NCT06125249

Brief Summary

The goal of this observational study is to explore the value of Humanin for early diagnosis and short-term prognosis of AKI patients after heart transplantation. The main question it aims to answer are:whether Humanin can be a novel marker for predicting AKI after heart transplantation Researchers will compare the Humanin concentration in patients with AKI did not occur after heart transplantation to see if Humanin can be a novel marker for predicting AKI after heart transplantation

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2022

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

July 1, 2022

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

November 5, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 9, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

November 9, 2023

Status Verified

November 1, 2023

Enrollment Period

1.9 years

First QC Date

November 5, 2023

Last Update Submit

November 5, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • Humanin concentration

    Highest measured value used

    3 months

  • Serum creatinine concentration

    Meets KDIGO's definition of AKI

    3 months

Study Arms (2)

Patients with AKI after heart transplantation

AKI occurs in patients after heart transplantation

Patients did not develop AKI after heart transplantation

Patients who do not develop AKI after heart transplantation

Eligibility Criteria

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

Heart transplant patients from Guangdong Provincial People's Hospital from September 2022 to May 2024

You may qualify if:

  • Guangdong Provincial People's Hospital performs heart transplantation;Adult patients ≥ 18 years of age, male or female;Basic renal function is normal before surgery;The patient's baseline medical records are complete, including basic heart diseases, comorbidities, hemoglobin, renal function, urine protein quantification, serum albumin, lactic acid, C-reactive protein, heart transplantation operation time, preoperative and postoperative medication and blood pressure, blood transfusion history, ICU length of stay, cardiac ultrasound (including LVEF), etc;

You may not qualify if:

  • Age\< 18 years;Baseline data were missing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guangdong Provincial People's Hospital

Guangdong, Guangzhou, 510000, China

RECRUITING

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • zhilian PP li, doctor

    Guangdong Provincial People's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

zhilian li, doctor

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Deputy Chief Physician

Study Record Dates

First Submitted

November 5, 2023

First Posted

November 9, 2023

Study Start

July 1, 2022

Primary Completion

June 1, 2024

Study Completion

June 1, 2024

Last Updated

November 9, 2023

Record last verified: 2023-11

Locations