

    Study Results

    No Results Posted as of Nov 17, 2020