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OpenTrials
Completed

NCT Number: NCT04631289

Preadmission Metformin Exposure and Incidence of Acute Kidney Injury

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.

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Key information

Conditions

AKI Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

16 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

SAHGuangzhouMU

Guangzhou, Guangdong, China

About this study

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 .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Incidence of AKI

    Time frame: within 7days in the ICU

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

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital of Guangzhou Medical University

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Nov 17, 2020
Registry last updated
Nov 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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