Preadmission Metformin Exposure and Incidence of Acute Kidney Injury

NCT04631289 | Completed

• 1 other identifier: met on AKI
• Study Type: observational
• Target: 3,841
• Locations: 1 country
• Sites: 1

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.

Conditions

AKI

Keywords

Metformin;AKI; Type 2 diabetes; ICU

Outcome Measures

Primary Outcomes (1)

• Incidence of AKI

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

  within 7days in the ICU

Study Arms (1)

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.

Eligibility Criteria

• Age: 16 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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).

You may qualify if:

• type 2 diabetes
• \>16 years old and \<90 years old
• without AKI

You may not qualify if:

• CKD
• data error
• type 1 diabetes
• diabetes patients with pregnancy
• no metformin record
• with AKI

Sponsors & Collaborators

• Second Affiliated Hospital of Guangzhou Medical University: lead

Study Sites (1)

SAHGuangzhouMU

Guangzhou, Guangdong, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Shikun Qian

  Second Affiliated Hospital of Guangzhou Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2020
• First Posted: November 17, 2020
• Study Start: August 1, 2020
• Primary Completion: September 1, 2020
• Study Completion: November 10, 2020
• Last Updated: November 17, 2020

Record last verified: 2020-11

Locations

CN (1)