NCT06508593

Brief Summary

Clinical evidence suggests that renal injury leads to changes in the structure of the cerebral cortex in patients, suggesting the existence of the renal brain axis. Therefore, some scholars have proposed that AKI may be an important cause of secondary injuries such as delirium. Approximately 60% of AKI patients in clinical practice experience delirium.Although the underlying mechanism associated with acute renal injury and delirium is still unclear, it has been recognized that it increases incidence rate and mortality, prolongs hospital stay, and accelerates long-term cognitive decline. The investigators assume that the serum metabolic profiles of patients with delirium and AKI after cardiac surgery, with delirium only, with AKI only, and without delirium or AKI after surgery can be compared separately to explore the mechanisms of complications and the interaction mechanisms between organ damage after extracorporeal circulation cardiac surgery, and to identify metabolic markers specific to complications, identify patients with increased susceptibility, and provide reference for early diagnosis of complications and basis for early intervention.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 12, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 18, 2024

Completed
2 days until next milestone

Study Start

First participant enrolled

July 20, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

April 6, 2025

Status Verified

April 1, 2025

Enrollment Period

5 months

First QC Date

July 12, 2024

Last Update Submit

April 2, 2025

Conditions

Keywords

AKIDeliriumCardiac surgeryMetabolomics

Outcome Measures

Primary Outcomes (1)

  • Small molecule metabolites specific to complications after extracorporeal circulation cardiac surgery

    Non biased detection of all small molecule metabolites associated with complications after extracorporeal circulation cardiac surgery, and screening of differential metabolites

    1 week

Study Arms (4)

AKI group

Patients developed AKI after cardiac surgery

Diagnostic Test: Serum metabolic profile

Delirium group

Patients developed delirium 5 days after cardiac surgery

Diagnostic Test: Serum metabolic profile

AKI and delirium group

Patients developed AKI and delirium after cardiac surgery

Diagnostic Test: Serum metabolic profile

Control group

Patients didn't develope AKI or delirium after cardiac surgery

Diagnostic Test: Serum metabolic profile

Interventions

Venous serum samples were analyzed for serum metabolic profiles using liquid chromatography-mass spectrometry (LC-MS) and gas chromatography-mass spectrometry (GC-MS) non targeted metabolomics techniques

AKI and delirium groupAKI groupControl groupDelirium group

Eligibility Criteria

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

Patients undergone extracorporeal circulation cardiac surgery

You may qualify if:

  • years old and above
  • Patients undergone elective cardiac surgery
  • History of serum creatinine test within 7 days before surgery
  • Provide venous blood samples
  • Voluntarily participate and sign an informed consent form

You may not qualify if:

  • Patients treated with chronic peritoneum or hemodialysis, prior kidney transplantation, preoperative serum creatinine level\>4.5mg/dL (400 μ mol/L) or end-stage renal disease (defined as glomerular filtration rate\<15ml · min-1 · 1.73m-2)
  • Other related diseases that have been previously confirmed to have cognitive impairment, or records of using drugs targeting cognitive impairment during the onset period
  • Individuals with severe speech, visual, hearing, or mental impairments that affect cognitive scale assessment
  • Individuals with a history of brain tumors, traumatic brain injury, brain parasitic diseases, and other diseases that may cause cognitive impairment
  • Individuals with a history of alcohol and drug addiction
  • Pregnant and lactating women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xijing Hospital

Xi'an, Shaanxi, 710032, China

Location

Related Publications (1)

  • Liu M, Liang Y, Chigurupati S, Lathia JD, Pletnikov M, Sun Z, Crow M, Ross CA, Mattson MP, Rabb H. Acute kidney injury leads to inflammation and functional changes in the brain. J Am Soc Nephrol. 2008 Jul;19(7):1360-70. doi: 10.1681/ASN.2007080901. Epub 2008 Apr 2.

    PMID: 18385426BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

MeSH Terms

Conditions

Acute Kidney InjuryEmergence DeliriumDelirium

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and SymptomsNeurocognitive DisordersMental Disorders

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator, Head of Anesthesia Clinical Research Center, Xijing Hospital

Study Record Dates

First Submitted

July 12, 2024

First Posted

July 18, 2024

Study Start

July 20, 2024

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

April 6, 2025

Record last verified: 2025-04

Locations