NCT05903677

Brief Summary

Detection the relationship between preoperative ionized magnesium levels and the risk of acute kidney injury after cardiac surgery.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2023

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 2, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 15, 2023

Completed
16 days until next milestone

Study Start

First participant enrolled

July 1, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
Last Updated

June 15, 2023

Status Verified

June 1, 2023

Enrollment Period

11 months

First QC Date

June 2, 2023

Last Update Submit

June 11, 2023

Conditions

Outcome Measures

Primary Outcomes (3)

  • Post cardiac surgery AKI according to KDIGO criteria with low preoperative magnesium level

    Measuring preoperative magnesium level and postoperative kidney functions in form of serum creatinine in umol/L , BUN in mmol/L and urine output ml/h to detect the relationship between preoperative low magnesium level and risk of acute kidney injury after cardiac surgery.

    Baseline

  • Post cardiac surgery AKI according to KDIGO criteria with normal or high preoperative magnesium level

    Measuring preoperative magnesium level and postoperative serum creatinine, BUN and urine output to detect the relationship between preoperative magnesium level and risk of acute kidney injury after cardiac surgery.

    basline

  • Post cardiac surgery normal kidney functions with low preoperative magnesium level

    Measuring preoperative magnesium level and postoperative serum creatinine, BUN and urine output to detect the relationship between preoperative magnesium level and risk of acute kidney injury after cardiac surgery.

    basline

Study Arms (1)

Adults undergoing cardiac surgery without preoperative renal affection

Detect the preoperative magnesium levels in adults undergoing cardiac surgery without preoperative renal affection and follow up if they developed postoperative acute kidney injury or not.

Other: magnesium levels

Interventions

Detection of the relationship between cardiac surgery associated AKI and preoperative magnesium levels.

Also known as: Serum creatinine and blood urea nitrogen (BUN)
Adults undergoing cardiac surgery without preoperative renal affection

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

people more than or equal 18 years who undergo open heart surgery between July 2023 to July 2024 and not known to have kidney disease .

You may qualify if:

  • patients more than or equal 18 yrs.
  • patients undergoing cardiac surgery between July 2023 and July 2024

You may not qualify if:

  • patients with known Kidney disease.
  • patients less than 18 yrs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Koh HB, Jung CY, Kim HW, Kwon JY, Kim NH, Kim HJ, Jhee JH, Han SH, Yoo TH, Kang SW, Park JT. Preoperative Ionized Magnesium Levels and Risk of Acute Kidney Injury After Cardiac Surgery. Am J Kidney Dis. 2022 Nov;80(5):629-637.e1. doi: 10.1053/j.ajkd.2022.03.004. Epub 2022 Apr 23.

    PMID: 35469966BACKGROUND

MeSH Terms

Interventions

Blood Urea Nitrogen

Intervention Hierarchy (Ancestors)

Blood Chemical AnalysisClinical Chemistry TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisKidney Function TestsDiagnostic Techniques, UrologicalInvestigative Techniques

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident doctor

Study Record Dates

First Submitted

June 2, 2023

First Posted

June 15, 2023

Study Start

July 1, 2023

Primary Completion

June 1, 2024

Study Completion

July 1, 2024

Last Updated

June 15, 2023

Record last verified: 2023-06